Trial Outcomes & Findings for Trial to Compare Time to Response in the Symptoms of Anxiety to Concomitant Treatment With Niravam™ and an SSRI or SNRI to Treatment With an SSRI or SNRI Alone in Subjects With Generalized Anxiety Disorder or Panic Disorder (NCT NCT00266409)
NCT ID: NCT00266409
Last Updated: 2014-10-27
Results Overview
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Thus total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented.
COMPLETED
PHASE4
418 participants
10 weeks
2014-10-27
Participant Flow
Participants Flow shows 418 subjects that have been enrolled and randomized. The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
Baseline Characteristics are only available for the Intent-to-treat population (subjects who received one dose of SSRI/SNRI and/or Niravam and have an assessment beyond the Baseline assessment)
Participant milestones
| Measure |
Panic: Niravam+SSRI/SNRI
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
137
|
138
|
72
|
71
|
|
Overall Study
COMPLETED
|
92
|
92
|
55
|
49
|
|
Overall Study
NOT COMPLETED
|
45
|
46
|
17
|
22
|
Reasons for withdrawal
| Measure |
Panic: Niravam+SSRI/SNRI
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
6
|
1
|
2
|
|
Overall Study
Adverse Event
|
7
|
2
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
18
|
21
|
6
|
8
|
|
Overall Study
Withdrawal by Subject
|
6
|
10
|
3
|
9
|
|
Overall Study
Protocol Violation
|
5
|
3
|
4
|
2
|
|
Overall Study
Other
|
7
|
4
|
2
|
0
|
Baseline Characteristics
Trial to Compare Time to Response in the Symptoms of Anxiety to Concomitant Treatment With Niravam™ and an SSRI or SNRI to Treatment With an SSRI or SNRI Alone in Subjects With Generalized Anxiety Disorder or Panic Disorder
Baseline characteristics by cohort
| Measure |
Panic: Niravam+SSRI/SNRI
n=125 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=120 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=67 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=62 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
Total
n=374 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
120 Participants
n=39 Participants
|
119 Participants
n=41 Participants
|
66 Participants
n=35 Participants
|
61 Participants
n=31 Participants
|
366 Participants
n=146 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
8 Participants
n=146 Participants
|
|
Age, Continuous
|
40.1 years
STANDARD_DEVIATION 12.24 • n=39 Participants
|
38.1 years
STANDARD_DEVIATION 12.55 • n=41 Participants
|
40.1 years
STANDARD_DEVIATION 12.64 • n=35 Participants
|
43.6 years
STANDARD_DEVIATION 12.20 • n=31 Participants
|
40 years
STANDARD_DEVIATION 12 • n=146 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=39 Participants
|
93 Participants
n=41 Participants
|
50 Participants
n=35 Participants
|
42 Participants
n=31 Participants
|
287 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=39 Participants
|
27 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
20 Participants
n=31 Participants
|
87 Participants
n=146 Participants
|
|
Region of Enrollment
United States
|
125 participants
n=39 Participants
|
120 participants
n=41 Participants
|
67 participants
n=35 Participants
|
62 participants
n=31 Participants
|
374 participants
n=146 Participants
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: Intent-to-treat population
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Thus total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=125 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=120 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=67 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=62 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates)
Week 1
|
1.60 cumulative percent of responders
|
0.83 cumulative percent of responders
|
1.49 cumulative percent of responders
|
1.61 cumulative percent of responders
|
|
Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates)
Week 2
|
3.20 cumulative percent of responders
|
21.73 cumulative percent of responders
|
32.93 cumulative percent of responders
|
27.52 cumulative percent of responders
|
|
Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates)
Week 3
|
45.83 cumulative percent of responders
|
39.43 cumulative percent of responders
|
51.22 cumulative percent of responders
|
48.89 cumulative percent of responders
|
|
Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates)
Week 4
|
59.22 cumulative percent of responders
|
52.40 cumulative percent of responders
|
57.32 cumulative percent of responders
|
62.14 cumulative percent of responders
|
|
Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates)
Week 5
|
69.68 cumulative percent of responders
|
65.99 cumulative percent of responders
|
66.47 cumulative percent of responders
|
65.92 cumulative percent of responders
|
|
Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates)
Week 6
|
71.57 cumulative percent of responders
|
69.79 cumulative percent of responders
|
69.66 cumulative percent of responders
|
71.94 cumulative percent of responders
|
|
Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates)
Week 7
|
74.59 cumulative percent of responders
|
74.11 cumulative percent of responders
|
74.66 cumulative percent of responders
|
73.94 cumulative percent of responders
|
|
Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates)
Week 8
|
76.62 cumulative percent of responders
|
76.27 cumulative percent of responders
|
76.47 cumulative percent of responders
|
73.94 cumulative percent of responders
|
|
Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Intent-to-treat Population (Kaplan-Meier-estimates)
Weeks 9 to 10
|
83.30 cumulative percent of responders
|
82.20 cumulative percent of responders
|
83.82 cumulative percent of responders
|
76.11 cumulative percent of responders
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: Per Protocol Population (subjects of ITT population who have no major protocol violations)
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Total possible score is 56. Kaplan-Meier-analysis was performed and Kaplan-Meier estimates (cumulative percent of subjects responding) are presented.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=104 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=106 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=53 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=49 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates)
Week 1
|
1.92 cumulative percent of responders
|
0.94 cumulative percent of responders
|
1.89 cumulative percent of responders
|
2.04 cumulative percent of responders
|
|
Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates)
Week 2
|
35.58 cumulative percent of responders
|
24.53 cumulative percent of responders
|
33.96 cumulative percent of responders
|
30.78 cumulative percent of responders
|
|
Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates)
Week 3
|
51.23 cumulative percent of responders
|
41.54 cumulative percent of responders
|
52.83 cumulative percent of responders
|
53.16 cumulative percent of responders
|
|
Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates)
Week 4
|
63.18 cumulative percent of responders
|
54.19 cumulative percent of responders
|
58.49 cumulative percent of responders
|
67.21 cumulative percent of responders
|
|
Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates)
Week 5
|
75.45 cumulative percent of responders
|
67.59 cumulative percent of responders
|
67.92 cumulative percent of responders
|
71.89 cumulative percent of responders
|
|
Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates)
Week 6
|
77.59 cumulative percent of responders
|
71.94 cumulative percent of responders
|
71.70 cumulative percent of responders
|
79.56 cumulative percent of responders
|
|
Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates)
Week 7
|
79.83 cumulative percent of responders
|
75.77 cumulative percent of responders
|
77.70 cumulative percent of responders
|
79.56 cumulative percent of responders
|
|
Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates)
Week 8
|
80.95 cumulative percent of responders
|
78.32 cumulative percent of responders
|
79.93 cumulative percent of responders
|
79.56 cumulative percent of responders
|
|
Cumulative Percent of Participants Showing a Response in the Symptoms of Anxiety (Decrease in Total Hamilton Anxiety (HAM-A) -Score of >=50%) in the Per Protocol Population (Kaplan-Meier-estimates)
Week 9 to 10
|
86.60 cumulative percent of responders
|
84.82 cumulative percent of responders
|
86.62 cumulative percent of responders
|
82.48 cumulative percent of responders
|
SECONDARY outcome
Timeframe: Baseline and 1 weekPopulation: ITT population, but only subjects with values at baseline and time point are included in the analysis
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=112 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=109 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=63 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=57 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in the Total HAM-A Score After 1 Week
|
-9.3 Units on a scale
Standard Deviation 11.50
|
-5.8 Units on a scale
Standard Deviation 9.04
|
-7.8 Units on a scale
Standard Deviation 7.43
|
-4.6 Units on a scale
Standard Deviation 8.33
|
SECONDARY outcome
Timeframe: Baseline and 2 WeeksPopulation: ITT Population, only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=108 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=103 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=61 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=53 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in the Total HAM-A Score After 2 Weeks
|
-11.6 Units on a scale
Standard Deviation 10.98
|
-8.2 Units on a scale
Standard Deviation 9.37
|
-10.0 Units on a scale
Standard Deviation 8.75
|
-6.1 Units on a scale
Standard Deviation 9.06
|
SECONDARY outcome
Timeframe: Baseline and 3 weeksPopulation: ITT population, only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=101 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=92 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=58 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=52 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in the Total HAM-A Score After 3 Weeks
|
-14.3 Units on a scale
Standard Deviation 11.81
|
-12.9 Units on a scale
Standard Deviation 11.03
|
-10.9 Units on a scale
Standard Deviation 9.70
|
-9.5 Units on a scale
Standard Deviation 9.49
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: ITT population, only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=97 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=90 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=54 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=48 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in the Total HAM-A Score After 4 Weeks
|
-15.2 Units on a scale
Standard Deviation 11.66
|
-13.7 Units on a scale
Standard Deviation 10.58
|
-12.9 Units on a scale
Standard Deviation 9.47
|
-8.3 Units on a scale
Standard Deviation 8.35
|
SECONDARY outcome
Timeframe: Baseline and 5 weeksPopulation: ITT population, only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=89 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=81 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=51 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=48 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in the Total HAM-A Score After 5 Weeks
|
-16.7 Units on a scale
Standard Deviation 11.81
|
-14.4 Units on a scale
Standard Deviation 11.69
|
-13.3 Units on a scale
Standard Deviation 8.41
|
-10.3 Units on a scale
Standard Deviation 10.99
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: ITT population, only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=87 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=81 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=47 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=47 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in the Total HAM-A Score After 6 Weeks
|
-17.7 Units on a scale
Standard Deviation 11.94
|
-15.1 Units on a scale
Standard Deviation 11.59
|
-13.4 Units on a scale
Standard Deviation 8.00
|
-11.0 Units on a scale
Standard Deviation 10.44
|
SECONDARY outcome
Timeframe: Baseline and 7 weeksPopulation: ITT population, only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=83 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=82 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=53 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=49 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in the Total HAM-A Score After 7 Weeks
|
-17.7 Units on a scale
Standard Deviation 12.75
|
-15.6 Units on a scale
Standard Deviation 11.78
|
-13.3 Units on a scale
Standard Deviation 8.85
|
-11.3 Units on a scale
Standard Deviation 11.32
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: ITT population, only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=84 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=84 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=53 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=47 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in the Total HAM-A Score After 8 Weeks
|
-18.5 Units on a scale
Standard Deviation 13.38
|
-16.6 Units on a scale
Standard Deviation 10.72
|
-13.9 Units on a scale
Standard Deviation 8.71
|
-12.3 Units on a scale
Standard Deviation 9.49
|
SECONDARY outcome
Timeframe: Baseline and at endpoint during the 8 week treatment periodPopulation: ITT population, Last Observation Carried Forward imputation was applied
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum HAM-A Score is 56. Endpoint is last observed value during the 8 week treatment period.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=117 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=117 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=64 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=59 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in the Total HAM-A Score at Endpoint During the 8 Week Treatment Period
|
-17.3 Units on a scale
Standard Deviation 13.03
|
-14.3 Units on a scale
Standard Deviation 11.32
|
-13.6 Units on a scale
Standard Deviation 8.85
|
-11.5 Units on a scale
Standard Deviation 10.44
|
SECONDARY outcome
Timeframe: 1 weekPopulation: ITT population, but only patients with a non-missing value at timepoint are included in the analysis
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=112 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=109 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=63 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=57 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week
Response
|
39 participants
|
24 participants
|
22 participants
|
16 participants
|
|
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 1 Week
No Response
|
73 participants
|
85 participants
|
41 participants
|
41 participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: ITT population, but only patients with a non-missing value at timepoint are included in the analysis
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=108 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=103 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=61 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=53 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks
Response
|
48 participants
|
38 participants
|
30 participants
|
23 participants
|
|
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 2 Weeks
No Response
|
60 participants
|
65 participants
|
31 participants
|
30 participants
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: ITT population, but only patients with a non-missing value at timepoint are included in the analysis
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=101 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=92 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=58 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=52 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks
Response
|
56 participants
|
51 participants
|
33 participants
|
31 participants
|
|
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 3 Weeks
No Response
|
45 participants
|
41 participants
|
25 participants
|
21 participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: ITT population, but only patients with a non-missing value at timepoint are included in the analysis
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=97 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=90 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=54 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=48 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks
Response
|
58 participants
|
56 participants
|
37 participants
|
25 participants
|
|
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 4 Weeks
No Response
|
39 participants
|
34 participants
|
17 participants
|
23 participants
|
SECONDARY outcome
Timeframe: 5 weeksPopulation: ITT population, but only patients with a non-missing value at timepoint are included in the analysis
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=89 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=81 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=51 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=48 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks
Response
|
59 participants
|
51 participants
|
33 participants
|
30 participants
|
|
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 5 Weeks
Non Response
|
30 participants
|
30 participants
|
18 participants
|
18 participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: ITT population, but only patients with a non-missing value at timepoint are included in the analysis
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=87 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=81 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=47 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=47 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks
No Response
|
24 participants
|
25 participants
|
16 participants
|
15 participants
|
|
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 6 Weeks
Response
|
63 participants
|
56 participants
|
31 participants
|
32 participants
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: ITT population, but only patients with a non-missing value at timepoint are included in the analysis
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=83 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=82 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=53 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=49 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks
Response
|
60 participants
|
57 participants
|
37 participants
|
34 participants
|
|
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 7 Weeks
No Response
|
23 participants
|
25 participants
|
16 participants
|
15 participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: ITT population, but only patients with a non-missing value at timepoint are included in the analysis
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe).
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=84 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=84 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=53 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=47 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks
Response
|
61 participants
|
62 participants
|
38 participants
|
35 participants
|
|
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) After 8 Weeks
No Response
|
23 participants
|
22 participants
|
15 participants
|
12 participants
|
SECONDARY outcome
Timeframe: at endpoint during the 8 week treatment periodPopulation: ITT population, Last Observation Carried Forward imputation was applied
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Endpoint is last observed value during the 8 week treatment period.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=117 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=117 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=64 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=59 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period
Response
|
78 participants
|
74 participants
|
44 participants
|
40 participants
|
|
Clinical Response (Decrease From Baseline in Total HAM-A-score >=50%) at Endpoint During the 8 Week Treatment Period
No Response
|
39 participants
|
43 participants
|
20 participants
|
19 participants
|
SECONDARY outcome
Timeframe: Baseline and 2 weeksPopulation: ITT population, but only patients with non-missing values were included
The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table).
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=119 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=107 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=66 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=57 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks
Very much improved
|
6 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks
much improved
|
38 Participants
|
23 Participants
|
25 Participants
|
10 Participants
|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks
minimally improved
|
53 Participants
|
35 Participants
|
27 Participants
|
20 Participants
|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks
No change
|
17 Participants
|
40 Participants
|
9 Participants
|
18 Participants
|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks
Minimally worse
|
4 Participants
|
7 Participants
|
1 Participants
|
6 Participants
|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks
Much worse
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression Improvement (CGI-I) Score After 2 Weeks
Very much worse
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table).
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=107 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=99 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=60 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=46 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks
Very much improved
|
18 participants
|
5 participants
|
12 participants
|
1 participants
|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks
Much improved
|
40 participants
|
40 participants
|
26 participants
|
18 participants
|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks
Minimally improved
|
35 participants
|
23 participants
|
13 participants
|
17 participants
|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks
No change
|
7 participants
|
19 participants
|
7 participants
|
9 participants
|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks
Minimally worse
|
6 participants
|
9 participants
|
1 participants
|
1 participants
|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks
Much worse
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 4 Weeks
Very much worse
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table).
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=93 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=96 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=57 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=51 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks
No change
|
3 participants
|
19 participants
|
5 participants
|
4 participants
|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks
Very much improved
|
28 participants
|
27 participants
|
14 participants
|
12 participants
|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks
Much improved
|
44 participants
|
27 participants
|
25 participants
|
22 participants
|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks
Minimally improved
|
16 participants
|
19 participants
|
11 participants
|
13 participants
|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks
Minimally worse
|
2 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks
Much worse
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score After 8 Weeks
Very much worse
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and at endpoint during the 8 week treatment periodPopulation: ITT population, but only subjects with non-missing values have been included
The Clinical Global Impression Improvement (CGI-I) scale is a 7 point ordinal scale that assesses how the patient's illness has improved ranging from 'very much improved' to 'very much worse'(see definition of categories in results table). Endpoint is last observed value during the 8 week treatment period.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=122 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=113 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=66 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=59 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period
Very much improved
|
31 participants
|
27 participants
|
14 participants
|
12 participants
|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period
Much improved
|
47 participants
|
31 participants
|
29 participants
|
23 participants
|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period
Minimally improved
|
30 participants
|
24 participants
|
12 participants
|
16 participants
|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period
No change
|
7 participants
|
25 participants
|
8 participants
|
5 participants
|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period
Minimally worse
|
6 participants
|
2 participants
|
2 participants
|
2 participants
|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period
Much worse
|
1 participants
|
3 participants
|
1 participants
|
1 participants
|
|
Change in Severity of Illness From Baseline Using the Clinical Global Impression - Improvement (CGI-I) Score at Endpoint During the 8 Week Treatment Period
Very much worse
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 1 weekPopulation: ITT population, but only patients with non-missing values are included in the analysis
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=109 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=102 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=61 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=53 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week
Very much better
|
7 participants
|
0 participants
|
3 participants
|
0 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week
Much better
|
24 participants
|
5 participants
|
10 participants
|
7 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week
A little better
|
35 participants
|
40 participants
|
27 participants
|
9 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week
Unchanged
|
39 participants
|
46 participants
|
20 participants
|
31 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week
A little worse
|
2 participants
|
6 participants
|
1 participants
|
3 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week
Much worse
|
1 participants
|
5 participants
|
0 participants
|
2 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 1 Week
Very much worse
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=110 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=104 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=62 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=54 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks
Very much better
|
10 participants
|
2 participants
|
5 participants
|
4 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks
Much better
|
30 participants
|
16 participants
|
21 participants
|
7 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks
A little better
|
34 participants
|
38 participants
|
21 participants
|
20 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks
Unchanged
|
29 participants
|
37 participants
|
13 participants
|
17 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks
A little worse
|
3 participants
|
3 participants
|
0 participants
|
3 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks
Much worse
|
4 participants
|
5 participants
|
1 participants
|
2 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 2 Weeks
Very much worse
|
0 participants
|
3 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=107 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=95 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=61 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=53 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks
Very much better
|
22 participants
|
7 participants
|
10 participants
|
2 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks
Much better
|
23 participants
|
21 participants
|
21 participants
|
14 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks
A little better
|
33 participants
|
28 participants
|
16 participants
|
22 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks
Unchanged
|
24 participants
|
31 participants
|
12 participants
|
13 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks
A little worse
|
2 participants
|
3 participants
|
1 participants
|
0 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks
Much worse
|
1 participants
|
5 participants
|
1 participants
|
1 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 3 Weeks
Very much worse
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=102 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=93 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=57 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=49 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks
Very much better
|
18 participants
|
13 participants
|
13 participants
|
6 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks
Much better
|
38 participants
|
24 participants
|
19 participants
|
14 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks
A little better
|
26 participants
|
20 participants
|
16 participants
|
18 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks
Unchanged
|
14 participants
|
28 participants
|
5 participants
|
8 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks
A little worse
|
2 participants
|
4 participants
|
2 participants
|
1 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks
Much worse
|
2 participants
|
3 participants
|
2 participants
|
1 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 4 Weeks
Very much worse
|
2 participants
|
1 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 5 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=94 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=84 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=54 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=49 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks
Very much better
|
21 participants
|
10 participants
|
13 participants
|
5 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks
Much better
|
32 participants
|
27 participants
|
19 participants
|
20 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks
A little better
|
16 participants
|
19 participants
|
18 participants
|
10 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks
Unchanged
|
16 participants
|
19 participants
|
4 participants
|
12 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks
A little worse
|
3 participants
|
2 participants
|
0 participants
|
1 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks
Much worse
|
6 participants
|
6 participants
|
0 participants
|
0 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 5 Weeks
Very much worse
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=93 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=84 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=50 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=48 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks
Very much better
|
22 participants
|
16 participants
|
15 participants
|
6 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks
Much better
|
29 participants
|
24 participants
|
20 participants
|
15 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks
A little better
|
23 participants
|
17 participants
|
11 participants
|
16 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks
Unchanged
|
16 participants
|
18 participants
|
4 participants
|
8 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks
A little worse
|
2 participants
|
2 participants
|
0 participants
|
2 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks
Much worse
|
1 participants
|
5 participants
|
0 participants
|
0 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 6 Weeks
Very much worse
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=88 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=84 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=56 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=50 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks
Very much better
|
23 participants
|
21 participants
|
12 participants
|
8 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks
Much better
|
28 participants
|
24 participants
|
23 participants
|
23 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks
A little better
|
17 participants
|
17 participants
|
11 participants
|
7 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks
Unchanged
|
15 participants
|
18 participants
|
8 participants
|
9 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks
A little worse
|
3 participants
|
1 participants
|
2 participants
|
1 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks
Much worse
|
2 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 7 Weeks
Very much worse
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: ITT population, Last Observation Carried Forward imputation was applied
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables).
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=88 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=86 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=56 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=48 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks
Very much better
|
28 participants
|
23 participants
|
20 participants
|
13 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks
Much better
|
28 participants
|
22 participants
|
14 participants
|
13 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks
A little better
|
17 participants
|
21 participants
|
13 participants
|
12 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks
Unchanged
|
13 participants
|
16 participants
|
8 participants
|
7 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks
A little worse
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks
Much worse
|
0 participants
|
3 participants
|
0 participants
|
1 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score After 8 Weeks
Very much worse
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: at endpoint during the 8 week treatment periodPopulation: ITT population, Last Observation Carried Forward imputation was applied
The Patient Global Impression (PGI) scale is a 7 point ordinal scale that rates subject's assessment of treatment effect ranging from 'very much better' to 'very much worse' (see categories in results tables). Endpoint is last observed value during the 8 week treatment period.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=123 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=119 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=66 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=60 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period
Very much worse
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period
A little better
|
27 participants
|
30 participants
|
17 participants
|
14 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period
Unchanged
|
20 participants
|
30 participants
|
12 participants
|
11 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period
A little worse
|
3 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period
Much worse
|
3 participants
|
6 participants
|
1 participants
|
3 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period
Very much better
|
34 participants
|
25 participants
|
21 participants
|
14 participants
|
|
Subject's Assessment of Treatment Effect as Measured by the Patient Global Impression (PGI) Score at Endpoint During the 8 Week Treatment Period
Much better
|
36 participants
|
27 participants
|
14 participants
|
15 participants
|
SECONDARY outcome
Timeframe: Baseline and 1 weekPopulation: ITT population, but only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=112 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=109 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=63 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=57 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-insomnia Subscore After 1 Week
|
-0.9 Units on a scale
Standard Deviation 1.42
|
-0.6 Units on a scale
Standard Deviation 1.43
|
-1.0 Units on a scale
Standard Deviation 1.40
|
-0.5 Units on a scale
Standard Deviation 1.40
|
SECONDARY outcome
Timeframe: Baseline and 2 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=108 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=103 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=61 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=53 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-insomnia Subscore After 2 Weeks
|
-1.0 Units on a scale
Standard Deviation 1.49
|
-0.9 Units on a scale
Standard Deviation 1.40
|
-1.2 Units on a scale
Standard Deviation 1.50
|
-0.6 Units on a scale
Standard Deviation 1.50
|
SECONDARY outcome
Timeframe: Baseline and 3 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=101 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=92 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=58 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=52 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-insomnia Subscore After 3 Weeks
|
-1.2 Units on a scale
Standard Deviation 1.48
|
-1.1 Units on a scale
Standard Deviation 1.43
|
-1.4 Units on a scale
Standard Deviation 1.40
|
-1.2 Units on a scale
Standard Deviation 1.36
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=97 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=90 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=54 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=48 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-insomnia Subscore After 4 Weeks
|
-1.3 Units on a scale
Standard Deviation 1.65
|
-1.4 Units on a scale
Standard Deviation 1.47
|
-1.6 Units on a scale
Standard Deviation 1.34
|
-1.1 Units on a scale
Standard Deviation 1.42
|
SECONDARY outcome
Timeframe: Baseline and 5 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=89 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=81 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=51 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=48 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-insomnia Subscore After 5 Weeks
|
-1.3 Units on a scale
Standard Deviation 1.56
|
-1.4 Units on a scale
Standard Deviation 1.52
|
-1.5 Units on a scale
Standard Deviation 1.36
|
-1.1 Units on a scale
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=87 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=81 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=47 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=47 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-insomnia Subscore After 6 Weeks
|
-1.4 Units on a scale
Standard Deviation 1.64
|
-1.5 Units on a scale
Standard Deviation 1.52
|
-1.6 Units on a scale
Standard Deviation 1.25
|
-1.1 Units on a scale
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: Baseline and 7 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=83 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=82 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=53 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=49 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-insomnia Subscore After 7 Weeks
|
-1.5 Units on a scale
Standard Deviation 1.63
|
-1.4 Units on a scale
Standard Deviation 1.49
|
-1.6 Units on a scale
Standard Deviation 1.32
|
-1.2 Units on a scale
Standard Deviation 1.40
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=84 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=84 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=53 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=47 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-insomnia Subscore After 8 Weeks
|
-1.6 Units on a scale
Standard Deviation 1.57
|
-1.6 Units on a scale
Standard Deviation 1.41
|
-1.6 Units on a scale
Standard Deviation 1.33
|
-1.3 Units on a scale
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Baseline and at endpoint during the 8 week treatment periodPopulation: ITT population, Last Observation Carried Forward imputation was applied
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the insomnia subscore is 4. Endpoint is last observed value during the 8 week treatment period.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=117 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=117 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=64 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=59 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-insomnia Subscore at Endpoint During the 8 Week Treatment Period
|
-1.6 Units on a scale
Standard Deviation 1.53
|
-1.4 Units on a scale
Standard Deviation 1.49
|
-1.5 Units on a scale
Standard Deviation 1.38
|
-1.3 Units on a scale
Standard Deviation 1.51
|
SECONDARY outcome
Timeframe: Baseline and 1 weekPopulation: ITT population, but only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=112 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=109 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=63 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=57 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-psychic Factors Subscore After 1 Week
|
-4.9 Units on a scale
Standard Deviation 5.73
|
-2.9 Units on a scale
Standard Deviation 4.78
|
-4.5 Units on a scale
Standard Deviation 4.53
|
-3.3 Units on a scale
Standard Deviation 4.08
|
SECONDARY outcome
Timeframe: Baseline and 2 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=108 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=103 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=61 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=53 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-psychic Factors Subscore After 2 Weeks
|
-6.0 Units on a scale
Standard Deviation 5.97
|
-4.5 Units on a scale
Standard Deviation 4.88
|
-5.8 Units on a scale
Standard Deviation 5.23
|
-4.1 Units on a scale
Standard Deviation 4.53
|
SECONDARY outcome
Timeframe: Baseline and 3 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=101 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=92 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=58 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=52 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-psychic Factors Subscore After 3 Weeks
|
-7.3 Units on a scale
Standard Deviation 5.98
|
-6.8 Units on a scale
Standard Deviation 5.42
|
-6.4 Units on a scale
Standard Deviation 5.44
|
-6.1 Units on a scale
Standard Deviation 4.87
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=97 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=90 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=54 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=48 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-psychic Factors Subscore After 4 Weeks
|
-7.7 Units on a scale
Standard Deviation 5.95
|
-7.4 Units on a scale
Standard Deviation 5.57
|
-7.8 Units on a scale
Standard Deviation 5.14
|
-5.9 Units on a scale
Standard Deviation 4.80
|
SECONDARY outcome
Timeframe: Baseline and 5 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=89 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=81 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=51 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=48 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-psychic Factors Subscore After 5 Weeks
|
-8.7 Units on a scale
Standard Deviation 5.84
|
-7.7 Units on a scale
Standard Deviation 5.99
|
-7.9 Units on a scale
Standard Deviation 5.08
|
-6.8 Units on a scale
Standard Deviation 5.76
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=87 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=81 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=47 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=47 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-psychic Factors Subscore After 6 Weeks
|
-9.4 Units on a scale
Standard Deviation 5.84
|
-8.3 Units on a scale
Standard Deviation 5.66
|
-8.7 Units on a scale
Standard Deviation 4.81
|
-7.2 Units on a scale
Standard Deviation 5.82
|
SECONDARY outcome
Timeframe: Baseline and 7 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=83 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=82 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=53 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=49 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-psychic Factors Subscore After 7 Weeks
|
-9.6 Units on a scale
Standard Deviation 6.27
|
-8.4 Units on a scale
Standard Deviation 5.75
|
-8.1 Units on a scale
Standard Deviation 5.16
|
-7.6 Units on a scale
Standard Deviation 6.19
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=84 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=84 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=53 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=47 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-psychic Factors Subscore After 8 Weeks
|
-9.9 Units on a scale
Standard Deviation 6.63
|
-8.9 Units on a scale
Standard Deviation 5.13
|
-8.5 Units on a scale
Standard Deviation 4.91
|
-8.5 Units on a scale
Standard Deviation 5.51
|
SECONDARY outcome
Timeframe: Baseline and at endpoint during the 8 week treatment periodPopulation: ITT population, Last Observation Carried Forward imputation was applied
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the psychic factors subscore is 4. Endpoint is last observed value during the 8 week treatment period.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=117 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=117 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=64 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=59 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-psychic Factors Subscore at Endpoint During the 8 Week Treatment Period
|
-9.1 Units on a scale
Standard Deviation 6.58
|
-7.6 Units on a scale
Standard Deviation 5.82
|
-7.9 Units on a scale
Standard Deviation 5.19
|
-7.9 Units on a scale
Standard Deviation 5.81
|
SECONDARY outcome
Timeframe: Baseline and 1 weekPopulation: ITT population, but only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=112 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=109 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=63 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=57 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-somatic Subscore After 1 Week
|
-4.4 Units on a scale
Standard Deviation 6.95
|
-2.9 Units on a scale
Standard Deviation 5.80
|
-3.3 Units on a scale
Standard Deviation 4.46
|
-1.4 Units on a scale
Standard Deviation 5.43
|
SECONDARY outcome
Timeframe: Baseline and 2 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=108 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=103 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=61 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=53 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-somatic Subscore After 2 Weeks
|
-5.6 Units on a scale
Standard Deviation 6.31
|
-3.7 Units on a scale
Standard Deviation 6.18
|
-4.2 Units on a scale
Standard Deviation 5.52
|
-2.0 Units on a scale
Standard Deviation 6.05
|
SECONDARY outcome
Timeframe: Baseline and 3 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=101 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=92 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=58 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=52 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-somatic Subscore After 3 Weeks
|
-7.0 Units on a scale
Standard Deviation 7.03
|
-6.1 Units on a scale
Standard Deviation 7.55
|
-4.5 Units on a scale
Standard Deviation 5.85
|
-3.4 Units on a scale
Standard Deviation 6.27
|
SECONDARY outcome
Timeframe: Baseline and 4 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=97 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=90 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=54 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=48 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-somatic Subscore After 4 Weeks
|
-7.5 Units on a scale
Standard Deviation 6.96
|
-6.4 Units on a scale
Standard Deviation 6.50
|
-5.1 Units on a scale
Standard Deviation 5.95
|
-2.3 Units on a scale
Standard Deviation 5.71
|
SECONDARY outcome
Timeframe: Baseline and 5 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=89 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=81 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=51 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=48 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-somatic Subscore After 5 Weeks
|
-8.0 Units on a scale
Standard Deviation 7.21
|
-6.8 Units on a scale
Standard Deviation 7.14
|
-5.4 Units on a scale
Standard Deviation 5.31
|
-3.4 Units on a scale
Standard Deviation 6.95
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=87 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=81 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=47 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=47 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-somatic Subscore After 6 Weeks
|
-8.3 Units on a scale
Standard Deviation 7.41
|
-6.8 Units on a scale
Standard Deviation 7.32
|
-4.7 Units on a scale
Standard Deviation 4.83
|
-3.8 Units on a scale
Standard Deviation 6.19
|
SECONDARY outcome
Timeframe: Baseline and 7 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=83 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=82 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=53 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=49 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-somatic Subscore After 7 Weeks
|
-8.1 Units on a scale
Standard Deviation 7.74
|
7.2 Units on a scale
Standard Deviation 7.38
|
-5.2 Units on a scale
Standard Deviation 5.37
|
-3.7 Units on a scale
Standard Deviation 6.64
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: ITT population, but only subjects with non-missing values have been included
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=84 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=84 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=53 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=47 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-somatic Subscore After 8 Weeks
|
-8.6 Units on a scale
Standard Deviation 7.98
|
-7.7 Units on a scale
Standard Deviation 7.43
|
-5.5 Units on a scale
Standard Deviation 5.53
|
-3.8 Units on a scale
Standard Deviation 5.76
|
SECONDARY outcome
Timeframe: Baseline and at endpoint during the 8 week treatment periodPopulation: ITT population, Last Observation Carried Forward imputation was applied
The Hamilton Anxiety (HAM-A) Rating scale is a test of 14 items measuring the severity of anxiety symptoms. Each item is rated on a 5-point ordinal scale, ranging from 0 (not present) to 4 (severe). Maximum score of the somatic subscore is 4. Endpoint is last observed value during the 8 week treatment period.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=117 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=117 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=64 Participants
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=59 Participants
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Change From Baseline in HAM-A-somatic Subscore at Endpoint During the 8 Week Treatment Period
|
-8.2 Units on a scale
Standard Deviation 7.86
|
-6.7 Units on a scale
Standard Deviation 7.18
|
-5.6 Units on a scale
Standard Deviation 5.72
|
-3.6 Units on a scale
Standard Deviation 6.24
|
SECONDARY outcome
Timeframe: 1 weekPopulation: ITT population, but only patients with non-missing assessments were included
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=118 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=112 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 1 Week
Any panic attack
|
76 participants
|
69 participants
|
—
|
—
|
|
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 1 Week
No panic attack
|
42 participants
|
43 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: ITT population, but only subjects with non-missing values have been included
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=114 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=106 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 2 Weeks
Any panic attack
|
60 participants
|
60 participants
|
—
|
—
|
|
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 2 Weeks
No panic attack
|
54 participants
|
46 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: ITT population, but only subjects with non-missing values have been included
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=107 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=95 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 3 Weeks
Any panic attack
|
41 participants
|
37 participants
|
—
|
—
|
|
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 3 Weeks
No panic attack
|
66 participants
|
58 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: ITT population, but only subjects with non-missing values have been included
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=103 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=93 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 4 Weeks
Any panic attack
|
43 participants
|
43 participants
|
—
|
—
|
|
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 4 Weeks
No panic attack
|
60 participants
|
50 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 weeksPopulation: ITT population, but only subjects with non-missing values have been included
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=95 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=84 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 5 Weeks
Any panic attack
|
35 participants
|
40 participants
|
—
|
—
|
|
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 5 Weeks
No panic attack
|
60 participants
|
44 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: ITT population, but only subjects with non-missing values have been included
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=93 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=84 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 6 Weeks
Any panic attack
|
36 participants
|
33 participants
|
—
|
—
|
|
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 6 Weeks
No panic attack
|
57 participants
|
51 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 weeksPopulation: ITT population, but only subjects with non-missing values have been included
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=88 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=85 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 7 Weeks
Any panic attack
|
32 participants
|
31 participants
|
—
|
—
|
|
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 7 Weeks
No panic attack
|
56 participants
|
54 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: ITT population, but only subjects with non-missing values have been included
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=88 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=87 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 8 Weeks
Any panic attack
|
26 participants
|
32 participants
|
—
|
—
|
|
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) After 8 Weeks
No panic attack
|
62 participants
|
55 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: at endpoint during the 8 week treatment periodPopulation: ITT population, Last Observation Carried Forward imputation was applied
Endpoint is last observed value during the 8 week treatment period.
Outcome measures
| Measure |
Panic: Niravam+SSRI/SNRI
n=123 Participants
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=120 Participants
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) at Endpoint During the 8 Week Treatment Period
Any panic attack
|
47 participants
|
50 participants
|
—
|
—
|
|
Presence of Any Panic Attack(s) (for Subjects With Panic Disorder Only) at Endpoint During the 8 Week Treatment Period
No panic attack
|
76 participants
|
70 participants
|
—
|
—
|
Adverse Events
Panic: Niravam+SSRI/SNRI
Panic: SSRI/SNRI Alone
GAD : Niravam+SSRI/SNRI
GAD: SSRI/SNRI Alone
Serious adverse events
| Measure |
Panic: Niravam+SSRI/SNRI
n=137 participants at risk
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=135 participants at risk
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=71 participants at risk
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=71 participants at risk
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Infections and infestations
Bronchitis acute
|
0.00%
0/137
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.74%
1/135
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/71
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/71
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
|
Infections and infestations
Kidney infection
|
0.73%
1/137
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/135
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/71
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/71
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
|
Infections and infestations
Postoperative infection
|
0.73%
1/137
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/135
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/71
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/71
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
|
Injury, poisoning and procedural complications
Multiple drug overdose
|
0.73%
1/137
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/135
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/71
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/71
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
|
Renal and urinary disorders
Renal Failure
|
0.73%
1/137
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/135
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/71
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/71
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
|
Vascular disorders
Temporal Arteritis
|
0.00%
0/137
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.74%
1/135
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/71
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/71
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/137
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/135
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/71
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
1.4%
1/71
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/137
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/135
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/71
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
1.4%
1/71
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
|
Infections and infestations
Sternitis
|
0.73%
1/137
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/135
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/71
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/71
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
|
Renal and urinary disorders
Bacterial Pyelonephritis
|
0.73%
1/137
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/135
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/71
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/71
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
Other adverse events
| Measure |
Panic: Niravam+SSRI/SNRI
n=137 participants at risk
Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
|
Panic: SSRI/SNRI Alone
n=135 participants at risk
Panic Disorder: Newly prescribed SSRI or SNRI alone
|
GAD : Niravam+SSRI/SNRI
n=71 participants at risk
Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
|
GAD: SSRI/SNRI Alone
n=71 participants at risk
Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
5.8%
8/137
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
3.7%
5/135
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
5.6%
4/71
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
5.6%
4/71
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
|
Nervous system disorders
Somnolence
|
6.6%
9/137
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
1.5%
2/135
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
4.2%
3/71
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
0.00%
0/71
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
|
General disorders
Fatigue
|
2.2%
3/137
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
2.2%
3/135
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
7.0%
5/71
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
1.4%
1/71
The safety population consists of 414 subjects that received at least one dose of SSRI/SNRI and/or Niravam.
|
Additional Information
UCB Clinical Trial Call Center
UCB Pharma
Results disclosure agreements
- Principal investigator is a sponsor employee UCB has \> 60 days but \<= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER