# An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

> **NCT05061719** · PHASE3 · COMPLETED · sponsor: **Intra-Cellular Therapies, Inc.** · enrollment: 812 (actual)

## Conditions studied

- Major Depressive Disorder

## Interventions

- **DRUG:** Lumateperone

## Key facts

- **NCT ID:** NCT05061719
- **Lead sponsor:** Intra-Cellular Therapies, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2021-10-08
- **Primary completion:** 2024-10-14
- **Final completion:** 2024-10-23
- **Target enrollment:** 812 (ACTUAL)
- **Last updated:** 2025-11-03


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05061719

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05061719, "An Open-label Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder". Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/clinical/NCT05061719. Licensed CC0.

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