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

March 4, 2025 updated by: Intra-Cellular Therapies, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

488

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Burgas, Bulgaria, 8000
        • Clinical Site
      • Kardzhali, Bulgaria, 6600
        • Clinical Site
      • Plovdiv, Bulgaria, 4004
        • Clinical Site
      • Ruse, Bulgaria, 7003
        • Clinical Site
      • Sofia, Bulgaria, 1431
        • Clinical Site
      • Sofia, Bulgaria, 1113
        • Clinical Site
      • Sofia, Bulgaria, 1408
        • Clinical Site
      • Sofia, Bulgaria, 1680
        • Clinical Site
      • Varna, Bulgaria, 9020
        • Clinical Site
      • Veliko Tarnovo, Bulgaria, 5000
        • Clinical Site
      • Vratsa, Bulgaria, 3000
        • Clinical Site
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620030
        • Clinical Site
      • Moscow, Russian Federation, 105082
        • Clinical Site
      • Saint Petersburg, Russian Federation, 190121
        • Clinical Site
      • Saint Petersburg, Russian Federation, 192019
        • Clinical Site
      • Saint Petersburg, Russian Federation, 195160
        • Clinical Site
      • Saint Petersburg, Russian Federation, 197341
        • Clinical Site
      • Saint Petersburg, Russian Federation, 199106
        • Clinical Site
      • Tomsk, Russian Federation, 634009
        • Clinical Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Site
      • Kovin, Serbia, 26220
        • Clinical Site
      • Kragujevac, Serbia, 34000
        • Clinical Site
  • Ukraine
      • Kyiv, Ukraine, 1133
        • Clinical Site
      • Lviv, Ukraine, 79021
        • Clinical Site
      • Odesa, Ukraine, 65006
        • Clinical Site
      • Odesa, Ukraine, 67513
        • Clinical Site
      • Poltava, Ukraine, 36013
        • Clinical Site
      • Smila, Ukraine, 20708
        • Clinical Site
      • Vinnytsia, Ukraine, 21005
        • Clinical Site
  • United States
    • California
      • Garden Grove, California, United States, 92845
        • Clinical Site
      • Oceanside, California, United States, 92056
        • Clinical Site
      • Sherman Oaks, California, United States, 91403
        • Clinical Site
    • Florida
      • Lauderhill, Florida, United States, 33319
        • Clinical Site
      • Miami, Florida, United States, 33122
        • Clinical Site
      • Orange City, Florida, United States, 32763
        • Clinical Site
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Clinical Site
      • Decatur, Georgia, United States, 30030
        • Clinical Site
    • Missouri
      • O'Fallon, Missouri, United States, 63368
        • Clinical Site
    • New York
      • Cedarhurst, New York, United States, 11694
        • Clinical Site
      • New York, New York, United States, 10128
        • Clinical Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Clinical Site
    • Washington
      • Bellevue, Washington, United States, 98007
        • Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Time Frame: 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.
Day 43

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical From Baseline in Clinical Global Impression Scale - Severity (CGI-S)
Time Frame: 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).
Day 43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intra-Cellular Therapies, Inc.

Investigators

  • Study Director: Susan Kozauer, MD, Intra-Cellular Therapies, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2020

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

February 24, 2020

First Submitted That Met QC Criteria

February 24, 2020

First Posted (Actual)

February 26, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITI-007-403

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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