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Clinical trial

A 12-Month Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Effectiveness of SEP-4199 Controlled Release (CR) for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression)

NCT05227209 is registered in ClinicalTrials.gov with Sumitomo Pharma America, Inc. as lead sponsor.

NCT NCT05227209
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Registry record

As filed in ClinicalTrials.gov.

Title
A 12-Month Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Effectiveness of SEP-4199 Controlled Release (CR) for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression)
Lead sponsor
Sumitomo Pharma America, Inc.
Phase
Phase 3
Overall status
Terminated
Start date
March 17, 2022
Completion date
November 17, 2023
Enrollment
64 (actual)
Sites
69

Conditions

As the registry lists them; a condition with its own page is linked.

depressive episodes, bipolar i depression