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.

Last updated: April 7, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

3

Condition

Depression

Treatment

Cariprazine

Placebo

Clinical Study ID

NCT04777357
3112-301-001
2020-004758-32
  • Ages 10-17
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants with Diagnostic and Statistical Manual of Mental Disorders, FifthEdition (DSM-5) primary diagnosis of bipolar I disorder as confirmed by KiddieSchedule for Affective Disorders and Schizophrenia for School-Age Children-Presentand 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 andVisit 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) atVisit 1 and Visit 2.

Exclusion

Exclusion Criteria:

  • Participants with DSM-5 diagnosis of schizophrenia, schizoaffective disorder,schizophreniform disorder, brief psychotic disorder, psychotic disorder due toanother medical condition, PTSD, antisocial personality disorder, or borderlinepersonality disorder.

  • Participant has a history of meeting DSM-5 diagnosis for any substance-relateddisorder (except caffeine- and tobacco-related) within the 3 months before ScreeningVisit 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, ordocumented 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 thatpredisposes to seizures.

  • Participant requires concomitant treatment with moderate or strong CYP3A4 inhibitorsor with any CYP3A4 inducers.

  • Participant requires concomitant treatment with any prohibited medication,supplement, or herbal product, including any psychotropic drug or any drug withpsychotropic activity or with a potentially psychotropic component.

  • Use of a depot antipsychotic within 2 cycles of their respective dosing intervalprior 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, retinaldetachment, intraocular surgery, laser treatment, glaucoma, cataracts, or clinicallysignificant ocular trauma (with the exception of refractive errors).

Study Design

Total Participants: 380
Treatment Group(s): 2
Primary Treatment: Cariprazine
Phase: 3
Study Start date:
April 28, 2021
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • MHAT Targovishte /ID# 226262

    Targovishte, 7700
    Bulgaria

    Site Not Available

  • Diagnostic consultative center Mladost M /ID# 226291

    Varna, 9020
    Bulgaria

    Site Not Available

  • Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 229417

    Gdansk, Pomorskie 80-546
    Poland

    Site Not Available

  • Zachodniopomorski Instytut Psychoterapii /ID# 228218

    Szczecin, Zachodniopomorskie 70-486
    Poland

    Site Not Available

  • Clinical Research Center /ID# 228219

    Poznan, 60-848
    Poland

    Site Not Available

  • Dr. Samuel Sanchez PSC /ID# 245952

    Caguas, 00727
    Puerto Rico

    Active - Recruiting

  • GCM Medical Group PSC /ID# 245951

    San Juan, 00917-3104
    Puerto Rico

    Active - Recruiting

  • Asociatia Comunitatea Oamenilor /ID# 226514

    Craiova, Dolj 200157
    Romania

    Site Not Available

  • Clinica de Neuropsihiatrie Infantila Timisoara /Id# 226347

    Timisoara, Timis 300329
    Romania

    Site Not Available

  • Institutul de Psihiatrie Socola Iasi /ID# 226200

    Iasi, 700282
    Romania

    Site Not Available

  • City Psychiatric Hospital of Akhangelsk /ID# 226325

    Arkhangelsk, Amurskaya Oblast 163530
    Russian Federation

    Site Not Available

  • Clinica of Glazunova /ID# 229416

    Krasnodar, Krasnodarskiy Kray 350051
    Russian Federation

    Completed

  • Orenburg Regional Clinical Psychiatric Hospital #1 /ID# 226462

    Orenburg, Orenburgskaya Oblast 460006
    Russian Federation

    Completed

  • Psychotherapeutics Center Podderzhka /ID# 226348

    Stavropol, Stavropol Skiy Kray 355029
    Russian Federation

    Completed

  • Kazan State Medical University /ID# 239866

    Kazan, Tatarstan, Respublika 420012
    Russian Federation

    Site Not Available

  • Central Clinical Psychiatric Hospital /ID# 226381

    Moscow, 127083
    Russian Federation

    Completed

  • Scientific Centre of Personalized Medicine /ID# 226380

    Moscow, 105082
    Russian Federation

    Completed

  • Clinical Psychiatry Hospital #1 of Nizhniy Novgorod /ID# 226226

    Nizhny Novgorod, 603155
    Russian Federation

    Completed

  • I. I. Skvortsov-Stepanov Psychiatric Hospital #3 /ID# 226325

    Saint Petersburg, 197341
    Russian Federation

    Site Not Available

  • Psychiatric hospital #1 /ID# 226516

    Saint-Petersburg, 190121
    Russian Federation

    Site Not Available

  • Medgard Clinic /ID# 228598

    Saratov, 410028
    Russian Federation

    Completed

  • Saratov City Clinical Hospital #2 n.a. V. I. Razumovsky /ID# 226222

    Saratov, 410028
    Russian Federation

    Completed

  • National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 226515

    St. Petersburg, 192019
    Russian Federation

    Completed

  • Psychiatric hospital #1 /ID# 226516

    St. Petersburg, 190121
    Russian Federation

    Completed

  • University Clinical Center Kragujevac /ID# 229138

    Kragujevac, Sumadijski Okrug 34000
    Serbia

    Site Not Available

  • Clinical Center Vojvodina /ID# 226521

    Novi Sad, Vojvodina 21000
    Serbia

    Site Not Available

  • Clinic of Neurology and Psychiatry for Children and Youth /ID# 226513

    Belgrade, 11000
    Serbia

    Site Not Available

  • Center for mental health protection, Clinical Centre Nis /ID# 229137

    Nis, 18000
    Serbia

    Site Not Available

  • SIC Institute of Health Care for Children and Adolescents of the NAMS of Ukraine /ID# 226506

    Kharkiv, 61153
    Ukraine

    Site Not Available

  • CNE of LOR Lviv Regional Clinical Psychiatric Hospital /ID# 226461

    Lviv, 79021
    Ukraine

    Site Not Available

  • MNCE Odesa Regional Medical Center for Mental Health /ID# 226231

    Odesa, 65006
    Ukraine

    Site Not Available

  • The University of Alabama at Birmingham /ID# 227074

    Birmingham, Alabama 35233-1718
    United States

    Site Not Available

  • Pillar Clinical Research /ID# 226504

    Bentonville, Arkansas 72712
    United States

    Completed

  • Advanced Research Center /ID# 227073

    Anaheim, California 92805
    United States

    Active - Recruiting

  • Care Access Research /ID# 226316

    Beverly Hills, California 90212
    United States

    Completed

  • ProScience Research Group /ID# 226223

    Culver City, California 90230-6632
    United States

    Completed

  • National Institute of Clinical Research - Garden Grove /ID# 262835

    Garden Grove, California 92844
    United States

    Active - Recruiting

  • Alliance for Research - Long Beach /ID# 226522

    Long Beach, California 90807
    United States

    Completed

  • Duplicate_Alliance for Research - Long Beach /ID# 226522

    Long Beach, California 90807
    United States

    Completed

  • ATP Clinical Research- Orange /ID# 253719

    Orange, California 92868
    United States

    Active - Recruiting

  • CHOC Children's Hospital /ID# 260298

    Orange, California 92868-4203
    United States

    Active - Recruiting

  • Prospective Research Innovations Inc /ID# 240774

    Rancho Cucamonga, California 91730
    United States

    Completed

  • University of California, San Diego Department of Psychiatry /ID# 226463

    San Diego, California 92103-8229
    United States

    Completed

  • Lumos Clinical Research Center /ID# 262805

    San Jose, California 95124-4108
    United States

    Active - Recruiting

  • Pacific Clinical Research Management Group /ID# 227075

    Upland, California 91786
    United States

    Active - Recruiting

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

    Doral, Florida 33122
    United States

    Active - Recruiting

  • Galiz Research - Palmetto Medical Plaza /ID# 226518

    Hialeah, Florida 33016
    United States

    Site Not Available

  • Advanced Research Institute of Miami /ID# 228222

    Homestead, Florida 33030-4613
    United States

    Active - Recruiting

  • Columbus Clinical Services, Llc /Id# 229792

    Miami, Florida 33125-5114
    United States

    Active - Recruiting

  • Florida Research Center, Inc. /ID# 240775

    Miami, Florida 33174
    United States

    Active - Recruiting

  • G+C Research Group, LLC /ID# 261399

    Miami, Florida 33126-2018
    United States

    Active - Recruiting

  • South Florida Research Ph I-IV /ID# 240778

    Miami Springs, Florida 33166-7225
    United States

    Completed

  • Medical Research Group of Central Florida /ID# 256757

    Orange City, Florida 32763
    United States

    Active - Recruiting

  • APG Research, LLC /ID# 226519

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • Panhandle Research and Medical Clinic, LLC /ID# 268522

    Pensacola, Florida 32502
    United States

    Active - Recruiting

  • D&H Tamarac Research Center /ID# 250434

    Tamarac, Florida 33321-2979
    United States

    Active - Recruiting

  • University of South Florida /ID# 246508

    Tampa, Florida 33612-2201
    United States

    Active - Recruiting

  • University of South Florida- Neuroscience Institute /ID# 246508

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • Atlanta Center for Medical Research /ID# 226480

    Atlanta, Georgia 30331
    United States

    Active - Recruiting

  • CenExcel iResearch LLC /ID# 228695

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • Atlanta Behavioral Research, LLC /ID# 226486

    Dunwoody, Georgia 30338
    United States

    Active - Recruiting

  • Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 226371

    Stockbridge, Georgia 30281
    United States

    Completed

  • Ascension St. Elizabeth /ID# 240772

    Chicago, Illinois 60622
    United States

    Completed

  • Baber Research Group /ID# 232279

    Naperville, Illinois 60563-6502
    United States

    Completed

  • Indiana University /ID# 260705

    Indianapolis, Indiana 46202-3082
    United States

    Active - Recruiting

  • Benchmark Research /ID# 260714

    Shreveport, Louisiana 71101-4603
    United States

    Active - Recruiting

  • The Kennedy Krieger Institute /ID# 226509

    Baltimore, Maryland 21205
    United States

    Active - Recruiting

  • Med Clinical Research Partners LLC /ID# 240773

    Irvington, New Jersey 07111
    United States

    Active - Recruiting

  • NeuroCognitive and Behavioral Institute, Inc /ID# 227077

    Mount Arlington, New Jersey 07856-1315
    United States

    Completed

  • Jersey Shore University Medical Center /ID# 226327

    Neptune, New Jersey 07753
    United States

    Site Not Available

  • UB Department of Psychiatry /ID# 226373

    Buffalo, New York 14215
    United States

    Active - Recruiting

  • Finger Lakes Clinical Research /ID# 228548

    Rochester, New York 14618-1609
    United States

    Site Not Available

  • New Dawn Psychiatric Services PLLC /ID# 229782

    Kinston, North Carolina 28501-1603
    United States

    Active - Recruiting

  • Wake Forest Baptist Medical Center /ID# 231643

    Winston-Salem, North Carolina 27157-0001
    United States

    Site Not Available

  • Quest Therapeutics of Avon Lake /ID# 226349

    Avon Lake, Ohio 44012
    United States

    Completed

  • University of Cincinnati /ID# 226465

    Cincinnati, Ohio 45219
    United States

    Completed

  • CincyScience /ID# 226318

    West Chester, Ohio 45069
    United States

    Active - Recruiting

  • Cutting Edge Research Group /ID# 240777

    Oklahoma City, Oklahoma 73116-1423
    United States

    Completed

  • IPS Research Company /ID# 227072

    Oklahoma City, Oklahoma 73106
    United States

    Completed

  • Paradigm Research Professionals /ID# 260719

    Oklahoma City, Oklahoma 73116
    United States

    Completed

  • SP Research, PLLC /ID# 259428

    Oklahoma City, Oklahoma 73112-8729
    United States

    Active - Recruiting

  • Sooner Clinical Research /ID# 226384

    Oklahoma City, Oklahoma 73116
    United States

    Active - Recruiting

  • BioBehavioral Research of Austin /ID# 227076

    Austin, Texas 78759
    United States

    Completed

  • Beaumont Psychiatric Clinic /ID# 267484

    Beaumont, Texas 77706
    United States

    Active - Recruiting

  • Independent Research Center /ID# 270050

    Coppell, Texas 75019
    United States

    Active - Recruiting

  • Relaro Medical Trials /ID# 227156

    Dallas, Texas 75243
    United States

    Active - Recruiting

  • Earle Research /ID# 253782

    Friendswood, Texas 77546
    United States

    Active - Recruiting

  • McGovern Medical School /ID# 240779

    Houston, Texas 77054
    United States

    Completed

  • Red Oak Psychiatry Associates /ID# 240776

    Houston, Texas 77090-2641
    United States

    Completed

  • Southwest Biomed Research Center LLC /ID# 226340

    Houston, Texas 77063
    United States

    Completed

  • Livingspring Family Medical Center /ID# 262706

    Mansfield, Texas 76063-5622
    United States

    Active - Recruiting

  • AIM Trials /ID# 226367

    Plano, Texas 75093
    United States

    Active - Recruiting

  • Perceptive Pharma Research /ID# 262219

    Richmond, Texas 77407
    United States

    Active - Recruiting

  • Family Psychiatry of The Woodlands /ID# 226290

    The Woodlands, Texas 77381
    United States

    Active - Recruiting

  • Pantheon Clinical Research /ID# 270879

    Bountiful, Utah 84010
    United States

    Active - Recruiting

  • Core Clinical Research /ID# 226374

    Everett, Washington 98201
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.