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Clinical trial

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients With Manic Episodes or Manic Episodes With Mixed Features Associated With Bipolar I Disorder (Bipolar Mania)

NCT06462612 is registered in ClinicalTrials.gov with Intra-Cellular Therapies, Inc. as lead sponsor.

NCT NCT06462612
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Registry record

As filed in ClinicalTrials.gov.

Title
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients With Manic Episodes or Manic Episodes With Mixed Features Associated With Bipolar I Disorder (Bipolar Mania)
Lead sponsor
Intra-Cellular Therapies, Inc.
Phase
Phase 3
Overall status
Completed
Start date
July 17, 2024
Completion date
May 20, 2026
Enrollment
351 (actual)
Sites
35

Conditions

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

bipolar disorder, manic