Trial Outcomes & Findings for Sustaining Remission of Psychotic Depression (NCT NCT01427608)
NCT ID: NCT01427608
Last Updated: 2019-03-05
Results Overview
Relapse criteria include at least one of the following: 1)Structured Clinical Interview for Diagnostic Statistical Manual #4 Trade Revision (DSM-IV-TR) Axis 1 Disorders (SCID) symptoms of major depression maintained over two weeks 2)17-item Hamilton Depression Rating Scale score of \>17 maintained for more than one week + a mean increase of 5 points from entry into randomized phase 3)Re-emergence of psychosis for more than one week, with a SADS (Schedule for Affective Disorders and Schizophrenia) score of \>2 on delusion or hallucination severity items 4)Significant clinical worsening defined as either emergence of high-risk of suicide, and/or development of mania for greater than one week, and/or psychiatric hospitalization.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
269 participants
Primary outcome timeframe
From entry into randomized phase (baseline) and 36 weeks or earlier relapse
Results posted on
2019-03-05
Participant Flow
269 participants were enrolled in the open-label phase. However, only 126 participants were eligible and consented to participate in the RCT phase. Reasons for not being eligible for the RCT phase included failure to achive remission criteria, discontinuation of treatment prior to the RCT, or decision by the participant not to consent to the RCT.
Participant milestones
| Measure |
Sertraline + Olanzapine
Randomized to continue with sertraline and olanzapine under double-blind conditions
|
Sertraline + Placebo
Randomized to continue with sertraline and substitute placebo for olanzapine under double-blind conditions
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
62
|
|
Overall Study
COMPLETED
|
43
|
24
|
|
Overall Study
NOT COMPLETED
|
21
|
38
|
Reasons for withdrawal
| Measure |
Sertraline + Olanzapine
Randomized to continue with sertraline and olanzapine under double-blind conditions
|
Sertraline + Placebo
Randomized to continue with sertraline and substitute placebo for olanzapine under double-blind conditions
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
3
|
|
Overall Study
Relapsed-all cause
|
13
|
34
|
|
Overall Study
Events not attributed to study meds
|
0
|
1
|
Baseline Characteristics
Sustaining Remission of Psychotic Depression
Baseline characteristics by cohort
| Measure |
Sertraline + Olanzapine
n=64 Participants
Randomized to continue with sertraline and olanzapine under double-blind conditions
|
Sertraline + Placebo
n=62 Participants
Randomized to continue with sertraline and substitute placebo for olanzapine under double-blind conditions
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Age, Continuous
|
55.0 years
STANDARD_DEVIATION 15.1 • n=99 Participants
|
55.7 years
STANDARD_DEVIATION 14.9 • n=107 Participants
|
55.3 years
STANDARD_DEVIATION 14.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
111 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
103 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
24 participants
n=99 Participants
|
23 participants
n=107 Participants
|
47 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=99 Participants
|
39 participants
n=107 Participants
|
79 participants
n=206 Participants
|
|
Hamilton Depression Rating Scale 17-Item Total Score
|
5.3 units on a scale
STANDARD_DEVIATION 3.6 • n=99 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 3.6 • n=107 Participants
|
5.5 units on a scale
STANDARD_DEVIATION 3.6 • n=206 Participants
|
|
Weight
|
178.6 pounds
STANDARD_DEVIATION 39.4 • n=99 Participants
|
182.5 pounds
STANDARD_DEVIATION 39.8 • n=107 Participants
|
180.5 pounds
STANDARD_DEVIATION 39.5 • n=206 Participants
|
|
Total Cholesterol level
|
209.0 mg/dL
STANDARD_DEVIATION 51.3 • n=99 Participants
|
220.4 mg/dL
STANDARD_DEVIATION 46.8 • n=107 Participants
|
214.7 mg/dL
STANDARD_DEVIATION 49.3 • n=206 Participants
|
|
Triglycerides
|
134 mg/dL
n=99 Participants
|
121 mg/dL
n=107 Participants
|
127 mg/dL
n=206 Participants
|
PRIMARY outcome
Timeframe: From entry into randomized phase (baseline) and 36 weeks or earlier relapseRelapse criteria include at least one of the following: 1)Structured Clinical Interview for Diagnostic Statistical Manual #4 Trade Revision (DSM-IV-TR) Axis 1 Disorders (SCID) symptoms of major depression maintained over two weeks 2)17-item Hamilton Depression Rating Scale score of \>17 maintained for more than one week + a mean increase of 5 points from entry into randomized phase 3)Re-emergence of psychosis for more than one week, with a SADS (Schedule for Affective Disorders and Schizophrenia) score of \>2 on delusion or hallucination severity items 4)Significant clinical worsening defined as either emergence of high-risk of suicide, and/or development of mania for greater than one week, and/or psychiatric hospitalization.
Outcome measures
| Measure |
Sertraline + Olanzapine
n=64 Participants
Randomized to continue with sertraline and olanzapine under double-blind conditions
|
Sertraline + Placebo
n=62 Participants
Randomized to continue with sertraline and substitute placebo for olanzapine under double-blind conditions
|
|---|---|---|
|
Number of Subjects at Risk of Relapse During the Randomized Phase.
|
13 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: From entry into randomized phase (baseline) and 36 weeksChange in weight from entry into randomized phase (baseline) and 36 weeks.
Outcome measures
| Measure |
Sertraline + Olanzapine
n=64 Participants
Randomized to continue with sertraline and olanzapine under double-blind conditions
|
Sertraline + Placebo
n=62 Participants
Randomized to continue with sertraline and substitute placebo for olanzapine under double-blind conditions
|
|---|---|---|
|
Changes in Metabolic Measures: Weight
|
5.70 pounds
Interval 3.3 to 8.11
|
-3.11 pounds
Interval -5.41 to -0.81
|
SECONDARY outcome
Timeframe: From entry into randomized phase (baseline) and 36 weeksChange in cholesterol from entry into randomized phase (baseline) and 36 weeks.
Outcome measures
| Measure |
Sertraline + Olanzapine
n=64 Participants
Randomized to continue with sertraline and olanzapine under double-blind conditions
|
Sertraline + Placebo
n=62 Participants
Randomized to continue with sertraline and substitute placebo for olanzapine under double-blind conditions
|
|---|---|---|
|
Changes in Metabolic Measure: Cholesterol
|
-0.46 mg/dL
Interval -14.9 to 5.57
|
-22.28 mg/dL
Interval -32.71 to -11.86
|
SECONDARY outcome
Timeframe: From entry into randomized phase (baseline) and 36 weeksChange in triglycerides from entry into randomized phase (baseline) and 36 weeks.
Outcome measures
| Measure |
Sertraline + Olanzapine
n=64 Participants
Randomized to continue with sertraline and olanzapine under double-blind conditions
|
Sertraline + Placebo
n=62 Participants
Randomized to continue with sertraline and substitute placebo for olanzapine under double-blind conditions
|
|---|---|---|
|
Changes in Metabolic Measures: Triglycerides
|
-3.85 mg/dL
Interval -31.68 to 23.99
|
-18.18 mg/dL
Interval -30.05 to -6.31
|
Adverse Events
Sertraline + Olanzapine
Serious events: 11 serious events
Other events: 29 other events
Deaths: 1 deaths
Sertraline + Placebo
Serious events: 12 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sertraline + Olanzapine
n=64 participants at risk
Randomized to continue with sertraline and olanzapine under double-blind conditions
|
Sertraline + Placebo
n=62 participants at risk
Randomized to continue with sertraline and substitute placebo for olanzapine under double-blind conditions
|
|---|---|---|
|
Surgical and medical procedures
Hospitalisation
|
17.2%
11/64 • Number of events 11 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
19.4%
12/62 • Number of events 12 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
Other adverse events
| Measure |
Sertraline + Olanzapine
n=64 participants at risk
Randomized to continue with sertraline and olanzapine under double-blind conditions
|
Sertraline + Placebo
n=62 participants at risk
Randomized to continue with sertraline and substitute placebo for olanzapine under double-blind conditions
|
|---|---|---|
|
Psychiatric disorders
Abnormal dreams
|
1.6%
1/64 • Number of events 2 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
1.6%
1/62 • Number of events 1 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/64 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
1.6%
1/62 • Number of events 1 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
|
Psychiatric disorders
Depression
|
1.6%
1/64 • Number of events 1 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
0.00%
0/62 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
4/64 • Number of events 4 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
1.6%
1/62 • Number of events 2 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
|
Nervous system disorders
Dizziness postural
|
7.8%
5/64 • Number of events 5 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
3.2%
2/62 • Number of events 2 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/64 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
1.6%
1/62 • Number of events 1 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
|
General disorders
Fatigue
|
3.1%
2/64 • Number of events 2 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
1.6%
1/62 • Number of events 1 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
|
Nervous system disorders
Headache
|
4.7%
3/64 • Number of events 3 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
1.6%
1/62 • Number of events 1 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.6%
1/64 • Number of events 1 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
3.2%
2/62 • Number of events 2 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
|
Nervous system disorders
Hypersomnia
|
3.1%
2/64 • Number of events 2 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
4.8%
3/62 • Number of events 3 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
|
Psychiatric disorders
Indifference
|
1.6%
1/64 • Number of events 1 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
0.00%
0/62 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
|
Psychiatric disorders
Insomnia
|
3.1%
2/64 • Number of events 2 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
6.5%
4/62 • Number of events 4 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
|
Psychiatric disorders
Libido decreased
|
6.2%
4/64 • Number of events 4 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
0.00%
0/62 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.6%
1/64 • Number of events 1 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
0.00%
0/62 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
|
Gastrointestinal disorders
Nausea
|
3.1%
2/64 • Number of events 2 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
6.5%
4/62 • Number of events 5 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
|
Renal and urinary disorders
Polyuria
|
1.6%
1/64 • Number of events 1 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
0.00%
0/62 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/64 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
1.6%
1/62 • Number of events 1 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.1%
2/64 • Number of events 2 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
0.00%
0/62 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
|
Nervous system disorders
Somnolence
|
6.2%
4/64 • Number of events 5 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
3.2%
2/62 • Number of events 2 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
|
Psychiatric disorders
Tension
|
4.7%
3/64 • Number of events 3 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
0.00%
0/62 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
|
Infections and infestations
Urinary tract infection
|
1.6%
1/64 • Number of events 1 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
0.00%
0/62 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
|
Investigations
Weight decreased
|
4.7%
3/64 • Number of events 5 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
4.8%
3/62 • Number of events 3 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
|
Investigations
Weight increased
|
14.1%
9/64 • Number of events 11 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
4.8%
3/62 • Number of events 3 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
|
Renal and urinary disorders
Pollakiuria
|
1.6%
1/64 • Number of events 1 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
0.00%
0/62 • 36 Weeks of RCT Phase
Are based on items of the Udvalg for Kliniske Undersogelser Side effect scale (UKU), based on the following system: 1) Items with an increase of ≥2 points from baseline and items rated as a 3 on the UKU that were rated \<3 at baseline. Exceptions include the following items: 35=Weight Gain, 36= Weight Loss. 2) Weight gain and weight loss AEs were determined by the following definitions: a. weight gain of \>7% from pre-morbid weight, b. weight loss of \>7% from pre-morbid weight in the RCT phase.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place