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Clinical trial

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lumateperone for the Treatment of Major Depressive Episodes (MDEs) Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) in Pediatric Patients Aged 10 to 17 Years

NCT06372964 is registered in ClinicalTrials.gov with Intra-Cellular Therapies, Inc. as lead sponsor.

NCT NCT06372964
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Registry record

As filed in ClinicalTrials.gov.

Title
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lumateperone for the Treatment of Major Depressive Episodes (MDEs) Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) in Pediatric Patients Aged 10 to 17 Years
Lead sponsor
Intra-Cellular Therapies, Inc.
Phase
Phase 3
Overall status
Recruiting
Start date
May 14, 2024
Completion date
October 31, 2031
Enrollment
384 (estimated)
Sites
68

Conditions

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

bipolar depression