Study of Lumateperone in the Treatment of Patients With Bipolar Mania

July 22, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
351

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Bulgaria
      • Burgas, Bulgaria, 8000
        • Clinical Site
      • Kazanlak, Bulgaria, 6100
        • Clinical Site
      • Plovdiv, Bulgaria, 4002
        • Clinical Site
      • Sliven, Bulgaria, 8800
        • Clinical Site
      • Sofia, Bulgaria, 1431
        • Clinical Site
  • Romania
      • Brasov, Romania, 507190
        • Clinical Site
      • Bucharest, Romania, 06022
        • Clinical Site
      • Iași, Romania, 700282
        • Clinical Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Site
      • Kovin, Serbia, 26220
        • Clinical Site
      • Kragujevac, Serbia, 34000
        • Clinical Site
      • Niš, Serbia
        • Clinical Site
      • Novi Kneževac, Serbia
        • Clinical Site
  • United States
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Clinical Site
      • Little Rock, Arkansas, United States, 72211
        • Clinical Site
    • California
      • Anaheim, California, United States, 92805
        • Clinical Site
      • Cerritos, California, United States, 90703
        • Clinical Site
      • Orange, California, United States, 92868
        • Clinical Site
      • Torrance, California, United States, 90504
        • Clinical Site
    • Florida
      • Hialeah, Florida, United States, 33012
        • Clinical Site
      • Miami, Florida, United States, 33122
        • Clinical Site
      • Miami, Florida, United States, 33135
        • Clinical Site
      • Miami, Florida, United States, 33145
        • Clinical Site
      • Miami Lakes, Florida, United States, 33016
        • Clinical Site
      • Miami Lakes, Florida, United States, 33014
        • Clinical Site
      • Tampa, Florida, United States, 33629
        • Clinical Site
      • West Palm Beach, Florida, United States, 33407
        • Clinical Site
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Clinical Site
      • Stockbridge, Georgia, United States, 30281
        • Clinical Site
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Clinical Site
      • Chicago, Illinois, United States, 60641
        • Clinical Site
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • Clinical Site
    • New York
      • Glen Oaks, New York, United States, 11004
        • Clinical Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Clinical Site
    • Texas
      • Richardson, Texas, United States, 75080
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Intra-Cellular Therapies, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Intra-Cellular Therapies, Inc. Clinical Trial, 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 17, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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