Trial Outcomes & Findings for PH94B in the Treatment of Adjustment Disorder With Anxiety (NCT NCT04404192)
NCT ID: NCT04404192
Last Updated: 2026-02-05
Results Overview
Least squares mean change from baseline to Visit 6 in anxiety level as measured by the HAM-A at the end of the 4-week treatment period. The HAM-A questionnaire consists of 14 items, each scored on a 5-point scale (0="Not present", 1="Mild", 2="Moderate", 3="Severe", 4="Very severe. The HAM-A total score is calculated as the sum of the 14 individual scores, ranging from 0 to 56 where \<17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe. Higher total scores indicate more severe disease.
COMPLETED
PHASE2
41 participants
28 days
2026-02-05
Participant Flow
Participant milestones
| Measure |
PH94B
PH94B Nasal Spray - 3.2 micrograms four times a day for 28 days
|
Placebo
Placebo Nasal Spray - four times a day for 28 days
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
22
|
|
Overall Study
COMPLETED
|
15
|
19
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
PH94B
PH94B Nasal Spray - 3.2 micrograms four times a day for 28 days
|
Placebo
Placebo Nasal Spray - four times a day for 28 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Missed 2 or more consecutive visits during 4-week treatment period
|
1
|
0
|
Baseline Characteristics
PH94B in the Treatment of Adjustment Disorder With Anxiety
Baseline characteristics by cohort
| Measure |
PH94B
n=19 Participants
PH94B Nasal Spray - 3.2 micrograms four times a day for 28 days
|
Placebo
n=22 Participants
Placebo Nasal Spray - four times a day for 28 days
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=41 Participants
|
19 Participants
n=1581 Participants
|
36 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=41 Participants
|
20 Participants
n=1581 Participants
|
39 Participants
n=4626 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Age, Continuous
|
35.7 years
STANDARD_DEVIATION 12.74 • n=41 Participants
|
41.5 years
STANDARD_DEVIATION 13.00 • n=1581 Participants
|
38.8 years
STANDARD_DEVIATION 13.06 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=41 Participants
|
11 Participants
n=1581 Participants
|
17 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=41 Participants
|
11 Participants
n=1581 Participants
|
24 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
8 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=41 Participants
|
18 Participants
n=1581 Participants
|
33 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=41 Participants
|
22 participants
n=1581 Participants
|
41 participants
n=4626 Participants
|
|
Hamilton Anxiety Scale (HAM-A) Total Score
|
23.7 score on a scale
STANDARD_DEVIATION 3.32 • n=41 Participants
|
23.1 score on a scale
STANDARD_DEVIATION 2.64 • n=1581 Participants
|
23.4 score on a scale
STANDARD_DEVIATION 2.95 • n=4626 Participants
|
PRIMARY outcome
Timeframe: 28 daysLeast squares mean change from baseline to Visit 6 in anxiety level as measured by the HAM-A at the end of the 4-week treatment period. The HAM-A questionnaire consists of 14 items, each scored on a 5-point scale (0="Not present", 1="Mild", 2="Moderate", 3="Severe", 4="Very severe. The HAM-A total score is calculated as the sum of the 14 individual scores, ranging from 0 to 56 where \<17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe. Higher total scores indicate more severe disease.
Outcome measures
| Measure |
PH94B
n=19 Participants
PH94B Nasal Spray - 3.2 micrograms four times a day for 28 days
|
Placebo
n=22 Participants
Placebo Nasal Spray - four times a day for 28 days
|
|---|---|---|
|
Hamilton Anxiety Scale (HAM-A) Score
|
-12.5 score on a scale
Standard Error 1.31
|
-12.6 score on a scale
Standard Error 1.22
|
SECONDARY outcome
Timeframe: 28 daysThe CGI-I scale is a clinician-rated scale to assess illness improvement. The CGI-I scale includes one item scored from 1 (Very much less anxious) to 7 (Very much more anxious) with 4 being no change. Subjects are considered CGI-I responders with scores of 1 (Very much less anxious) or 2 (Much less anxious).
Outcome measures
| Measure |
PH94B
n=19 Participants
PH94B Nasal Spray - 3.2 micrograms four times a day for 28 days
|
Placebo
n=22 Participants
Placebo Nasal Spray - four times a day for 28 days
|
|---|---|---|
|
Percentage of Participants With Clinical Global Impression - Improvement Rating (CGI-I) Response
|
12 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 28 daysThe PGI-C is a self-administered instrument that measures change in subjects' overall improvement with treatment on a scale where 1= "very much improved" and 7= "very much worse". Values for comparison were the proportion of "responders" in each group, defined as subjects receiving scores of 1 (very much improved) or 2 (much improved) at the end of treatment.
Outcome measures
| Measure |
PH94B
n=19 Participants
PH94B Nasal Spray - 3.2 micrograms four times a day for 28 days
|
Placebo
n=22 Participants
Placebo Nasal Spray - four times a day for 28 days
|
|---|---|---|
|
Percentage of Participants With Patient Global Impression of Change (PGI-C) Response
|
8 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 28 daysLeast squares mean change from baseline to Visit 6 in ADNM total score. THE ADNM consists of 18-item stressful life checklist and a list of 20 statements about which reactions these types of events can trigger. Subjects are asked to indicate of how often the statements apply on a 4-point scale (1= "never", 2= "rarely", 3= "sometimes", 4= "often"). ADNM total score is calculated as the sum of the 20 frequency scores. Higher total scores indicate more severe disease.
Outcome measures
| Measure |
PH94B
n=19 Participants
PH94B Nasal Spray - 3.2 micrograms four times a day for 28 days
|
Placebo
n=22 Participants
Placebo Nasal Spray - four times a day for 28 days
|
|---|---|---|
|
Adjustment Disorder New Module Scale (ADNM) Score
|
-9.9 score on a scale
Standard Error 2.19
|
-12.1 score on a scale
Standard Error 2.13
|
SECONDARY outcome
Timeframe: 28 daysLeast squares mean change from baseline to Visit 6 in IADQ total score. The preoccupation, failure to adapt, and functional impairment subscale items are scored on a 5-point scale (0="Not at all", 1="A little bit", 2="Moderately", 3="Quite a bit", and 4="Extremely"). The IADQ total score is calculated as the sum of the 6 preoccupation and failure to adapt items. Higher total scores indicate more severe disease.
Outcome measures
| Measure |
PH94B
n=19 Participants
PH94B Nasal Spray - 3.2 micrograms four times a day for 28 days
|
Placebo
n=22 Participants
Placebo Nasal Spray - four times a day for 28 days
|
|---|---|---|
|
International Adjustment Disorder Questionnaire (IADQ) Score
|
-9.0 score on a scale
Standard Error 1.49
|
-11.4 score on a scale
Standard Error 1.45
|
Adverse Events
PH94B
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PH94B
n=19 participants at risk
PH94B Nasal Spray - 3.2 micrograms four times a day for 28 days
|
Placebo
n=22 participants at risk
Placebo Nasal Spray - four times a day for 28 days
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
5.3%
1/19 • 28 days
|
0.00%
0/22 • 28 days
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/19 • 28 days
|
4.5%
1/22 • 28 days
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/19 • 28 days
|
4.5%
1/22 • 28 days
|
|
Nervous system disorders
Dizziness
|
5.3%
1/19 • 28 days
|
4.5%
1/22 • 28 days
|
|
Nervous system disorders
Disturbance in attention
|
5.3%
1/19 • 28 days
|
0.00%
0/22 • 28 days
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • 28 days
|
4.5%
1/22 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discomfort
|
5.3%
1/19 • 28 days
|
0.00%
0/22 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Dryness
|
5.3%
1/19 • 28 days
|
0.00%
0/22 • 28 days
|
|
General disorders
Fatigue
|
5.3%
1/19 • 28 days
|
4.5%
1/22 • 28 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/19 • 28 days
|
4.5%
1/22 • 28 days
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/19 • 28 days
|
4.5%
1/22 • 28 days
|
|
Psychiatric disorders
Insomnia
|
5.3%
1/19 • 28 days
|
4.5%
1/22 • 28 days
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/19 • 28 days
|
4.5%
1/22 • 28 days
|
|
Psychiatric disorders
Change in sustained attention
|
0.00%
0/19 • 28 days
|
4.5%
1/22 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/19 • 28 days
|
4.5%
1/22 • 28 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/19 • 28 days
|
4.5%
1/22 • 28 days
|
|
Infections and infestations
COVID-19
|
5.3%
1/19 • 28 days
|
4.5%
1/22 • 28 days
|
|
Infections and infestations
Gastroenteritis
|
5.3%
1/19 • 28 days
|
0.00%
0/22 • 28 days
|
|
Eye disorders
Photophobia
|
0.00%
0/19 • 28 days
|
4.5%
1/22 • 28 days
|
|
Eye disorders
Vision blurred
|
5.3%
1/19 • 28 days
|
0.00%
0/22 • 28 days
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/19 • 28 days
|
4.5%
1/22 • 28 days
|
|
Injury, poisoning and procedural complications
Oral contusion
|
0.00%
0/19 • 28 days
|
4.5%
1/22 • 28 days
|
|
Injury, poisoning and procedural complications
Rib fracture
|
5.3%
1/19 • 28 days
|
0.00%
0/22 • 28 days
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/19 • 28 days
|
4.5%
1/22 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/19 • 28 days
|
4.5%
1/22 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/19 • 28 days
|
4.5%
1/22 • 28 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/19 • 28 days
|
4.5%
1/22 • 28 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.3%
1/19 • 28 days
|
0.00%
0/22 • 28 days
|
|
Nervous system disorders
Headache
|
15.8%
3/19 • 28 days
|
9.1%
2/22 • 28 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place