# Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

> **NCT05850689** · PHASE3 · RECRUITING · sponsor: **Intra-Cellular Therapies, Inc.** · enrollment: 470 (estimated)

## Conditions studied

- Major Depressive Disorder

## Interventions

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

## Key facts

- **NCT ID:** NCT05850689
- **Lead sponsor:** Intra-Cellular Therapies, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2023-05-02
- **Primary completion:** 2026-09
- **Final completion:** 2026-10
- **Target enrollment:** 470 (ESTIMATED)
- **Last updated:** 2025-07-01


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05850689

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05850689, "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/NCT05850689. Licensed CC0.

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