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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 is a Phase 3 study that was terminated before completion, run by Sumitomo Pharma America. The registered enrollment target is 64 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05227209
The ClinicalTrials.gov registry entry for NCT05227209 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 64 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 1 intervention - of which SEP-4199 CR is the first listed.
NCT05227209 reports 0 study locations.
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.
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