Phase 3
N=488
Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
Bipolar Depression · Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04285515 ↗Enrolled (actual)
488
Serious AEs
0.2%
Results posted
Mar 2025
Primary outcome: Primary: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score — -18.1; -12.4 score on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lumateperone (Drug); Placebos (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Intra-Cellular Therapies, Inc.
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score |
-17.7; -12.1 | <0.0001 sig |
| SECONDARY Clinical From Baseline in Clinical Global Impression Scale - Severity (CGI-S) |
-1.7; -1.1 | <0.0001 sig |
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 associated with Bipolar I or Bipolar II Disorder (Bipolar Depression) or major depressive disorder (MDD) who also meet the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5) criteria for mixed-features. The study consists of a Screening Period, a Double-blind Treatment Period, and a Safety Follow-up Period.
Eligibility Criteria
Major Inclusion Criteria:
- 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 Criteria:
- 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
Data sourced from ClinicalTrials.gov (NCT04285515). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.