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Clinical trial

A Multi-region, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating SEP-4199 Controlled Release (CR) for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression)

NCT05169710 is registered in ClinicalTrials.gov with Sumitomo Pharma America, Inc. as lead sponsor.

NCT NCT05169710
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Registry record

As filed in ClinicalTrials.gov.

Title
A Multi-region, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating 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
December 21, 2021
Completion date
October 18, 2023
Enrollment
83 (actual)
Sites
89

Conditions

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

depressive episodes, bipolar i depression