# Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression

> **NCT02600494** · PHASE3 · COMPLETED · sponsor: **Intra-Cellular Therapies, Inc.** · enrollment: 554 (actual)

## Conditions studied

- Bipolar Depression

## Interventions

- **DRUG:** ITI-007 (Lumateperone)
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT02600494
- **Lead sponsor:** Intra-Cellular Therapies, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2015-12-15
- **Primary completion:** 2019-01-28
- **Final completion:** 2019-07-24
- **Target enrollment:** 554 (ACTUAL)
- **Last updated:** 2025-11-03


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02600494

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02600494, "Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression". Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/clinical/NCT02600494. Licensed CC0.

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