Recruiting PHASE3 INTERVENTIONAL 2-arm NCT06372964

Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients

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

Sponsor: Intra-Cellular Therapies, Inc.

Conditions Bipolar Depression

Interventions Lumateperone Placebo

Updated 5 times since 2024 Last updated: Jul 3, 2025 Started: May 13, 2024 Primary completion: Apr 30, 2027 Completion: May 31, 2027

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Bipolar Depression, this trial is actively recruiting participants. The trial is conducted by Intra-Cellular Therapies, Inc. and has accumulated 5 data snapshots since 2024. Psychiatric clinical trials are essential for establishing evidence-based treatment standards.

Status Flow

Change History

5 versions recorded

Aug 2025 — Present [monthly]

Recruiting PHASE3
Sep 2024 — Aug 2025 [monthly]

Recruiting PHASE3
Aug 2024 — Sep 2024 [monthly]

Recruiting PHASE3
Jul 2024 — Aug 2024 [monthly]

Recruiting PHASE3
May 2024 — Jul 2024 [monthly]

Recruiting PHASE3

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Intra-Cellular Therapies, Inc.

Data source: Intra-Cellular Therapies, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Ahmedabad, India , Anaheim, United States , Atlanta, United States , Aurangabad, India , Austin, United States , Avon Lake, United States , Baltimore, United States , Belgrade, Serbia , Bellevue, United States , Bloomfield Hills, United States and 37 more locations