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Taking people in United StatesPhase 3

Tests cariprazine for depressive episodes in young people with bipolar I disorder

Tests cariprazine against placebo in people aged 10 to 17 with bipolar I disorder.

Plain-language title generated from the registry record
Registry title: 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.

Key facts

Where
Anaheim, Atlanta, Austin, Avon Lake, Baltimore, Beaumont, Bellaire, Bentonville, Beverly Hills, Bountiful, Buffalo, Chicago, Chino, Cincinnati, Cleveland, Coppell, Culver City, Dallas, Decatur, Doral, Dunwoody, Everett, Friendswood, Garden Grove, Homestead, Houston, Indianapolis, Irvington, Kinston, Long Beach, Mansfield, Miami, Miami Springs, Mount Arlington, Naperville, Oklahoma City, Orange, Orange City, Orland Park, Orlando, Pensacola, Plano, Rancho Cucamonga, Redlands, Richmond, Sacramento, San Diego, San Jose, Shreveport, Stockbridge, Stone Mountain, Tamarac, Tampa, The Woodlands, Upland, West Chester, and West Covina, United StatesSee the 69 sites
Phase
Phase 3

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 10 and 17 years old?

Source: NCT04777357, who can take part

Where in United States

  • Advanced Research Center /ID# 227073Anaheim, United StatesTaking people
  • Atlanta Center for Medical Research /ID# 226480Atlanta, United StatesNo longer taking part
  • BioBehavioral Research of Austin /ID# 227076Austin, United StatesNo longer taking part
  • Quest Therapeutics of Avon Lake /ID# 226349Avon Lake, United StatesNo longer taking part
  • The Kennedy Krieger Institute /ID# 226509Baltimore, United StatesNo longer taking part
  • Beaumont Psychiatric Clinic /ID# 267484Beaumont, United StatesTaking people
  • Houston Clinical Trials - Bellaire /ID# 274189Bellaire, United StatesTaking people
  • Pillar Clinical Research /ID# 226504Bentonville, United StatesNo longer taking part
  • Care Access Research /ID# 226316Beverly Hills, United StatesNo longer taking part
  • Pantheon Clinical Research /ID# 270879Bountiful, United StatesTaking people
  • UB Department of Psychiatry /ID# 226373Buffalo, United StatesNo longer taking part
  • Duplicate_Ascension St. Elizabeth /ID# 240772Chicago, United StatesNo longer taking part
  • Inland Pyschiatric Medical Group - Chino /ID# 278667Chino, United StatesTaking people
  • University of Cincinnati /ID# 226465Cincinnati, United StatesNo longer taking part
  • Cleveland Clinic - Cleveland /ID# 276309Cleveland, United StatesTaking people
  • Texas Research Group /ID# 270050Coppell, United StatesTaking people
  • ProScience Research Group /ID# 226223Culver City, United StatesNo longer taking part
  • Relaro Medical Trials /ID# 227156Dallas, United StatesTaking people
  • CenExcel iResearch LLC /ID# 228695Decatur, United StatesTaking people
  • D&H Doral Research Center-Doral /ID# 255458Doral, United StatesTaking people
  • Atlanta Behavioral Research, LLC /ID# 226486Dunwoody, United StatesNo longer taking part
  • Core Clinical Research /ID# 226374Everett, United StatesTaking people
  • Earle Research /ID# 253782Friendswood, United StatesTaking people
  • National Institute of Clinical Research - Garden Grove /ID# 262835Garden Grove, United StatesNo longer taking part
  • Advanced Research Institute of Miami /ID# 228222Homestead, United StatesNo longer taking part
  • Kaleidoscope Clinical Research /ID# 277650Houston, United StatesTaking people
  • McGovern Medical School /ID# 240779Houston, United StatesNo longer taking part
  • Red Oak Psychiatry Associates /ID# 240776Houston, United StatesNo longer taking part
  • Southwest Biomed Research Center LLC /ID# 226340Houston, United StatesNo longer taking part
  • Indiana University /ID# 260705Indianapolis, United StatesNo longer taking part
  • Med Clinical Research Partners LLC /ID# 240773Irvington, United StatesTaking people
  • New Dawn Psychiatric Services PLLC /ID# 229782Kinston, United StatesNo longer taking part
  • Accellacare - Long Beach /ID# 279482Long Beach, United StatesTaking people
  • Duplicate_Alliance for Research - Long Beach /ID# 226522Long Beach, United StatesNo longer taking part
  • Livingspring Family Medical Center /ID# 262706Mansfield, United StatesTaking people
  • Florida Research Center, Inc. /ID# 240775Miami, United StatesTaking people
  • Columbus Clinical Services, Llc /Id# 229792Miami, United StatesNo longer taking part
  • G+C Research Group, LLC /ID# 261399Miami, United StatesNo longer taking part
  • South Florida Research Ph I-IV /ID# 240778Miami Springs, United StatesNo longer taking part
  • Duplicate_NeuroCognitive and Behavioral Institute, Inc /ID# 227077Mount Arlington, United StatesNo longer taking part
  • Baber Research Group /ID# 232279Naperville, United StatesNo longer taking part
  • Sooner Clinical Research /ID# 226384Oklahoma City, United StatesTaking people
  • Cutting Edge Research Group /ID# 240777Oklahoma City, United StatesNo longer taking part
  • IPS Research Company /ID# 227072Oklahoma City, United StatesNo longer taking part
  • Paradigm Research Professionals /ID# 260719Oklahoma City, United StatesNo longer taking part
  • SP Research, PLLC /ID# 259428Oklahoma City, United StatesNo longer taking part
  • CHOC Children's Hospital /ID# 260298Orange, United StatesTaking people
  • ATP Clinical Research- Orange /ID# 253719Orange, United StatesNo longer taking part
  • Medical Research Group of Central Florida /ID# 256757Orange City, United StatesTaking people
  • Advanced Quality Medical Research /ID# 272902Orland Park, United StatesTaking people
  • Nova Psychiatry Inc. /ID# 270892Orlando, United StatesTaking people
  • APG Research, LLC /ID# 226519Orlando, United StatesNo longer taking part
  • Panhandle Research and Medical Clinic, LLC /ID# 268522Pensacola, United StatesNo longer taking part
  • Aim Trials /ID# 226367Plano, United StatesTaking people
  • Prospective Research Innovations Inc /ID# 240774Rancho Cucamonga, United StatesNo longer taking part
  • Inland Psychiatric Medical Group /ID# 274621Redlands, United StatesTaking people
  • Perceptive Pharma Research /ID# 262219Richmond, United StatesTaking people
  • University of California Davis Health /ID# 268306Sacramento, United StatesTaking people
  • University of California, San Diego Department of Psychiatry /ID# 226463San Diego, United StatesNo longer taking part
  • Lumos Clinical Research Center /ID# 262805San Jose, United StatesNo longer taking part
  • Benchmark Research /ID# 260714Shreveport, United StatesNo longer taking part
  • Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 226371Stockbridge, United StatesNo longer taking part
  • Denali Health Atlanta, LLC /ID# 278167Stone Mountain, United StatesTaking people
  • D&H Tamarac Research Center /ID# 250434Tamarac, United StatesTaking people
  • University of South Florida- Neuroscience Institute /ID# 246508Tampa, United StatesNo longer taking part
  • Family Psychiatry of The Woodlands /ID# 226290The Woodlands, United StatesTaking people
  • Pacific Clinical Research Management Group /ID# 227075Upland, United StatesNo longer taking part
  • CincyScience /ID# 226318West Chester, United StatesTaking people
  • Next Level Clinical Trials /ID# 277152West Covina, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
AbbVie
Trial code
NCT04777357
Record updated
27 July 2026
Original description
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.Read full original descriptionShow less

A 6-week, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Cariprazine in Pediatric Subjects (10 to 17 Years of Age) in the Treatment of Depressive Episodes Associated With Bipolar I Disorder

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.

Inclusion: 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: 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; Four or more episodes of a mood disturbance within the 12 months before Visit 1; 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; 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; History of serotonin syndrome or neuroleptic malignant syndrome; 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; 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).

ClinicalTrials.gov NCT04777357