Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
Completed · Phase 3 · Has a placebo group
Conditions studied: Bipolar Depression, Major Depressive Disorder
In brief
This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of lumateperone monotherapy in the treatment of patients with major depressive episodes associated with Bipolar I or Bipolar II Disorder (Bipolar Depression) or major depressive disorder (MDD) who also meet the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5) criteria for mixed-features. The study consists of a Screening Period, a Double-blind Treatment Period, and a Safety Follow-up Period.
Key facts
- Study ID
- NCT04285515
- Run by
- Intra-Cellular Therapies, Inc.
- People needed
- 488
- Starts
- 2020-02-27
- Expected to finish
- 2022-11-30
- Last updated by the study team
- 2025-03-19
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Clinical Site — Garden Grove, California, United States
- Clinical Site — Oceanside, California, United States
- Clinical Site — Sherman Oaks, California, United States
- Clinical Site — Lauderhill, Florida, United States
- Clinical Site — Miami, Florida, United States
- Clinical Site — Orange City, Florida, United States
- Clinical Site — Atlanta, Georgia, United States
- Clinical Site — Decatur, Georgia, United States
- Clinical Site — O'Fallon, Missouri, United States
- Clinical Site — Cedarhurst, New York, United States
- Clinical Site — New York, New York, United States
- Clinical Site — Charlotte, North Carolina, United States
- Clinical Site — Bellevue, Washington, United States
- Clinical Site — Burgas, Bulgaria
- Clinical Site — Kardzhali, Bulgaria
- Clinical Site — Plovdiv, Bulgaria
- Clinical Site — Rousse, Bulgaria
- Clinical Site — Sofia, Bulgaria
- Clinical Site — Sofia, Bulgaria
- Clinical Site — Sofia, Bulgaria
- Clinical Site — Sofia, Bulgaria
- Clinical Site — Varna, Bulgaria
- Clinical Site — Veliko Tarnovo, Bulgaria
- Clinical Site — Vratsa, Bulgaria
- Clinical Site — Moscow, Russia
Full record on ClinicalTrials.gov
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