Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
Phase 3
Completed
- Conditions
- Bipolar Depression
- Interventions
- Drug: PlaceboDrug: ITI-007 (Lumateperone)
- Registration Number
- NCT02600494
- Lead Sponsor
- Intra-Cellular Therapies, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 554
Inclusion Criteria
- male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis of Bipolar I or Bipolar II disorder
- experiencing a current major depressive episode
Major
Exclusion Criteria
- any subject unable to provide informed consent
- any female subject who is pregnant or breast-feeding
- any subject judged to be medically inappropriate for study participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo administered orally as visually-matched capsules once daily for 6 weeks 40 mg ITI-007 (Lumateperone) ITI-007 (Lumateperone) 40 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks 60 mg ITI-007 (Lumateperone) ITI-007 (Lumateperone) 60 mg ITI-007 (Lumateperone) administered orally as capsules once daily for 6 weeks
- Primary Outcome Measures
Name Time Method Montgomery-Åsberg Depression Rating Scale (MADRS) 6 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Site
🇺🇸Everett, Washington, United States