Trial Outcomes & Findings for Sequential Therapy for the Treatment of Severe Bipolar Depression. (NCT NCT02974010)
NCT ID: NCT02974010
Last Updated: 2021-05-25
Results Overview
The study will measure the difference on BISS-derived MADRS score between NRX-101 and lurasidone (comparator) groups. The Bipolar Inventory of Symptom Scale (BISS) is a validated 42-item clinician-rated scale (21 items each for the depression and mania subscales) in which each item is rated on a 0-4 severity scale where higher values indicate worse severity. BISS-derived MADRS (BDM): MADRS is a 10-item clinician-rated scale, with each item rated on a 0-6 severity scale, where a higher number indicates worse severity. Responses to each question are equally weighted and summed. The BDM has a minimum score of 0 and a maximum of 40, where higher scores indicate a worse severity, therefore decreases in average BDM are considered a better outcome. Data are presented as mean change from baseline (end of stage 1, Day 1) using LOCF
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Day 42
Results posted on
2021-05-25
Participant Flow
Participant milestones
| Measure |
Ketamine Followed by NRX-101
NRX-101 is a fixed dose combination of d-cycloserine and lurasidone
NRX-101 Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions
Ketamine Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
|
Ketamine Followed by Lurasidone
Lurasidone will be administered in the same dosages as the lurasidone component of NRX-101
Lurasidone Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions
Ketamine Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
|
Saline Followed by NRX-101
Lurasidone will be administered in the same dosages as the lurasidone component of NRX-101
Lurasidone Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions
Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
|
Saline Followed by Lurasidone
Lurasidone will be administered in the same dosages as the lurasidone component of NRX-101
Lurasidone Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions
Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
5
|
4
|
1
|
|
Overall Study
COMPLETED
|
6
|
2
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
2
|
0
|
Reasons for withdrawal
| Measure |
Ketamine Followed by NRX-101
NRX-101 is a fixed dose combination of d-cycloserine and lurasidone
NRX-101 Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions
Ketamine Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
|
Ketamine Followed by Lurasidone
Lurasidone will be administered in the same dosages as the lurasidone component of NRX-101
Lurasidone Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions
Ketamine Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
|
Saline Followed by NRX-101
Lurasidone will be administered in the same dosages as the lurasidone component of NRX-101
Lurasidone Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions
Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
|
Saline Followed by Lurasidone
Lurasidone will be administered in the same dosages as the lurasidone component of NRX-101
Lurasidone Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions
Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
|
Overall Study
Completed day 42 but did not return for day 70
|
1
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Sequential Therapy for the Treatment of Severe Bipolar Depression.
Baseline characteristics by cohort
| Measure |
Ketamine Followed by NRX-101
n=12 Participants
NRX-101 is a fixed-dose combination of d-cycloserine and lurasidone
NRX-101 Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions
Ketamine Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
|
Ketamine Followed by Lurasidone
n=5 Participants
Lurasidone will be administered in the same dosages as the lurasidone component of NRX-101
Lurasidone Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions
Ketamine Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
|
Saline Followed by NRX-101
n=4 Participants
Lurasidone will be administered in the same dosages as the lurasidone component of NRX-101
Lurasidone Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions
Ketamine Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
|
Saline Followed by Lurasidone
n=1 Participants
Lurasidone will be administered in the same dosages as the lurasidone component of NRX-101
Lurasidone Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions
Ketamine Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33.9 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
49 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
41 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
54 years
STANDARD_DEVIATION 0 • n=4 Participants
|
39.5 years
STANDARD_DEVIATION 11.43 • n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
1 participants
n=4 Participants
|
22 participants
n=21 Participants
|
|
Columbia Suicide Severity Rating Scale (CSSRS)
CSSRS = 1
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Columbia Suicide Severity Rating Scale (CSSRS)
CSSRS = 2
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Columbia Suicide Severity Rating Scale (CSSRS)
CSSRS =3
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
|
Columbia Suicide Severity Rating Scale (CSSRS)
CSSRS =4
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Columbia Suicide Severity Rating Scale (CSSRS)
CSSRS = 5
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
1 participants
n=4 Participants
|
19 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 42Population: Last Observation Carrier Forward
The study will measure the difference on BISS-derived MADRS score between NRX-101 and lurasidone (comparator) groups. The Bipolar Inventory of Symptom Scale (BISS) is a validated 42-item clinician-rated scale (21 items each for the depression and mania subscales) in which each item is rated on a 0-4 severity scale where higher values indicate worse severity. BISS-derived MADRS (BDM): MADRS is a 10-item clinician-rated scale, with each item rated on a 0-6 severity scale, where a higher number indicates worse severity. Responses to each question are equally weighted and summed. The BDM has a minimum score of 0 and a maximum of 40, where higher scores indicate a worse severity, therefore decreases in average BDM are considered a better outcome. Data are presented as mean change from baseline (end of stage 1, Day 1) using LOCF
Outcome measures
| Measure |
Ketamine Followed by NRX-101
n=12 Participants
NRX-101 is a fixed-dose combination of d-cycloserine and lurasidone
NRX-101 Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions
Ketamine Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
|
Ketamine Followed by Lurasidone
n=5 Participants
Lurasidone will be administered in the same dosages as the lurasidone component of NRX-101
Lurasidone Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions
Ketamine Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
|
Saline Followed by NRX-101
n=4 Participants
Saline (stage 1) followed by NRX-101 (stage 2)
|
Saline Followed by Lurasidone
n=1 Participants
Saline (stage 1) followed by lurasidone (stage 2)
|
|---|---|---|---|---|
|
BDM Score (BISS-derived MADRS) Change From Baseline at Day 42
Day 28
|
3.5 score on a scale
Standard Error 1.91
|
11.2 score on a scale
Standard Error 2.95
|
1.69 score on a scale
Standard Error 7.34
|
0 score on a scale
Standard Error 0
|
|
BDM Score (BISS-derived MADRS) Change From Baseline at Day 42
Day 2
|
3.3 score on a scale
Standard Error 1.95
|
2.4 score on a scale
Standard Error 2.95
|
-1.06 score on a scale
Standard Error 3.81
|
0 score on a scale
Standard Error 0
|
|
BDM Score (BISS-derived MADRS) Change From Baseline at Day 42
Day 7
|
2.0 score on a scale
Standard Error 1.91
|
4.8 score on a scale
Standard Error 2.95
|
-0.5 score on a scale
Standard Error 3.74
|
0 score on a scale
Standard Error 0
|
|
BDM Score (BISS-derived MADRS) Change From Baseline at Day 42
Day 14
|
2.2 score on a scale
Standard Error 1.91
|
11.4 score on a scale
Standard Error 2.95
|
0.31 score on a scale
Standard Error 4.0
|
0 score on a scale
Standard Error 0
|
|
BDM Score (BISS-derived MADRS) Change From Baseline at Day 42
Day 21
|
4.5 score on a scale
Standard Error 1.91
|
10.0 score on a scale
Standard Error 2.95
|
1.0 score on a scale
Standard Error 5.72
|
0 score on a scale
Standard Error 0
|
|
BDM Score (BISS-derived MADRS) Change From Baseline at Day 42
Day 35
|
2.8 score on a scale
Standard Error 1.91
|
10.8 score on a scale
Standard Error 2.95
|
1.75 score on a scale
Standard Error 8.43
|
0 score on a scale
Standard Error 0
|
|
BDM Score (BISS-derived MADRS) Change From Baseline at Day 42
Day 42
|
3.7 score on a scale
Standard Error 1.91
|
11.0 score on a scale
Standard Error 2.95
|
0.38 score on a scale
Standard Error 5.77
|
0 score on a scale
Standard Error 0
|
Adverse Events
Ketamine Followed by NRX-101
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Ketamine Followed by Lurasidone
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Saline Followed by NRX-101
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Saline Followed by Lurasidone
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ketamine Followed by NRX-101
n=12 participants at risk
NRX-101 is a fixed-dose combination of d-cycloserine and lurasidone
NRX-101 Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions
Ketamine Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
|
Ketamine Followed by Lurasidone
n=5 participants at risk
Lurasidone will be administered in the same dosages as the lurasidone component of NRX-101
Lurasidone Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions
Ketamine Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
|
Saline Followed by NRX-101
n=4 participants at risk
Lurasidone will be administered in the same dosages as the lurasidone component of NRX-101
Lurasidone Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions
Ketamine Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
|
Saline Followed by Lurasidone
n=1 participants at risk
Lurasidone will be administered in the same dosages as the lurasidone component of NRX-101
Lurasidone Oral Capsule: Prospective Randomized Factorial Design Study as per arm/group descriptions
Ketamine Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
Saline Solution Intravenous Infusion: Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
tinnitus
|
0.00%
0/12 • Study Duration (6 weeks)
|
0.00%
0/5 • Study Duration (6 weeks)
|
25.0%
1/4 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Eye disorders
Diplopia
|
8.3%
1/12 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/5 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Eye disorders
Vision blurred
|
8.3%
1/12 • Number of events 1 • Study Duration (6 weeks)
|
20.0%
1/5 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/12 • Study Duration (6 weeks)
|
20.0%
1/5 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/12 • Study Duration (6 weeks)
|
20.0%
1/5 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/12 • Study Duration (6 weeks)
|
0.00%
0/5 • Study Duration (6 weeks)
|
25.0%
1/4 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Gastrointestinal disorders
vomiting
|
8.3%
1/12 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/5 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Nervous system disorders
coordination abnormal
|
0.00%
0/12 • Study Duration (6 weeks)
|
20.0%
1/5 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • Study Duration (6 weeks)
|
40.0%
2/5 • Number of events 3 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Nervous system disorders
dysmetropsia
|
0.00%
0/12 • Study Duration (6 weeks)
|
20.0%
1/5 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Nervous system disorders
headache
|
8.3%
1/12 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/5 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Nervous system disorders
hypoasthesia
|
0.00%
0/12 • Study Duration (6 weeks)
|
40.0%
2/5 • Number of events 2 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Psychiatric disorders
Dissociation
|
16.7%
2/12 • Number of events 2 • Study Duration (6 weeks)
|
0.00%
0/5 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Psychiatric disorders
euphoric mood
|
16.7%
2/12 • Number of events 2 • Study Duration (6 weeks)
|
0.00%
0/5 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Psychiatric disorders
restlessness
|
16.7%
2/12 • Number of events 4 • Study Duration (6 weeks)
|
20.0%
1/5 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Skin and subcutaneous tissue disorders
dry skin
|
0.00%
0/12 • Study Duration (6 weeks)
|
20.0%
1/5 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Skin and subcutaneous tissue disorders
rash
|
8.3%
1/12 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/5 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Vascular disorders
hypertension
|
16.7%
2/12 • Number of events 2 • Study Duration (6 weeks)
|
20.0%
1/5 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Cardiac disorders
angina pectoris
|
0.00%
0/12 • Study Duration (6 weeks)
|
20.0%
1/5 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Cardiac disorders
palpitations
|
0.00%
0/12 • Study Duration (6 weeks)
|
0.00%
0/5 • Study Duration (6 weeks)
|
25.0%
1/4 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Eye disorders
vision blurred
|
16.7%
2/12 • Number of events 2 • Study Duration (6 weeks)
|
20.0%
1/5 • Number of events 1 • Study Duration (6 weeks)
|
25.0%
1/4 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Gastrointestinal disorders
abdominal distention
|
8.3%
1/12 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/5 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Gastrointestinal disorders
diarrhea
|
8.3%
1/12 • Number of events 1 • Study Duration (6 weeks)
|
20.0%
1/5 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Gastrointestinal disorders
dyspepsia
|
0.00%
0/12 • Study Duration (6 weeks)
|
0.00%
0/5 • Study Duration (6 weeks)
|
25.0%
1/4 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
0.00%
0/12 • Study Duration (6 weeks)
|
0.00%
0/5 • Study Duration (6 weeks)
|
25.0%
1/4 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
General disorders
fatigue
|
16.7%
2/12 • Number of events 3 • Study Duration (6 weeks)
|
0.00%
0/5 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Infections and infestations
vulvovaginal candidiasis
|
8.3%
1/12 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/5 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Injury, poisoning and procedural complications
thermal burn
|
8.3%
1/12 • Number of events 2 • Study Duration (6 weeks)
|
0.00%
0/5 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Injury, poisoning and procedural complications
wound
|
0.00%
0/12 • Study Duration (6 weeks)
|
0.00%
0/5 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
100.0%
1/1 • Number of events 1 • Study Duration (6 weeks)
|
|
Investigations
weight increased
|
8.3%
1/12 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/5 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
0.00%
0/12 • Study Duration (6 weeks)
|
0.00%
0/5 • Study Duration (6 weeks)
|
25.0%
1/4 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Nervous system disorders
akathisia
|
8.3%
1/12 • Number of events 3 • Study Duration (6 weeks)
|
0.00%
0/5 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Nervous system disorders
hypersomnia
|
8.3%
1/12 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/5 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Nervous system disorders
lethargy
|
8.3%
1/12 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/5 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Nervous system disorders
sedation
|
16.7%
2/12 • Number of events 2 • Study Duration (6 weeks)
|
20.0%
1/5 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Nervous system disorders
somnolence
|
8.3%
1/12 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/5 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Psychiatric disorders
anorgasmia
|
8.3%
1/12 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/5 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Psychiatric disorders
depressed mood
|
0.00%
0/12 • Study Duration (6 weeks)
|
0.00%
0/5 • Study Duration (6 weeks)
|
25.0%
1/4 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Psychiatric disorders
depression
|
0.00%
0/12 • Study Duration (6 weeks)
|
20.0%
1/5 • Number of events 1 • Study Duration (6 weeks)
|
25.0%
1/4 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Psychiatric disorders
suicidal ideation
|
0.00%
0/12 • Study Duration (6 weeks)
|
20.0%
1/5 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
100.0%
1/1 • Number of events 1 • Study Duration (6 weeks)
|
|
Renal and urinary disorders
acute kidney injury
|
0.00%
0/12 • Study Duration (6 weeks)
|
20.0%
1/5 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/4 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
|
Reproductive system and breast disorders
ejaculation delayed
|
0.00%
0/12 • Study Duration (6 weeks)
|
0.00%
0/5 • Study Duration (6 weeks)
|
25.0%
1/4 • Number of events 1 • Study Duration (6 weeks)
|
0.00%
0/1 • Study Duration (6 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place