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Clinical trial

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess 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

NCT04285515 is registered in ClinicalTrials.gov with Intra-Cellular Therapies, Inc. as lead sponsor.

NCT NCT04285515
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess 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
Lead sponsor
Intra-Cellular Therapies, Inc.
Phase
Phase 3
Overall status
Completed
Start date
February 27, 2020
Completion date
November 30, 2022
Enrollment
488 (actual)
Sites
42

Conditions

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

bipolar depression, major depressive disorder