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Clinical trial

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Fixed Doses of Lumateperone Administered as Monotherapy in Participants With Major Depressive Disorder and an Open-label Long-term Extension Treatment With Lumateperone

NCT07747389 is registered in ClinicalTrials.gov with Intra-Cellular Therapies, Inc. as lead sponsor.

NCT NCT07747389
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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 Fixed Doses of Lumateperone Administered as Monotherapy in Participants With Major Depressive Disorder and an Open-label Long-term Extension Treatment With Lumateperone
Lead sponsor
Intra-Cellular Therapies, Inc.
Phase
Phase 3
Overall status
Not yet recruiting
Start date
October 20, 2026
Completion date
September 20, 2029
Enrollment
585 (estimated)
Sites
Not reported

Conditions

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

depressive disorder, major