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RECRUITING

NCT04777357

PHASE3

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.

Sponsor: AbbVie

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

10 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

380

Start Date

2021-04-28

Completion Date

2027-03

Last Updated

2026-04-01

Healthy Volunteers

Conditions

Depression Bipolar I Disorder

Interventions

DRUG

Cariprazine

Oral Capsule

DRUG

Placebo

Oral Capsule

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).

Locations (80)

Pillar Clinical Research /ID# 226504

Bentonville, Arkansas, United States

Advanced Research Center /ID# 227073

Anaheim, California, United States

Care Access Research /ID# 226316

Beverly Hills, California, United States

Inland Pyschiatric Medical Group - Chino /ID# 278667

Chino, California, United States

ProScience Research Group /ID# 226223

Culver City, California, United States

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

Garden Grove, California, United States

Duplicate_Alliance for Research - Long Beach /ID# 226522

Long Beach, California, United States

CHOC Children's Hospital /ID# 260298

Orange, California, United States

ATP Clinical Research- Orange /ID# 253719

Orange, California, United States

Prospective Research Innovations Inc /ID# 240774

Rancho Cucamonga, California, United States

Inland Psychiatric Medical Group /ID# 274621

Redlands, California, United States

University of California Davis Health /ID# 268306

Sacramento, California, United States

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

San Diego, California, United States

Lumos Clinical Research Center /ID# 262805

San Jose, California, United States

Pacific Clinical Research Management Group /ID# 227075

Upland, California, United States

Next Level Clinical Trials /ID# 277152

West Covina, California, United States

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

Doral, Florida, United States

Advanced Research Institute of Miami /ID# 228222

Homestead, Florida, United States

Columbus Clinical Services, Llc /Id# 229792

Miami, Florida, United States

G+C Research Group, LLC /ID# 261399

Miami, Florida, United States

Florida Research Center, Inc. /ID# 240775

Miami, Florida, United States

South Florida Research Ph I-IV /ID# 240778

Miami Springs, Florida, United States

Medical Research Group of Central Florida /ID# 256757

Orange City, Florida, United States

APG Research, LLC /ID# 226519

Orlando, Florida, United States

Nova Psychiatry Inc. /ID# 270892

Orlando, Florida, United States

Panhandle Research and Medical Clinic, LLC /ID# 268522

Pensacola, Florida, United States

D&H Tamarac Research Center /ID# 250434

Tamarac, Florida, United States

University of South Florida- Neuroscience Institute /ID# 246508

Tampa, Florida, United States

Atlanta Center for Medical Research /ID# 226480

Atlanta, Georgia, United States

CenExcel iResearch LLC /ID# 228695

Decatur, Georgia, United States

Atlanta Behavioral Research, LLC /ID# 226486

Dunwoody, Georgia, United States

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

Stockbridge, Georgia, United States

Denali Health Atlanta, LLC /ID# 278167

Stone Mountain, Georgia, United States

Duplicate_Ascension St. Elizabeth /ID# 240772

Chicago, Illinois, United States

Baber Research Group /ID# 232279

Naperville, Illinois, United States

Advanced Quality Medical Research /ID# 272902

Orland Park, Illinois, United States

Indiana University /ID# 260705

Indianapolis, Indiana, United States

Benchmark Research /ID# 260714

Shreveport, Louisiana, United States

The Kennedy Krieger Institute /ID# 226509

Baltimore, Maryland, United States

Med Clinical Research Partners LLC /ID# 240773

Irvington, New Jersey, United States

Duplicate_NeuroCognitive and Behavioral Institute, Inc /ID# 227077

Mount Arlington, New Jersey, United States

UB Department of Psychiatry /ID# 226373

Buffalo, New York, United States

New Dawn Psychiatric Services PLLC /ID# 229782

Kinston, North Carolina, United States

Quest Therapeutics of Avon Lake /ID# 226349

Avon Lake, Ohio, United States

University of Cincinnati /ID# 226465

Cincinnati, Ohio, United States

Cleveland Clinic - Cleveland /ID# 276309

Cleveland, Ohio, United States

CincyScience /ID# 226318

West Chester, Ohio, United States

IPS Research Company /ID# 227072