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NCT05169710 · ClinicalTrials.gov registry record · Phase 3
A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder.
A Phase 3 study, sponsored by Sumitomo Pharma America.
- Terminated
- Registry status
- Phase 3
- Development phase
- 83
- Enrollment target
NCT05169710: Clinical Trial Phase 3 study, sponsored by Sumitomo Pharma America.
NCT05169710 is a Phase 3 study that was terminated before completion, run by Sumitomo Pharma America. The registered enrollment target is 83 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05169710, a Phase 3 study, was terminated before completion, sponsored by Sumitomo Pharma America.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 83 participants
- Enrollment target
Study Summary
A clinical trial to study the efficacy and safety of an investigational drug in people with major depressive episodes associated with with Bipolar I disorder (bipolar I depression) Participants in the study will either receive the drug being studied or a placebo. The study will be conducted in approximately 90 sites in North America, Europe, Latin America and Japan. It will be have both male and female participants ages 18-65. Participation in the study will be approximately 10 weeks.
Primary Outcome
Montgomery-Asberg Depression Rating Scale (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 CR 200 mg
- DRUG SEP-4199 CR 400 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2021-12-21 |
| Est. Completion | 2023-10-18 |
| Phase | Phase 3 |
Why NCT05169710 stopped before completion
NCT05169710 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05169710 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05169710 about?
NCT05169710 is a clinical study titled "A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder.". A clinical trial to study the efficacy and safety of an investigational drug in people with major depressive episodes associated with with Bipolar I disorder (bipolar I depression) Participants in the study will either receive the drug being studied or a placebo. The study will be conducted in appro...
What is the current status of trial NCT05169710?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 83 participants. The study started on 2021-12-21. Estimated completion is 2023-10-18.
What interventions are being tested in trial NCT05169710?
The interventions under investigation include: Placebo (DRUG), SEP-4199 CR 200 mg (DRUG), SEP-4199 CR 400 mg (DRUG).
Who is sponsoring clinical trial NCT05169710?
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 NCT05169710's enrollment target sits among peer trials
83 1751st of 2000 higher than 249 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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