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 · NCT04777357
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 10–17 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 380
- US sites recruiting
- 31
- Study start
- April 28, 2021
- Record last updated
- July 27, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Cariprazine; Placebo
Conditions: Depression; Bipolar I Disorder
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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).
Recruiting US locations
Advanced Research Center /ID# 227073
Anaheim, CA 92805
Inland Pyschiatric Medical Group - Chino /ID# 278667
Chino, CA 91710
Accellacare - Long Beach /ID# 279482
Long Beach, CA 90807
CHOC Children's Hospital /ID# 260298
Orange, CA 92868-4203
Inland Psychiatric Medical Group /ID# 274621
Redlands, CA 92373
University of California Davis Health /ID# 268306
Sacramento, CA 95817
Site contact: Site Coordinator · 916-734-3574 · cqthai@health.ucdavis.edu
Next Level Clinical Trials /ID# 277152
West Covina, CA 91790
Site contact: Site Coordinator · 773-424-2430 · jemmanuella@nextleveltrials.com
D&H Doral Research Center-Doral /ID# 255458
Doral, FL 33122
Florida Research Center, Inc. /ID# 240775
Miami, FL 33174
Medical Research Group of Central Florida /ID# 256757
Orange City, FL 32763
Nova Psychiatry Inc. /ID# 270892
Orlando, FL 32803
D&H Tamarac Research Center /ID# 250434
Tamarac, FL 33321-2979
CenExcel iResearch LLC /ID# 228695
Decatur, GA 30030
Denali Health Atlanta, LLC /ID# 278167
Stone Mountain, GA 30083
Advanced Quality Medical Research /ID# 272902
Orland Park, IL 60462
Med Clinical Research Partners LLC /ID# 240773
Irvington, NJ 07111
Cleveland Clinic - Cleveland /ID# 276309
Cleveland, OH 44195
CincyScience /ID# 226318
West Chester, OH 45069
Sooner Clinical Research /ID# 226384
Oklahoma City, OK 73116
Beaumont Psychiatric Clinic /ID# 267484
Beaumont, TX 77706
Houston Clinical Trials - Bellaire /ID# 274189
Bellaire, TX 77401
Texas Research Group /ID# 270050
Coppell, TX 75019
Relaro Medical Trials /ID# 227156
Dallas, TX 75243
Earle Research /ID# 253782
Friendswood, TX 77546
Kaleidoscope Clinical Research /ID# 277650
Houston, TX 77089
Site contact: Site Coordinator · 832-969-6157 · sekeia.willis@sclamanagement.com
Livingspring Family Medical Center /ID# 262706
Mansfield, TX 76063-5622
Aim Trials /ID# 226367
Plano, TX 75093
Site contact: Site Coordinator · 214-856-2778
Perceptive Pharma Research /ID# 262219
Richmond, TX 77407
Family Psychiatry of The Woodlands /ID# 226290
The Woodlands, TX 77381
Pantheon Clinical Research /ID# 270879
Bountiful, UT 84010
Core Clinical Research /ID# 226374
Everett, WA 98201
Study contacts (from the official record)
- ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com
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