A Clinical Study to Test the Effectiveness of an Investigational Drug to Treat People That Have Major Depressive Episodes When They Have Bipolar 1 Depression

Phase 2 Completed 344 enrolled Sumitomo Pharma America, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A clinical study to test the effectiveness of an investigational drug to treat people that have major depressive episodes when they have Bipolar 1 Depression

Timeline

Start: 2018-06-26
Primary completion: 2020-04-23
Completion: 2020-04-23

Outcome

Met primary endpoint

registry analysis (superiority test); SEP-4199 200 mg vs Placebo; p = 0.044; Mean Difference (Final Values) -3.290 (95% CI -6.489 to -0.090); Mixed Models Analysis; note: nominal p-value NCT03543410 ↗

Publications

Hopkins SC, Tomioka S, Szabo ST, Koblan KS. A clinical trial inclusion criteria to enrich for patients presenting with canonical symptom structure in bipolar depression. Contemp Clin Trials. 2024 Oct;145:107644. doi: 10.1016/j.cct.2024.107644. Epub 2024 Aug 3.
Hopkins SC, Wilkinson S, Corriveau TJ, Nishikawa H, Nakamichi K, Loebel A, Koblan KS. Discovery of Nonracemic Amisulpride to Maximize Benefit/Risk of 5-HT7 and D2 Receptor Antagonism for the Treatment of Mood Disorders. Clin Pharmacol Ther. 2021 Sep;110(3):808-815. doi: 10.1002/cpt.2282. Epub 2021 Jun 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SEP-4199	Unknown	200 mg	—
Subject	SEP-4199	Unknown	400 mg	—