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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 is a Phase 2 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 929 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05593029
The ClinicalTrials.gov registry entry for NCT05593029 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 929 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05593029 reports 0 study locations.
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.
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