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NCT04777357PHASE3Recruiting

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

Start Date

4/28/2021

Completion Date

3/1/2027

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

Age Range: 10 years to 17 years

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).

Interventions

DRUG

Cariprazine

DRUG

Placebo

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Conditions

DepressionBipolar I Disorder

Locations

Pillar Clinical Research /ID# 226504

Bentonville, Arkansas 72712

United States

Advanced Research Center /ID# 227073

Anaheim, California 92805

United States

Care Access Research /ID# 226316

Beverly Hills, California 90212

United States

Inland Pyschiatric Medical Group - Chino /ID# 278667

Chino, California 91710

United States

ProScience Research Group /ID# 226223

Culver City, California 90230-6632

United States

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

Garden Grove, California 92844

United States

Accellacare - Long Beach /ID# 279482

Long Beach, California 90807

United States

Duplicate_Alliance for Research - Long Beach /ID# 226522

Long Beach, California 90807

United States

CHOC Children's Hospital /ID# 260298

Orange, California 92868-4203

United States

ATP Clinical Research- Orange /ID# 253719

Orange, California 92868

United States

Prospective Research Innovations Inc /ID# 240774

Rancho Cucamonga, California 91730

United States

Inland Psychiatric Medical Group /ID# 274621

Redlands, California 92373

United States

University of California Davis Health /ID# 268306

Sacramento, California 95817

United States

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

San Diego, California 92103-8229

United States

Lumos Clinical Research Center /ID# 262805

San Jose, California 95124-4108

United States

Pacific Clinical Research Management Group /ID# 227075

Upland, California 91786

United States

Next Level Clinical Trials /ID# 277152

West Covina, California 91790

United States

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

Doral, Florida 33122

United States

Advanced Research Institute of Miami /ID# 228222

Homestead, Florida 33030-4613

United States

Columbus Clinical Services, Llc /Id# 229792

Miami, Florida 33125

United States

G+C Research Group, LLC /ID# 261399

Miami, Florida 33126-2018

United States

Florida Research Center, Inc. /ID# 240775

Miami, Florida 33174

United States

South Florida Research Ph I-IV /ID# 240778

Miami Springs, Florida 33166-7225

United States

Medical Research Group of Central Florida /ID# 256757

Orange City, Florida 32763

United States

APG Research, LLC /ID# 226519

Orlando, Florida 32803

United States

Nova Psychiatry Inc. /ID# 270892

Orlando, Florida 32803

United States

Panhandle Research and Medical Clinic, LLC /ID# 268522

Pensacola, Florida 32502

United States

D&H Tamarac Research Center /ID# 250434

Tamarac, Florida 33321-2979

United States

University of South Florida- Neuroscience Institute /ID# 246508

Tampa, Florida 33613

United States

Atlanta Center for Medical Research /ID# 226480

Atlanta, Georgia 30331

United States

CenExcel iResearch LLC /ID# 228695

Decatur, Georgia 30030

United States

Atlanta Behavioral Research, LLC /ID# 226486

Dunwoody, Georgia 30338

United States

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

Stockbridge, Georgia 30281

United States

Denali Health Atlanta, LLC /ID# 278167

Stone Mountain, Georgia 30083

United States

Duplicate_Ascension St. Elizabeth /ID# 240772

Chicago, Illinois 60622

United States

Baber Research Group /ID# 232279

Naperville, Illinois 60563-6502

United States

Advanced Quality Medical Research /ID# 272902

Orland Park, Illinois 60462

United States

Indiana University /ID# 260705

Indianapolis, Indiana 46202-3082

United States

Benchmark Research /ID# 260714

Shreveport, Louisiana 71101

United States

The Kennedy Krieger Institute /ID# 226509

Baltimore, Maryland 21205

United States

Med Clinical Research Partners LLC /ID# 240773

Irvington, New Jersey 07111

United States

Duplicate_NeuroCognitive and Behavioral Institute, Inc /ID# 227077

Mount Arlington, New Jersey 07856-1315

United States

UB Department of Psychiatry /ID# 226373

Buffalo, New York 14215

United States

New Dawn Psychiatric Services PLLC /ID# 229782

Kinston, North Carolina 28501-1603

United States

Quest Therapeutics of Avon Lake /ID# 226349

Avon Lake, Ohio 44012

United States

University of Cincinnati /ID# 226465

Cincinnati, Ohio 45219

United States

Cleveland Clinic - Cleveland /ID# 276309

Cleveland, Ohio 44195

United States

CincyScience /ID# 226318

West Chester, Ohio 45069

United States

IPS Research Company /ID# 227072

Oklahoma City, Oklahoma 73106

United States

SP Research, PLLC /ID# 259428

Oklahoma City, Oklahoma 73112-8729

United States

Cutting Edge Research Group /ID# 240777

Oklahoma City, Oklahoma 73116-1423

United States

Paradigm Research Professionals /ID# 260719

Oklahoma City, Oklahoma 73116

United States

Sooner Clinical Research /ID# 226384

Oklahoma City, Oklahoma 73116

United States

BioBehavioral Research of Austin /ID# 227076

Austin, Texas 78759

United States

Beaumont Psychiatric Clinic /ID# 267484

Beaumont, Texas 77706

United States

Houston Clinical Trials - Bellaire /ID# 274189

Bellaire, Texas 77401

United States

Texas Research Group /ID# 270050

Coppell, Texas 75019

United States

Relaro Medical Trials /ID# 227156

Dallas, Texas 75243

United States

Earle Research /ID# 253782

Friendswood, Texas 77546

United States

McGovern Medical School /ID# 240779

Houston, Texas 77054

United States

Southwest Biomed Research Center LLC /ID# 226340

Houston, Texas 77063

United States

Kaleidoscope Clinical Research /ID# 277650

Houston, Texas 77089

United States

Red Oak Psychiatry Associates /ID# 240776

Houston, Texas 77090-2641

United States

Livingspring Family Medical Center /ID# 262706

Mansfield, Texas 76063-5622

United States

Aim Trials /ID# 226367

Plano, Texas 75093

United States

Perceptive Pharma Research /ID# 262219

Richmond, Texas 77407

United States

Family Psychiatry of The Woodlands /ID# 226290

The Woodlands, Texas 77381

United States

Pantheon Clinical Research /ID# 270879

Bountiful, Utah 84010

United States

Core Clinical Research /ID# 226374

Everett, Washington 98201

United States

Dr. Samuel Sanchez PSC /ID# 245952

Caguas, 00727

Puerto Rico

GCM Medical Group /ID# 245951

San Juan, 00917-3104

Puerto Rico

Clinica of Glazunova /ID# 229416

Krasnodar, Krasnodarskiy Kray 350051

Russia

Duplicate_Scientific Centre of Personalized Medicine /ID# 226380

Moscow, Moscow 105082

Russia

Duplicate_Central Clinical Psychiatric Hospital /ID# 226381

Moscow, Moscow 127083

Russia

Orenburg Regional Clinical Psychiatric Hospital #1 /ID# 226462

Orenburg, Orenburg Oblast 460006

Russia

Psychotherapeutics Center Podderzhka /ID# 226348

Stavropol, Stavropol Kray 355029

Russia

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

Nizhny Novgorod, 603155

Russia

Psychiatric hospital #1 /ID# 226516

Saint Petersburg, 190121

Russia

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

Saint Petersburg, 192019

Russia

Medgard Clinic /ID# 228598

Saratov, 410028

Russia

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

Saratov, 410028

Russia