Trial Outcomes & Findings for A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder. (NCT NCT05169710)
NCT ID: NCT05169710
Last Updated: 2024-10-03
Results Overview
Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician-rated assessment of the subject's level of depression. The measure contains 10 items that measure apparent and reported sadness, inner tension, reduced sleep and appetite, difficulty concentrating, lassitude, inability to feel, and pessimistic and suicidal thoughts, each ranging from 0 to 6. The MADRS total score ranges from 0 to 60, with higher scores indicating increased depressive symptoms
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
83 participants
Primary outcome timeframe
6 Weeks
Results posted on
2024-10-03
Participant Flow
All participants had to go through at least 3 days or 5 half-lives antipsychotic medication washout.In total 83 Participants are Randomized in the trial, however one of the participant is randomized in error and was discontinued from study before taking any IP, So this subject is not considered in analysis population. Hence we have difference of 1 subject in Enrollment Number.
Participant milestones
| Measure |
Placebo
Placebo: Placebo tablet (supplied in two tablets)
|
SEP-4199 CR 200 mg
SEP-4199 CR 200 mg: SEP-4199 CR 200 mg Tablet (supplied in one 200mg tablet and one placebo tablet)
|
SEP-4199 CR 400 mg
SEP-4199 CR 400 mg: SEP-4199 CR 400 mg tablet (supplied in two 200mg tablets)
|
|---|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
28
|
|
Overall Study
COMPLETED
|
24
|
22
|
25
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: Placebo tablet (supplied in two tablets)
|
SEP-4199 CR 200 mg
SEP-4199 CR 200 mg: SEP-4199 CR 200 mg Tablet (supplied in one 200mg tablet and one placebo tablet)
|
SEP-4199 CR 400 mg
SEP-4199 CR 400 mg: SEP-4199 CR 400 mg tablet (supplied in two 200mg tablets)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
|
Overall Study
Other Study Discontinuation Reason
|
0
|
2
|
0
|
Baseline Characteristics
A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder.
Baseline characteristics by cohort
| Measure |
Placebo
n=27 Participants
Placebo: Placebo tablet (supplied in two tablets)
|
SEP-4199 CR 200 mg
n=27 Participants
SEP-4199 CR 200 mg: SEP-4199 CR 200 mg Tablet (supplied in one 200mg tablet and one placebo tablet)
|
SEP-4199 CR 400 mg
n=28 Participants
SEP-4199 CR 400 mg: SEP-4199 CR 400 mg tablet (supplied in two 200mg tablets)
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.9 Years
STANDARD_DEVIATION 11.34 • n=5 Participants
|
46.7 Years
STANDARD_DEVIATION 11.67 • n=7 Participants
|
42.8 Years
STANDARD_DEVIATION 12.53 • n=5 Participants
|
44.5 Years
STANDARD_DEVIATION 11.83 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
30 Participants
n=4 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
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
29 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
50 Participants
n=4 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
|
|
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
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Region of Enrollment
Bulgaria
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Region of Enrollment
Romania
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Baseline Montgomery-Asberg Depression Rating Scale( MADRS )Total Score
|
36.6 units on a scale
STANDARD_DEVIATION 5.64 • n=5 Participants
|
37.5 units on a scale
STANDARD_DEVIATION 6.22 • n=7 Participants
|
37.6 units on a scale
STANDARD_DEVIATION 4.92 • n=5 Participants
|
37.2 units on a scale
STANDARD_DEVIATION 5.55 • n=4 Participants
|
|
Baseline Clinical Global Impressions - Severity: Bipolar Version (CGI-BP-S) score (depression)
|
5 units on a scale
STANDARD_DEVIATION 0.65 • n=5 Participants
|
5 units on a scale
STANDARD_DEVIATION 0.68 • n=7 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 0.69 • n=5 Participants
|
5 units on a scale
STANDARD_DEVIATION 0.66 • n=4 Participants
|
PRIMARY outcome
Timeframe: 6 WeeksPopulation: ITT population
Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician-rated assessment of the subject's level of depression. The measure contains 10 items that measure apparent and reported sadness, inner tension, reduced sleep and appetite, difficulty concentrating, lassitude, inability to feel, and pessimistic and suicidal thoughts, each ranging from 0 to 6. The MADRS total score ranges from 0 to 60, with higher scores indicating increased depressive symptoms
Outcome measures
| Measure |
Placebo
n=27 Participants
Placebo: Placebo tablet (supplied in two tablets)
|
SEP-4199 CR 200 mg
n=27 Participants
SEP-4199 CR 200 mg: SEP-4199 CR 200 mg Tablet (supplied in one 200mg tablet and one placebo tablet)
|
SEP-4199 CR 400 mg
n=28 Participants
SEP-4199 CR 400 mg: SEP-4199 CR 400 mg tablet (supplied in two 200mg tablets)
|
|---|---|---|---|
|
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 6
|
-10.33 units on a scale
Standard Error 2.004
|
-14.27 units on a scale
Standard Error 2.055
|
-16.67 units on a scale
Standard Error 2.014
|
SECONDARY outcome
Timeframe: 6 WeeksPopulation: ITT population
Clinical Global Impressions Severity: Bipolar Version (CGI-BP-S) score (depression) is a single value, clinician-rated assessment of illness severity, and 7-point scale with range from 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill subjects. A higher score is associated with greater illness severity.
Outcome measures
| Measure |
Placebo
n=27 Participants
Placebo: Placebo tablet (supplied in two tablets)
|
SEP-4199 CR 200 mg
n=27 Participants
SEP-4199 CR 200 mg: SEP-4199 CR 200 mg Tablet (supplied in one 200mg tablet and one placebo tablet)
|
SEP-4199 CR 400 mg
n=28 Participants
SEP-4199 CR 400 mg: SEP-4199 CR 400 mg tablet (supplied in two 200mg tablets)
|
|---|---|---|---|
|
Change From Baseline in Global Severity Assessed by the Clinical Global Impressions Severity: Bipolar Version (CGI-BP-S) Score (Depression) at Week 6
|
-1.16 units on a scale
Standard Error 0.214
|
-1.26 units on a scale
Standard Error 0.222
|
-1.46 units on a scale
Standard Error 0.217
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
SEP-4199 CR 200 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SEP-4199 CR 400 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=27 participants at risk
Placebo: Placebo tablet (supplied in two tablets)
|
SEP-4199 CR 200 mg
n=27 participants at risk
SEP-4199 CR 200 mg: SEP-4199 CR 200 mg Tablet (supplied in one 200mg tablet and one placebo tablet)
|
SEP-4199 CR 400 mg
n=28 participants at risk
SEP-4199 CR 400 mg: SEP-4199 CR 400 mg tablet (supplied in two 200mg tablets)
|
|---|---|---|---|
|
Nervous system disorders
Somnolence
|
7.4%
2/27 • Number of events 2 • Up to 7 weeks
Adverse events were untoward medical occurrences that occurred on or after the first dose of study medication.
|
0.00%
0/27 • Up to 7 weeks
Adverse events were untoward medical occurrences that occurred on or after the first dose of study medication.
|
7.1%
2/28 • Number of events 3 • Up to 7 weeks
Adverse events were untoward medical occurrences that occurred on or after the first dose of study medication.
|
|
Nervous system disorders
Headache
|
11.1%
3/27 • Number of events 4 • Up to 7 weeks
Adverse events were untoward medical occurrences that occurred on or after the first dose of study medication.
|
0.00%
0/27 • Up to 7 weeks
Adverse events were untoward medical occurrences that occurred on or after the first dose of study medication.
|
0.00%
0/28 • Up to 7 weeks
Adverse events were untoward medical occurrences that occurred on or after the first dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
7.4%
2/27 • Number of events 2 • Up to 7 weeks
Adverse events were untoward medical occurrences that occurred on or after the first dose of study medication.
|
0.00%
0/27 • Up to 7 weeks
Adverse events were untoward medical occurrences that occurred on or after the first dose of study medication.
|
7.1%
2/28 • Number of events 2 • Up to 7 weeks
Adverse events were untoward medical occurrences that occurred on or after the first dose of study medication.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/27 • Up to 7 weeks
Adverse events were untoward medical occurrences that occurred on or after the first dose of study medication.
|
3.7%
1/27 • Number of events 1 • Up to 7 weeks
Adverse events were untoward medical occurrences that occurred on or after the first dose of study medication.
|
7.1%
2/28 • Number of events 2 • Up to 7 weeks
Adverse events were untoward medical occurrences that occurred on or after the first dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER