Trials / Completed
CompletedNCT02600507
Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression
Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 Adjunctive to Lithium or Valproate in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 529 (actual)
- Sponsor
- Intra-Cellular Therapies, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lumateperone (ITI-007) | |
| DRUG | Placebo |
Timeline
- Start date
- 2016-03-07
- Primary completion
- 2020-07-02
- Completion
- 2020-07-02
- First posted
- 2015-11-09
- Last updated
- 2023-05-17
- Results posted
- 2023-05-17
Locations
71 sites across 5 countries: United States, Bulgaria, Russia, Serbia, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02600507. Inclusion in this directory is not an endorsement.