# Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression

> **NCT02600507** · PHASE3 · COMPLETED · sponsor: **Intra-Cellular Therapies, Inc.** · enrollment: 529 (actual)

## Conditions studied

- Bipolar Depression

## Interventions

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

## Key facts

- **NCT ID:** NCT02600507
- **Lead sponsor:** Intra-Cellular Therapies, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2016-03-07
- **Primary completion:** 2020-07-02
- **Final completion:** 2020-07-02
- **Target enrollment:** 529 (ACTUAL)
- **Last updated:** 2023-05-17


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02600507

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02600507, "Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression". Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/clinical/NCT02600507. Licensed CC0.

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