Phase 3
Completed N=488
Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
Source: ClinicalTrials.gov NCT04285515 ↗Enrolled (actual)
488
Serious AEs
0.2%
Results posted
Mar 2025
Primary outcomePrimary: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score — -18.1; -12.4 score on a scale — p=<0.0001
◆ Published Evidence
Emerging
15citations · ~15 / year
Lumateperone for the Treatment of Major Depressive Disorder With Mixed Features or Bipolar Depression With Mixed Features: A Randomized Placebo-Controlled Trial.
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.
Linked Publications
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Lumateperone for the Treatment of Major Depressive Disorder With Mixed Features or Bipolar Depression With Mixed Features: A Randomized Placebo-Controlled Trial.
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 |
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) and the linked publication. 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. Informational only — not medical advice.