Recruiting
Phase 3

Cariprazine

Sponsor:

AbbVie

Code:

NCT04777357

Conditions

Depression

Bipolar I Disorder

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

Interventions

Cariprazine

Placebo

Study Details

Brief 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.

Conditions

Depression

Bipolar I Disorder

Study ID

NCT04777357

Start date

Apr 28, 2021

Status verified date

Jul, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

380 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Participants will receive Placebo over a 6 week treatment period.

experimental: Cariprazine

Participants will receive flexible dose Cariprazine over a 6 week treatment period.

Interventions

Cariprazine

Oral Capsule

Placebo

Oral Capsule

Primary outcome measure

  • Number of Participants with Adverse Events [ Time Frame: Baseline (Week 0) to Week 10 ]
  • Abnormal Change from Baseline in Vital Signs [ Time Frame: Baseline (Week 0) to Week 10 ]
  • Number of Participants with Incidence of Abnormal Clinical Laboratory Test Results [ Time Frame: Baseline (Week 0) to Week 6 ]
  • Change in Electrocardiogram (ECG) [ Time Frame: Baseline (Week 0) to Week 6 ]
  • Change From Baseline in Simpson-Angus Scale (SAS) [ Time Frame: Baseline (Week 0) to Week 6 ]
  • Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline (Week 0) to Week 10 ]
  • Change From Baseline in Barnes Akathisia Rating Scale (BARS) [ Time Frame: Baseline (Week 0) to Week 6 ]
  • Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline (Week 0) to Week 6 ]
  • Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score [ Time Frame: Baseline (Week 0) to Week 6 ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Advanced Research Center /ID# 227073

Recruiting

Anaheim, California, United States, 92805

Inland Pyschiatric Medical Group - Chino /ID# 278667

Recruiting

Chino, California, United States, 91710

Accellacare - Long Beach /ID# 279482

Recruiting

Long Beach, California, United States, 90807

CHOC Children's Hospital /ID# 260298

Recruiting

Orange, California, United States, 92868-4203

Inland Psychiatric Medical Group /ID# 274621

Recruiting

Redlands, California, United States, 92373

University of California Davis Health /ID# 268306

Recruiting

Sacramento, California, United States, 95817

Contacts

Site Coordinator

916-734-3574cqthai@health.ucdavis.edu

Next Level Clinical Trials /ID# 277152

Recruiting

West Covina, California, United States, 91790

Contacts

Site Coordinator

773-424-2430jemmanuella@nextleveltrials.com

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

Recruiting

Doral, Florida, United States, 33122

Florida Research Center, Inc. /ID# 240775

Recruiting

Miami, Florida, United States, 33174

Medical Research Group of Central Florida /ID# 256757

Recruiting

Orange City, Florida, United States, 32763

Nova Psychiatry Inc. /ID# 270892

Recruiting

Orlando, Florida, United States, 32803

D&H Tamarac Research Center /ID# 250434

Recruiting

Tamarac, Florida, United States, 33321-2979

CenExcel iResearch LLC /ID# 228695

Recruiting

Decatur, Georgia, United States, 30030

Denali Health Atlanta, LLC /ID# 278167

Recruiting

Stone Mountain, Georgia, United States, 30083

Advanced Quality Medical Research /ID# 272902

Recruiting

Orland Park, Illinois, United States, 60462

Med Clinical Research Partners LLC /ID# 240773

Recruiting

Irvington, New Jersey, United States, 07111

Cleveland Clinic - Cleveland /ID# 276309

Recruiting

Cleveland, Ohio, United States, 44195

CincyScience /ID# 226318

Recruiting

West Chester, Ohio, United States, 45069

Sooner Clinical Research /ID# 226384

Recruiting

Oklahoma City, Oklahoma, United States, 73116

Beaumont Psychiatric Clinic /ID# 267484

Recruiting

Beaumont, Texas, United States, 77706

Houston Clinical Trials - Bellaire /ID# 274189

Recruiting

Bellaire, Texas, United States, 77401

Texas Research Group /ID# 270050

Recruiting

Coppell, Texas, United States, 75019

Relaro Medical Trials /ID# 227156

Recruiting

Dallas, Texas, United States, 75243

Earle Research /ID# 253782

Recruiting

Friendswood, Texas, United States, 77546

Kaleidoscope Clinical Research /ID# 277650

Recruiting

Houston, Texas, United States, 77089

Contacts

Site Coordinator

832-969-6157sekeia.willis@sclamanagement.com

Livingspring Family Medical Center /ID# 262706

Recruiting

Mansfield, Texas, United States, 76063-5622

Aim Trials /ID# 226367

Recruiting

Plano, Texas, United States, 75093

Contacts

Site Coordinator

214-856-2778

Perceptive Pharma Research /ID# 262219

Recruiting

Richmond, Texas, United States, 77407

Family Psychiatry of The Woodlands /ID# 226290

Recruiting

The Woodlands, Texas, United States, 77381

Pantheon Clinical Research /ID# 270879

Recruiting

Bountiful, Utah, United States, 84010

Core Clinical Research /ID# 226374

Recruiting

Everett, Washington, United States, 98201

More Information

Sponsor

AbbVie

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

  • Depression
  • RGH-188
  • Bipolar I Disorder
  • Vraylar
  • Cariprazine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by AbbVie on 2026-07-27.