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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)
Conditions
Interventions
SEP-4199 CR
Locations
69
United States
University of Alabama at Birmingham Huntsville Regional Medical Campus
Huntsville, Alabama, United States
Advanced Research Center, Inc.
Anaheim, California, United States
Sun Valley Research Center
Imperial, California, United States
Clinical innovations, Inc.
Riverside, California, United States
Collaborative Neuroscience Research, LLC
Torrance, California, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Start Date
March 17, 2022
Primary Completion Date
November 17, 2023
Completion Date
November 17, 2023
Last Updated
February 21, 2025
Lead Sponsor
Sumitomo Pharma America, Inc.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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