At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 344 enrolled
Drug / intervention
SEP-4199 200 mg +2 moredrug
Likely dose
SEP-4199 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of SEP-4199 for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression)
In Brief
A Phase 2 clinical trial evaluating SEP-4199 200 mg, SEP-4199 400 mg, and 1 other intervention for Depressive Episode and Bipolar 1 Depression. Completed, enrolled 344 participants across 87 sites in 8 countries.
Detailed Summary
A clinical study to test the effectiveness of an investigational drug to treat people that have major depressive episodes when they have Bipolar 1 Depression
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepressive Episode, Bipolar 1 Depression
CountriesBulgaria, Japan, Poland, Russia, Serbia, Slovakia, Ukraine, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJun 2018
Enrollment StartJun 2018
Primary CompletionApr 2020
TodayJul 2026
First PostedJun 1, 2018
Enrollment StartJun 26, 2018
Primary CompletionApr 23, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.1 years ago
Interventions
SEP-4199 200 mgdrug
SEP-4199 200 mg/day (supplied in two 100mg tablets)
SEP-4199 400 mgdrug
SEP-4199 400 mg/day (supplied in two 200mg tablets
Placebodrug
Placebo (supplied in two tablets/day)