Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess 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

Conditions
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Bipolar Depression, Major Depressive Disorder

Intervention / Treatment
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* Drug: Lumateperone
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumateperone 42mg<br>Lumateperone 42mg administered once daily in the evening | Drug: Lumateperone<br>* Lumateperone 42mg oral capsule<br>|
| Placebo Comparator: Placebo<br>Matching placebo administered once daily in the evening | Drug: Placebos<br>* Placebo oral capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Åsberg Depression Rating Scale |  | Day 43 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression Scale - Severity |  | Day 43 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mixed Features