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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 is a Phase 3 study that was terminated before completion, run by Sumitomo Pharma America. The registered enrollment target is 83 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05169710
The ClinicalTrials.gov registry entry for NCT05169710 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sumitomo Pharma America, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05169710 reports 0 study locations.
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.
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