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NCT05593029 · ClinicalTrials.gov registry record · Phase 2
A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults With Major Depressive Disorder
A Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 2
- Development phase
- 929
- Enrollment target
NCT05593029: Completed Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT05593029 is a Phase 2 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 929 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (598% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05593029, a Phase 2 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 929 participants
- Enrollment target
Study Summary
Demonstrate ability of SEP-363856 to be superior to placebo as an adjunctive therapy to ADT in change from baseline in depressive symptoms (MADRS \& CGI-S) in MDD patients who had an inadequate response to prior ADT therapy.
Primary Outcome
Change from the baseline to the Montgomery Åsberg Depression Rating Scale (MADRS) total score. The Montgomery Åsberg Depression Rating Scale consists of 10 items, each rated from 0 to 6 (for a total score of 0 to 60). A higher score represents a higher severity of the level of depression.
Interventions
- OTHER Placebo
- DRUG SEP-363856
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 929 participants |
| Start Date | 2022-11-09 |
| Est. Completion | 2025-11-13 |
| Phase | Phase 2 |
What the finished NCT05593029 record still lists
NCT05593029 is an interventional study that assigns participants to a tested intervention. The registered 929 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 (598% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05593029 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05593029 about?
NCT05593029 is a clinical study titled "A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults With Major Depressive Disorder". Demonstrate ability of SEP-363856 to be superior to placebo as an adjunctive therapy to ADT in change from baseline in depressive symptoms (MADRS \& CGI-S) in MDD patients who had an inadequate response to prior ADT therapy.
What is the current status of trial NCT05593029?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 929 participants. The study started on 2022-11-09. Estimated completion is 2025-11-13.
What interventions are being tested in trial NCT05593029?
The interventions under investigation include: Placebo (OTHER), SEP-363856 (DRUG).
Who is sponsoring clinical trial NCT05593029?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05593029's enrollment target sits among peer trials
929 29th of 2000 higher than 1,972 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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