Status:
COMPLETED
Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
Lead Sponsor:
Intra-Cellular Therapies, Inc.
Conditions:
Bipolar Depression
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 diso...
Eligibility Criteria
Inclusion
- Major
- 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
- able to provide written informed consent
- Major
Exclusion
- any female subject who is pregnant or breast-feeding
- any subject judged to be medically inappropriate for study participation
Key Trial Info
Start Date :
November 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
381 Patients enrolled
Trial Details
Trial ID
NCT03249376
Start Date
November 27 2017
End Date
March 1 2019
Last Update
June 3 2022
Active Locations (47)
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1
Clinical Site
Birmingham, Alabama, United States, 35294
2
Clinical Site
Sherman Oaks, California, United States, 91403
3
Clinical Site
Miami, Florida, United States, 33133
4
Clinical Site
Orange City, Florida, United States, 32763