# Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder

> **NCT04285515** · PHASE3 · COMPLETED · sponsor: **Intra-Cellular Therapies, Inc.** · enrollment: 488 (actual)

## Conditions studied

- Bipolar Depression
- Major Depressive Disorder

## Interventions

- **DRUG:** Lumateperone
- **DRUG:** Placebos

## Key facts

- **NCT ID:** NCT04285515
- **Lead sponsor:** Intra-Cellular Therapies, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2020-02-27
- **Primary completion:** 2022-11-30
- **Final completion:** 2022-11-30
- **Target enrollment:** 488 (ACTUAL)
- **Last updated:** 2025-03-19


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04285515

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04285515, "Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder". Retrieved via AI Analytics 2026-07-09 from https://api.ai-analytics.org/clinical/NCT04285515. Licensed CC0.

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