Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
Completed · Phase 3 · Has a placebo group
Conditions studied: Bipolar Depression
In brief
The study will evaluate the efficacy and safety of ITI-007 in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.
Key facts
- Study ID
- NCT03249376
- Run by
- Intra-Cellular Therapies, Inc.
- People needed
- 381
- Starts
- 2017-11-27
- Expected to finish
- 2019-03-01
- Last updated by the study team
- 2022-06-03
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Clinical Site — Birmingham, Alabama, United States
- Clinical Site — Sherman Oaks, California, United States
- Clinical Site — Miami, Florida, United States
- Clinical Site — Orange City, Florida, United States
- Clinical Site — Atlanta, Georgia, United States
- Clinical Site — Decatur, Georgia, United States
- Clinical Site — Chicago, Illinois, United States
- Clinical Site — Joliet, Illinois, United States
- Clinical Site — Shreveport, Louisiana, United States
- Clinical Site — St Louis, Missouri, United States
- Clinical Site — Buffalo, New York, United States
- Clinical Site — Charlotte, North Carolina, United States
- Clinical Site — The Woodlands, Texas, United States
- Clinical Site — Bothell, Washington, United States
- Clinical Site — Burgas, Bulgaria
- Clinical Site — Kardzhali, Bulgaria
- Clinical Site — Lovech, Bulgaria
- Clinical Site — Plovdiv, Bulgaria
- Clinical Site — Rousse, Bulgaria
- Clinical Site — Sofia, Bulgaria
- Clinical Site — Targovishte, Bulgaria
- Clinical Site — Tsarev Brod, Bulgaria
- Clinical Site — Varna, Bulgaria
- Clinical Site — Veliko Tarnovo, Bulgaria
- Clinical Site — Barranquilla, Colombia
Full record on ClinicalTrials.gov
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