Status:
COMPLETED
Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
Lead Sponsor:
Intra-Cellular Therapies, Inc.
Conditions:
Bipolar Depression
Major Depressive Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of lumateperone monotherapy in the treatment of patients with major depressive episodes as...
Eligibility Criteria
Inclusion
- Major
- Male or female subjects of any race, ages 18-75 inclusive
- Meets the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM 5) criteria for Bipolar I or Bipolar II Disorder or MDD
- The start of the current major depressive episode is at least 2 weeks but no more than 6 months prior to the Screening (Visit 1)
- Has at least moderate severity of illness, as measured by a rater-administered MADRS total score ≥ 24 and corresponding to a CGI S score of ≥ 4 at Screening (Visit 1) and Baseline (Visit 2)
- The patient meets the DSM-5 criteria for mixed-features specific to the Bipolar I or II diagnosis or MDD diagnosis
- Current major depressive episode is causing clinically significant distress or impairment in social, occupational, or other important areas of functioning
- 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
- The patient has a significant risk for suicidal behavior
- The patient presents with a lifetime history of epilepsy, seizure or convulsion, or electroencephalogram with clinically significant abnormalities, delirium, dementia, amnestic, or other cognitive disorder or significant brain trauma
Key Trial Info
Start Date :
February 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
488 Patients enrolled
Trial Details
Trial ID
NCT04285515
Start Date
February 27 2020
End Date
November 30 2022
Last Update
March 19 2025
Active Locations (42)
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1
Clinical Site
Garden Grove, California, United States, 92845
2
Clinical Site
Oceanside, California, United States, 92056
3
Clinical Site
Sherman Oaks, California, United States, 91403
4
Clinical Site
Lauderhill, Florida, United States, 33319