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NCT03543410 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 2
- Development phase
- 344
- Enrollment target
NCT03543410: Completed Phase 2 study, sponsored by Sumitomo Pharma America.
NCT03543410 is a Phase 2 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 344 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (159% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03543410, a Phase 2 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 344 participants
- Enrollment target
Study 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
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG SEP-4199 200 mg
- DRUG SEP-4199 400 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 344 participants |
| Start Date | 2018-06-26 |
| Est. Completion | 2020-04-23 |
| Phase | Phase 2 |
What the finished NCT03543410 record still lists
NCT03543410 is an interventional study that assigns participants to a tested intervention. The registered 344 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (159% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03543410 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03543410 about?
NCT03543410 is a clinical study titled "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". 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
What is the current status of trial NCT03543410?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 344 participants. The study started on 2018-06-26. Estimated completion is 2020-04-23.
What interventions are being tested in trial NCT03543410?
The interventions under investigation include: Placebo (DRUG), SEP-4199 200 mg (DRUG), SEP-4199 400 mg (DRUG).
Who is sponsoring clinical trial NCT03543410?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03543410's enrollment target sits among peer trials
344 136th of 2000 higher than 1,865 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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