Study of Lumateperone in the Treatment of Patients With Bipolar Mania

June 27, 2025 updated by: Intra-Cellular Therapies, Inc.

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients With Manic Episodes or Manic Episodes With Mixed Features Associated With Bipolar I Disorder (Bipolar Mania)

This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with or without psychotic symptoms, according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted in 3 phases:

  • Screening Period (up to 1 week) during which patient eligibility will be assessed.
  • Double-blind Treatment Period (3 weeks) during which all eligible patients will be randomized to receive lumateperone 42 mg or placebo in 1:1 ratio.
  • Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up visit

Study Type

Interventional

Enrollment (Estimated)

350

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 Contact

Study Locations

  • Bulgaria
      • Burgas, Bulgaria, 8000
        • Recruiting
        • Clinical Site
      • Kazanlak, Bulgaria, 6100
        • Recruiting
        • Clinical Site
      • Plovdiv, Bulgaria, 4002
        • Recruiting
        • Clinical Site
      • Sliven, Bulgaria, 8800
        • Recruiting
        • Clinical Site
      • Sofia, Bulgaria, 1431
        • Recruiting
        • Clinical Site
  • Romania
      • Braşov, Romania, 507190
        • Recruiting
        • Clinical Site
      • Bucuresti, Romania, 06022
        • Recruiting
        • Clinical Site
      • Iaşi, Romania, 700282
        • Recruiting
        • Clinical Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Clinical Site
      • Kovin, Serbia, 26220
        • Recruiting
        • Clinical Site
      • Kragujevac, Serbia, 34000
        • Recruiting
        • Clinical Site
      • Niš, Serbia
        • Recruiting
        • Clinical Site
      • Novi Kneževac, Serbia
        • Recruiting
        • Clinical Site
  • United States
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Recruiting
        • Clinical Site
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Clinical Site
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Clinical Site
      • Cerritos, California, United States, 90703
        • Recruiting
        • Clinical Site
      • Orange, California, United States, 92868
        • Recruiting
        • Clinical Site
      • Torrance, California, United States, 90504
        • Recruiting
        • Clinical Site
    • Florida
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33122
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33135
        • Recruiting
        • Clinical Site
      • Miami, Florida, United States, 33145
        • Recruiting
        • Clinical Site
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Clinical Site
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • Clinical Site
      • Tampa, Florida, United States, 33629
        • Recruiting
        • Clinical Site
      • West Palm Beach, Florida, United States, 33407
        • Recruiting
        • Clinical Site
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Recruiting
        • Clinical Site
      • Stockbridge, Georgia, United States, 30281
        • Recruiting
        • Clinical Site
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Recruiting
        • Clinical Site
      • Chicago, Illinois, United States, 60641
        • Recruiting
        • Clinical Site
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • Recruiting
        • Clinical Site
    • New York
      • Glen Oaks, New York, United States, 11004
        • Not yet recruiting
        • Clinical Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Not yet recruiting
        • Clinical Site
    • Texas
      • Richardson, Texas, United States, 75080
        • Recruiting
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Able to provide written informed consent before the initiation of any study specific procedures;
  2. Male or female inpatient, between the ages of 18 and 75 years, inclusive;
  3. Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) criteria for bipolar I disorder with a current episode of mania or mania with mixed features with or without psychotic symptoms, as confirmed by a trained and Sponsor-approved rater using the modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT);
  4. YMRS total score ≥ 20 and a score of at least 4 on two of the following YMRS items: irritability, speech, content, and disruptive/aggressive behavior at Screening and Baseline;
  5. Hospitalized voluntarily before Screening or admitted to inpatient unit at Visit 1 with a primary diagnosis of mania but not > 14 days before Screening. Hospital admission must be a result of the current manic episode.

Exclusion Criteria:

  1. Has a current primary DSM 5 psychiatric diagnosis other than bipolar disorder. These include:

    1. Schizophrenia, schizoaffective disorder, or other psychotic disorders;
    2. Dementia or other cognitive disorders;
    3. Intellectual disability;
    4. Moderate or severe substance use disorder (excluding for nicotine);
  2. Experiencing first manic episode;

  3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of his/her participation in the study or

    1. At Screening, the patient scores "yes" on Items 4 or 5 in the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening; or
    2. At Screening, the patient has had 1 or more suicidal attempts within 2 years prior to Screening; or
    3. At Baseline, the patient scores "yes" on Items 4 or 5 in the Suicidal Ideation section of the C-SSRS since the Screening Visit; or
    4. At Screening or Baseline, scores ≥ 4 on Item 10 (suicidal thoughts) on the rater administered Montgomery-Åsberg Depression Rating Scale (MADRS); or
    5. Considered to be an imminent danger to himself/herself or others.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Matching placebo
Drug: Placebo
Matching capsules administered orally, once daily
Experimental: Lumateperone 42 mg
Lumateperone 42 mg capsules
Drug: Lumateperone
Lumateperone 42 mg capsules administered orally, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Young Mania Rating Scale (YMRS)
Time Frame: Week 3
The YMRS is an 11-item, clinician-administered mania rating scale designed to assess the severity of manic symptoms. Four of the YMRS items are rated on a 0 to 8 scale, with the remaining 7 items rated on a 0 to 4 scale. The total score ranges from 0 to 60 with a higher score indicating increased severity of manic symptoms.
Week 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression Scale-Severity (CGI-S)
Time Frame: Week 3
The CGI-S 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).
Week 3

Collaborators and Investigators

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

Sponsor

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)

July 17, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

June 12, 2024

First Submitted That Met QC Criteria

June 12, 2024

First Posted (Actual)

June 17, 2024

Study Record Updates

Last Update Posted (Estimated)

July 1, 2025

Last Update Submitted That Met QC Criteria

June 27, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITI-007-452

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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