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

Phase 3

Completed

• Conditions: Bipolar Depression; Major Depressive Disorder
• Interventions: Drug: Lumateperone; Drug: Placebos

• Registration Number: NCT04285515
• Lead Sponsor: Intra-Cellular Therapies, Inc.

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-02-24
• Study First Posted: 2020-02-26
• Study Start: 2020-02-27
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Status Verified: 2025-03
• Results First Submitted: 2025-03-04
• Results First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Results First Posted: 2025-03-19
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 488

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lumateperone 42mg	Lumateperone	Lumateperone 42mg administered once daily in the evening
Placebo	Placebos	Matching placebo administered once daily in the evening

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score	Day 43	The Montgomery-Åsberg Depression Rating Scale is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.

Secondary Outcome Measures

Name	Time	Method
Clinical From Baseline in Clinical Global Impression Scale - Severity (CGI-S)	Day 43	The Clinical Global Impression Scale-Severity is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

Trial Locations

Locations (2)

Clinical Site; 🇺🇦 Vinnytsia, Ukraine

Clinical site; 🇺🇦 Odesa, Ukraine