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Could a new pill ease bipolar depression in young people?

NCT ID NCT06372964

Disease control Sponsor: Intra-Cellular Therapies, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Aug 28, 2026 · Updated 5 times

Summary

This study tests whether the drug lumateperone can safely reduce symptoms of depression in children and teenagers (ages 10 to 17) with bipolar I or II disorder who are currently in a major depressive episode. Participants receive either lumateperone or a placebo daily for several weeks, and researchers measure changes in depression severity using a standard rating scale. The goal is to see if lumateperone offers a new treatment option for young people with bipolar depression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lumateperone
What this could lead to
If successful, this could provide a new treatment option for bipolar depression in children and teenagers.
What could go wrong
This is a Phase 3 trial, but the drug may not prove more effective than placebo. Side effects are possible, and results in adults may not fully apply to younger patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 384 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Oct 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Able to provide consent as follows: * The Legally Authorized Representative (LAR) must provide written, informed consent. * The patient must provide written assent; 2. Male or female patients 10 to 17 years of age, inclusive; 3. Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of bipolar I or bipolar II disorder with a current MDE without psychosis as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL); 4. Subject has a lifetime history of at least one manic or hypomanic episode. 5. Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration; 6. CDRS-R total score ≥ 45 with ≥ 5 on Item 11 (depressed feelings) at Screening and Baseline; 7. Young Mania Rating Scale (YMRS) score ≤ 15 (with YMRS Item 1 \[elevated mood\] score ≤ 2) at Screening and Baseline. Exclusion Criteria: 1. Has a primary psychiatric diagnosis other than bipolar I or bipolar II disorder. Exception includes: * Attention deficit hyperactivity disorder (ADHD). If a subject is taking medications for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study. 2. Intellectual disability based on Investigator opinion and DSM-5 criteria 3. Patient has been hospitalized for a bipolar manic episode within the 30 days prior to randomization; 4. Demonstrates a ≥ 25% decrease (improvement) in the CDRS-R total score between Screening and Baseline visits, or the CDRS-R is below 45 at Baseline; 5. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or 1. At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit; 2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or 3. At Screening or Baseline, scores \> 3 on Item 13 (suicidal ideation) on the CDRS-R; or 4. The patient is considered to be an imminent danger to him/herself or others.

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Conditions

The condition(s) this trial relates to.

bipolar depression bipolar disorder bipolar I disorder bipolar II disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bipolar depression

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    48 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AP Medical Research

    SUSPENDED

    Miami, Florida, 33165, United States

  • APG Research LLC

    RECRUITING

    Orlando, Florida, 32803, United States

  • Advanced Discovery Research

    COMPLETED

    Atlanta, Georgia, 30318, United States

  • Advanced Research Center, Inc

    RECRUITING

    Anaheim, California, 92805, United States

  • Advanced Research Institute of Miami

    SUSPENDED

    Homestead, Florida, 33033, United States

  • Alivation Research LLC

    RECRUITING

    Lincoln, Nebraska, 68526, United States

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    RECRUITING

    Chicago, Illinois, 60611, United States

  • BioBehavioral Research of Austin PC

    COMPLETED

    Austin, Texas, 78759, United States

  • Care Research Center Inc

    RECRUITING

    Miami, Florida, 33130, United States

  • CenExeli Research LLC

    RECRUITING

    Atlanta, Georgia, 30030, United States

  • CenExeli Research LLC 1

    RECRUITING

    Savannah, Georgia, 31405, United States

  • Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.

    COMPLETED

    Bogotá, 111166, Colombia

  • Centro de Investigaciones y Proyectos en Neurociencias CIPNA

    RECRUITING

    Barranquilla, 080020, Colombia

  • Charak Center for Health and Wellness

    RECRUITING

    Garfield Heights, Ohio, 44125, United States

  • Chopda Medicare & Research Centre

    SUSPENDED

    Nashik, 422005, India

  • Clinic of Neurology and Psychiatry for Children and Youth

    ACTIVE_NOT_RECRUITING

    Belgrade, 11000, Serbia

  • Clinical Center of Vojvodina

    SUSPENDED

    Novi Sad, 21000, Serbia

  • Columbus Clinical Services LLC

    SUSPENDED

    Miami, Florida, 33125, United States

  • Core Clinical Research

    RECRUITING

    Everett, Washington, 98201, United States

  • Cutting Edge Research Group

    COMPLETED

    Oklahoma City, Oklahoma, 73116, United States

  • Deva Institute of Healthcare And Research Pvt Ltd

    SUSPENDED

    Varanasi, 221005, India

  • Empresa Social del Estado Hospital Mental de Antioquia Maria Upegui HOMO

    RECRUITING

    Bello, 051053, Colombia

  • Envision Trials LLC

    RECRUITING

    Miami, Florida, 33166, United States

  • GTL Medical and Research Group

    COMPLETED

    Miami, Florida, 33173, United States

  • Haidar Almhana Nieding

    COMPLETED

    Avon Lake, Ohio, 44012, United States

  • Harmonex Neuroscience Research

    RECRUITING

    Dothan, Alabama, 36303, United States

  • Health Synergy Clinical Research

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • HealthMed Clinical Center Inc

    RECRUITING

    Miami, Florida, 33134, United States

  • Indiana University

    COMPLETED

    Indianapolis, Indiana, 46202, United States

  • Inland Psychiatric Medical Group Inc

    RECRUITING

    Redlands, California, 92373, United States

  • Institute of Mental Health Serbia

    ACTIVE_NOT_RECRUITING

    Belgrade, 11000, Serbia

  • Kaleidoscope Clinical Research

    RECRUITING

    Houston, Texas, 77089, United States

  • Links Clinical Trials

    RECRUITING

    Miami, Florida, 33176, United States

  • MCB Clinical Research Centers LLC

    COMPLETED

    Colorado Springs, Colorado, 80910, United States

  • MTP Psychiatry LLC

    COMPLETED

    Baltimore, Maryland, 21229, United States

  • Midwest Research Group

    RECRUITING

    Saint Charles, Missouri, 63304, United States

  • NYU Child Study Center

    RECRUITING

    New York, New York, 10016, United States

  • Neurobehavioral Medicine Group

    RECRUITING

    Bloomfield Hills, Michigan, 48302, United States

  • New Med Research Inc

    RECRUITING

    Miami Gardens, Florida, 33056, United States

  • Next Level Clinical Trials, LLC

    RECRUITING

    West Covina, California, 91790, United States

  • North Pointe Psychiatry

    COMPLETED

    Flower Mound, Texas, 76028, United States

  • Northwest Clinical Research Center

    RECRUITING

    Bellevue, Washington, 98007, United States

  • Ocean Blue Medical Research Center Inc.

    COMPLETED

    Miami, Florida, 33144, United States

  • Perceptive Pharma Research

    RECRUITING

    Richmond, Texas, 77407, United States

  • Pillar Clinical Research, LLC

    RECRUITING

    Little Rock, Arkansas, 72204, United States

  • Psynapsis Salud Mental S.A.

    SUSPENDED

    Pereira, 660002, Colombia

  • REX Clinical Trials LLC

    RECRUITING

    Beaumont, Texas, 77701, United States

  • Ratandeep Surgical Hospital And Endoscopy Clinic

    SUSPENDED

    Ahmedabad, 380008, India

  • Red Oak Psychiatry Associates

    RECRUITING

    Houston, Texas, 77090, United States

  • Revive Research Institute

    RECRUITING

    Elgin, Illinois, 60123, United States

  • Riveldi Biomedical Research

    RECRUITING

    Miami Lakes, Florida, 33014, United States

  • Royal Palm Clinical Research

    SUSPENDED

    Fort Myers, Florida, 33901, United States

  • SP Research, PLLC (dba Rivus Wellness & Research Institute)

    RECRUITING

    Oklahoma City, Oklahoma, 73112, United States

  • Salveo Integrative Health Inc

    COMPLETED

    Lawrenceville, Georgia, 30046, United States

  • Society for Psychiatric Update and Research Shanti Nursing Home

    SUSPENDED

    Aurangabad, 431005, India

  • Sooner Clinical Research

    RECRUITING

    Oklahoma City, Oklahoma, 73116, United States

  • SouthGen Clinical Research LLC

    COMPLETED

    Miami, Florida, 33186, United States

  • The Angel Medical Research Corporation

    RECRUITING

    Miami Gardens, Florida, 33169, United States

  • The University of Texas at Austin

    RECRUITING

    Austin, Texas, 78701, United States

  • UC Davis Health System

    RECRUITING

    Sacramento, California, 95817, United States

  • United Research Institute

    COMPLETED

    Hialeah, Florida, 33012, United States

  • University Clinical Center NIS

    ACTIVE_NOT_RECRUITING

    Niš, 18000, Serbia

  • University of California San Diego Medical Center

    COMPLETED

    San Diego, California, 92103, United States

  • University of Cincinnati Medical Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23220, United States

  • Vital Care Research

    SUSPENDED

    Miami, Florida, 33122, United States

  • Washington University School of Medicine Child and Adolescent Psychiatry Clinic

    COMPLETED

    St Louis, Missouri, 63110, United States

  • Westlake America Clinic

    COMPLETED

    Westlake, Ohio, 44145, United States

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