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NCT05227209 · ClinicalTrials.gov registry record · Phase 3
A Clinical Trial to Determine the Long-term Safety and Tolerability of an Investigational Drug in People With Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression).
A Phase 3 study, sponsored by Sumitomo Pharma America.
- Terminated
- Registry status
- Phase 3
- Development phase
- 64
- Enrollment target
NCT05227209: Clinical Trial Phase 3 study, sponsored by Sumitomo Pharma America.
NCT05227209 is a Phase 3 study that was terminated before completion, run by Sumitomo Pharma America. The registered enrollment target is 64 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05227209, a Phase 3 study, was terminated before completion, sponsored by Sumitomo Pharma America.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 64 participants
- Enrollment target
Study Summary
This is a clinical trial to determine the long-term safety and tolerability of an investigational drug in people with Major Depressive Episode Associated with Bipolar I Disorder (Bipolar I Depression). Participants in the study will receive the drug being studied. This study is accepting male and female participants between 18 and 65 years old who have completed Study SEP380-301. This study will be conducted in approximately 90 study centers worldwide. The treatment duration for this study is one (1) year.
Primary Outcome
Incidence of adverse events
Interventions
- DRUG SEP-4199 CR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2022-03-17 |
| Est. Completion | 2023-11-17 |
| Phase | Phase 3 |
Why NCT05227209 stopped before completion
NCT05227209 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which SEP-4199 CR is the first listed.
NCT05227209 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05227209 about?
NCT05227209 is a clinical study titled "A Clinical Trial to Determine the Long-term Safety and Tolerability of an Investigational Drug in People With Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression).". This is a clinical trial to determine the long-term safety and tolerability of an investigational drug in people with Major Depressive Episode Associated with Bipolar I Disorder (Bipolar I Depression). Participants in the study will receive the drug being studied. This study is accepting male and fe...
What is the current status of trial NCT05227209?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 64 participants. The study started on 2022-03-17. Estimated completion is 2023-11-17.
What interventions are being tested in trial NCT05227209?
The interventions under investigation include: SEP-4199 CR (DRUG).
Who is sponsoring clinical trial NCT05227209?
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 NCT05227209's enrollment target sits among peer trials
64 1799th of 2000 higher than 201 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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