# Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally

> **NCT03249376** · PHASE3 · COMPLETED · sponsor: **Intra-Cellular Therapies, Inc.** · enrollment: 381 (actual)

## Conditions studied

- Bipolar Depression

## Interventions

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

## Key facts

- **NCT ID:** NCT03249376
- **Lead sponsor:** Intra-Cellular Therapies, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2017-11-27
- **Primary completion:** 2019-03-01
- **Final completion:** 2019-03-01
- **Target enrollment:** 381 (ACTUAL)
- **Last updated:** 2022-06-03


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03249376

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03249376, "Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT03249376. Licensed CC0.

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