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NCT07549581 · ClinicalTrials.gov registry record · Phase 1
A Study of SEP-380135 in Adults With Schizophrenia or Major Depressive Episode
A Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT07549581: Completed Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT07549581 is a Phase 1 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07549581, a Phase 1 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple dose oral administration of SEP-380135 in participants with schizophrenia or with a major depressive episode associated with bipolar I or II disorder or major depressive disorder (MDD).
Interventions
- DRUG Placebo
- DRUG SEP-380135
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2024-11-07 |
| Est. Completion | 2025-09-12 |
| Phase | Phase 1 |
What the finished NCT07549581 record still lists
NCT07549581 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07549581 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07549581 about?
NCT07549581 is a clinical study titled "A Study of SEP-380135 in Adults With Schizophrenia or Major Depressive Episode". The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple dose oral administration of SEP-380135 in participants with schizophrenia or with a major depressive episode associated with bipolar I or II disorder or major depressive diso...
What is the current status of trial NCT07549581?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2024-11-07. Estimated completion is 2025-09-12.
What interventions are being tested in trial NCT07549581?
The interventions under investigation include: Placebo (DRUG), SEP-380135 (DRUG).
Who is sponsoring clinical trial NCT07549581?
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 NCT07549581's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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