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

> **NCT06372964** · PHASE3 · RECRUITING · sponsor: **Intra-Cellular Therapies, Inc.** · enrollment: 384 (estimated)

## Conditions studied

- Bipolar Depression

## Interventions

- **DRUG:** Lumateperone
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT06372964
- **Lead sponsor:** Intra-Cellular Therapies, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2024-05-13
- **Primary completion:** 2027-04
- **Final completion:** 2027-05
- **Target enrollment:** 384 (ESTIMATED)
- **Last updated:** 2025-07-08


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06372964

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06372964, "Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients". Retrieved via AI Analytics 2026-06-03 from https://api.ai-analytics.org/clinical/NCT06372964. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*