Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
Completed · Phase 3 · Has a placebo group
Conditions studied: Bipolar Depression
In brief
The study will evaluate the efficacy and safety of ITI-007 (Lumateperone) in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode. The study will be conducted in two parts, Part A and Part B. Part A is a randomized, double-blind, placebo-controlled study. In Part B, patients who safely complete participation in part A may be enrolled in an open-label extension.
Key facts
- Study ID
- NCT02600494
- Run by
- Intra-Cellular Therapies, Inc.
- People needed
- 554
- Starts
- 2015-12-15
- Expected to finish
- 2019-07-24
- Last updated by the study team
- 2025-11-03
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Clinical Site — Rogers, Arkansas, United States
- Clinical Site — Cerritos, California, United States
- Clinical Site — Culver City, California, United States
- Clinical Site — Garden Grove, California, United States
- Clinical Site — Lemon Grove, California, United States
- Clinical Site — National City, California, United States
- Clinical Site — Oakland, California, United States
- Clinical Site — Oceanside, California, United States
- Clinical Site — Orange, California, United States
- Clinical Site — Pico Rivera, California, United States
- Clinical Site — Riverside, California, United States
- Clinical Site — San Diego, California, United States
- Clinical Site — San Marcos, California, United States
- Clinical Site — Santa Rosa, California, United States
- Clinical Site — Colorado Springs, Colorado, United States
- Clinical Site — Bradenton, Florida, United States
- Clinical Site — Fort Myers, Florida, United States
- Clinical Site — Jacksonville, Florida, United States
- Clinical Site — Lauderhill, Florida, United States
- Clinical Site — Miami, Florida, United States
- Clinical Site — North Miami, Florida, United States
- Clinical Site — Orlando, Florida, United States
- Clinical Site — Atlanta, Georgia, United States
- Clinical Site — Chicago, Illinois, United States
- Clinical Site — Little Rock, Arkansas, United States
Full record on ClinicalTrials.gov
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