Please sign in to follow a disease.

Could a new pill ease bipolar depression in young people?

NCT ID NCT06372964

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

First seen Jul 07, 2026 · Last updated Jul 24, 2026 · Updated 3 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.

Get updates

Get notified about this study

Our safety recommendation!

By submitting, you agree to our Terms of use

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

Contacts and locations

Show contact details

Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

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
RECRUITING

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.
RECRUITING

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.