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New study tests Cariprazine's safety in kids with mental health conditions

NCT ID NCT04578756

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the long-term safety of cariprazine, a medication, in 310 children and teens with schizophrenia, bipolar I disorder, or autism spectrum disorder. Over 52 weeks, researchers monitored side effects, vital signs, lab results, and movement disorders. The goal was to understand the risks and benefits of using cariprazine for extended periods in young people.

What this could mean

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

Active substance
cariprazine
What this could lead to
If successful, this could confirm that cariprazine is safe enough for long-term use in children and teens with these conditions, helping manage symptoms over time.
What could go wrong
This is an open-label study without a placebo group, so results may be biased. Side effects like movement disorders or suicidal thoughts are possible, and long-term risks are still being studied.

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

310 people

The number who actually took part.

Started

Feb 2021

Finished

Oct 2025

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

5 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: * Participants with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia or bipolar I disorder, or autism spectrum disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL) at the Screening Visit 1 (for de novo subjects, or as previously confirmed in parent study for subjects who completed Study 3112-301-001 or M21-465). * De novo participants must have normal physical examination findings, clinical laboratory test results, and electrocardiogram (ECG) results at Screening Visit 1. Abnormal results must not be clinically significant as determined by the investigator. Participants enrolling after completion of Study M21-465 or 3112-301-001 have had monitoring of laboratory tests, physical examinations, and ECGs at the completion visit of the parent studies. * Participant must have a caregiver (parent or legally authorized representative) who is willing and able to be responsible for safety monitoring of the participant, provide information about the participant's condition, oversee administration of study intervention, and accompany the participant to all study visits. Exclusion Criteria: * Participants with DSM-5-TR diagnosis of major depressive disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition. Participants with ASD that is associated with Rett disorder, fragile-X syndrome, or childhood disintegrative disorder. * Prior DSM-5-TR diagnosis of intellectual disability (IQ \< 70) for schizophrenia and bipolar I disorder participants. Prior DSM-5-TR diagnosis of profound intellectual disability (IQ \< 25) for ASD participants. * Participant has a condition or is in a situation, which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study.

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder bipolar I disorder schizophrenia

As listed by the trial registrant

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

Autism spectrum disorder (ASD) Bipolar I disorder Schizophrenia

Contacts and locations

Locations

  • AIM Trials /ID# 236368

    Plano, Texas, 75093, United States

  • APG Research, LLC /ID# 251153

    Orlando, Florida, 32803, United States

  • ATP Clinical Research- Orange /ID# 257095

    Orange, California, 92868, United States

  • Advanced Research Center /ID# 241903

    Anaheim, California, 92805, United States

  • Advanced Research Institute of Miami /ID# 242505

    Homestead, Florida, 33030-4613, United States

  • Ascension Illinois /ID# 235857

    Hoffman Estates, Illinois, 60169, United States

  • Atlanta Behavioral Research, LLC /ID# 236374

    Dunwoody, Georgia, 30338, United States

  • Atlanta Center for Medical Research /ID# 234698

    Atlanta, Georgia, 30331, United States

  • BioBehavioral Research of Austin /ID# 236479

    Austin, Texas, 78759, United States

  • CHOC Children's Hospital /ID# 251019

    Orange, California, 92868-4203, United States

  • Cedar Health Research /ID# 259364

    Dallas, Texas, 75251-2202, United States

  • CenExcel iResearch LLC /ID# 237391

    Decatur, Georgia, 30030, United States

  • Cincinnati Children's Hospital /ID# 251020

    Cincinnati, Ohio, 45229, United States

  • CincyScience /ID# 236390

    West Chester, Ohio, 45069, United States

  • Columbus Clinical Services, Llc /Id# 234281

    Miami, Florida, 33125, United States

  • Core Clinical Research /ID# 236409

    Everett, Washington, 98201, United States

  • Cutting Edge Research Group /ID# 236664

    Oklahoma City, Oklahoma, 73116-1423, United States

  • D&H Doral Research Center-Doral /ID# 255459

    Doral, Florida, 33122, United States

  • D&H Tamarac Research Center /ID# 250435

    Tamarac, Florida, 33321-2979, United States

  • Dr. Samuel Sanchez PSC /ID# 246047

    Caguas, 00727, Puerto Rico

  • Duplicate_Alliance for Research - Long Beach /ID# 236261

    Long Beach, California, 90807, United States

  • Duplicate_Sandhill Research LLC /ID# 251239

    Lake Mary, Florida, 32746, United States

  • Erie County Medical Center /ID# 237204

    Buffalo, New York, 14215, United States

  • Family Psychiatry of The Woodlands /ID# 236426

    The Woodlands, Texas, 77381, United States

  • Florida Research Center, Inc. /ID# 236515

    Miami, Florida, 33174, United States

  • G+C Research Group, LLC /ID# 261398

    Miami, Florida, 33126-2018, United States

  • GCM Medical Group PSC /ID# 246048

    San Juan, 00917-3104, Puerto Rico

  • Galiz Research- Palmetto Medical Plaza /ID# 236277

    Hialeah, Florida, 33016, United States

  • Harmonex Neuroscience Research /ID# 234938

    Dothan, Alabama, 36303, United States

  • K2 Medical Research - Orlando - South Orlando Avenue /ID# 257528

    Orlando, Florida, 32751, United States

  • Links Clinical Trials /ID# 240975

    Miami, Florida, 33176-3227, United States

  • Med Clinical Research Partners LLC /ID# 236071

    Irvington, New Jersey, 07111, United States

  • New Dawn Psychiatric Services PLLC /ID# 236597

    Kinston, North Carolina, 28501-1603, United States

  • Pacific Clinical Research Management Group /ID# 234377

    Upland, California, 91786, United States

  • Pillar Clinical Research /ID# 236434

    Bentonville, Arkansas, 72712, United States

  • Prospective Research Innovations Inc /ID# 236098

    Rancho Cucamonga, California, 91730, United States

  • Quest Therapeutics of Avon Lake /ID# 235956

    Avon Lake, Ohio, 44012, United States

  • Red Oak Psychiatry Associates /ID# 236602

    Houston, Texas, 77090-2641, United States

  • Sarkis Clinical Trials /ID# 236893

    Gainesville, Florida, 32607, United States

  • South Florida Research Ph I-IV /ID# 237453

    Miami Springs, Florida, 33166-7225, United States

  • University of California, San Diego Department of Psychiatry /ID# 236466

    San Diego, California, 92103-8229, United States

  • University of Cincinnati /ID# 236913

    Cincinnati, Ohio, 45219, United States

More trials for these conditions

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