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A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.

AbbVie · NCT04777357

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 10–17 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
380
US sites recruiting
31
Study start
April 28, 2021
Record last updated
July 27, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States. The treatment of the depressive episodes of bipolar disorder in the pediatric population has not been as widely studied as the treatment of depressive episodes in bipolar disorder in adults, therefore pharmacotherapeutic options are limited. Given the change in disease state and safety demonstrated in adults with depressive episodes associated with bipolar I disorder, the purpose of this study is to evaluate the change in disease state and safety of cariprazine in the treatment of depressive episodes associated with bipolar I disorder in the pediatric population.

Cariprazine is an approved drug for the treatment of depressive episodes in adult participants with bipolar I disorder. Study doctors put participants in 1 of 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 380 Participants ages 10-17 years with bipolar I disorder will be enrolled in approximately 60 sites worldwide.

Participants receiving the study drug will receive Dose A or B of Cariprazine based on age and weight. At Week 3, participants with insufficient response will have their dose increased to Dose B or Dose C, while participants with sufficient response will continue receiving the Dose A or B for the remainder of the treatment period. The treatment period will be followed by a safety follow-up (SFU) period for 4 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Being studied: Cariprazine; Placebo

Conditions: Depression; Bipolar I Disorder

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Participants with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) primary diagnosis of bipolar I disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).
  • Current depressive episode is more than 2 weeks and less than 12 months in duration.
  • Participant has a lifetime history of at least one manic episode.
  • Children's Depression Rating Scale - Revised (CDRS-R) score > = 45 at Visit 1 and Visit 2.
  • Young-Mania Rating Scale (YMRS) score \< = 12 with YMRS Item 1 (elevated mood) score \< = 2 at Visit 1 and Visit 2.
  • Clinical Global Impression-Severity (CGI-S) scale score of > = 4 (moderately ill) at Visit 1 and Visit 2.

Exclusion Criteria

  • Participants with DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder due to another medical condition, PTSD, antisocial personality disorder, or borderline personality disorder.
  • Participant has a history of meeting DSM-5 diagnosis for any substance-related disorder (except caffeine- and tobacco-related) within the 3 months before Screening Visit 1.
  • History of serotonin syndrome or neuroleptic malignant syndrome.
  • Four or more episodes of a mood disturbance within the 12 months before Visit 1.
  • DSM-5 diagnosis of intellectual disability (IQ \< 70), autism spectrum disorders, or documented history of chromosomal disorder with developmental impairment.
  • History of seizures, with the exception of febrile seizures.
  • Significant head trauma, history of tumor of the CNS, or any other condition that predisposes to seizures.
  • Participant requires concomitant treatment with moderate or strong CYP3A4 inhibitors or with any CYP3A4 inducers.
  • Participant requires concomitant treatment with any prohibited medication, supplement, or herbal product, including any psychotropic drug or any drug with psychotropic activity or with a potentially psychotropic component.
  • Use of a depot antipsychotic within 2 cycles of their respective dosing interval prior to Screening Visit 1.
  • Treatment with clozapine in a dose of >= 50 mg/d in the past 2 years.
  • History of or any current ocular disease including, but not limited to, retinal detachment, intraocular surgery, laser treatment, glaucoma, cataracts, or clinically significant ocular trauma (with the exception of refractive errors).

Recruiting US locations

  • Advanced Research Center /ID# 227073

    Anaheim, CA 92805

  • Inland Pyschiatric Medical Group - Chino /ID# 278667

    Chino, CA 91710

  • Accellacare - Long Beach /ID# 279482

    Long Beach, CA 90807

  • CHOC Children's Hospital /ID# 260298

    Orange, CA 92868-4203

  • Inland Psychiatric Medical Group /ID# 274621

    Redlands, CA 92373

  • University of California Davis Health /ID# 268306

    Sacramento, CA 95817

    Site contact: Site Coordinator · 916-734-3574 · cqthai@health.ucdavis.edu

  • Next Level Clinical Trials /ID# 277152

    West Covina, CA 91790

    Site contact: Site Coordinator · 773-424-2430 · jemmanuella@nextleveltrials.com

  • D&H Doral Research Center-Doral /ID# 255458

    Doral, FL 33122

  • Florida Research Center, Inc. /ID# 240775

    Miami, FL 33174

  • Medical Research Group of Central Florida /ID# 256757

    Orange City, FL 32763

  • Nova Psychiatry Inc. /ID# 270892

    Orlando, FL 32803

  • D&H Tamarac Research Center /ID# 250434

    Tamarac, FL 33321-2979

  • CenExcel iResearch LLC /ID# 228695

    Decatur, GA 30030

  • Denali Health Atlanta, LLC /ID# 278167

    Stone Mountain, GA 30083

  • Advanced Quality Medical Research /ID# 272902

    Orland Park, IL 60462

  • Med Clinical Research Partners LLC /ID# 240773

    Irvington, NJ 07111

  • Cleveland Clinic - Cleveland /ID# 276309

    Cleveland, OH 44195

  • CincyScience /ID# 226318

    West Chester, OH 45069

  • Sooner Clinical Research /ID# 226384

    Oklahoma City, OK 73116

  • Beaumont Psychiatric Clinic /ID# 267484

    Beaumont, TX 77706

  • Houston Clinical Trials - Bellaire /ID# 274189

    Bellaire, TX 77401

  • Texas Research Group /ID# 270050

    Coppell, TX 75019

  • Relaro Medical Trials /ID# 227156

    Dallas, TX 75243

  • Earle Research /ID# 253782

    Friendswood, TX 77546

  • Kaleidoscope Clinical Research /ID# 277650

    Houston, TX 77089

    Site contact: Site Coordinator · 832-969-6157 · sekeia.willis@sclamanagement.com

  • Livingspring Family Medical Center /ID# 262706

    Mansfield, TX 76063-5622

  • Aim Trials /ID# 226367

    Plano, TX 75093

    Site contact: Site Coordinator · 214-856-2778

  • Perceptive Pharma Research /ID# 262219

    Richmond, TX 77407

  • Family Psychiatry of The Woodlands /ID# 226290

    The Woodlands, TX 77381

  • Pantheon Clinical Research /ID# 270879

    Bountiful, UT 84010

  • Core Clinical Research /ID# 226374

    Everett, WA 98201

Study contacts (from the official record)

  • ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com
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A Study to Assess Change in Disease Activity and Adverse Events… (NCT04777357) | Bored Studies