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.

ClinicalTrials.gov ID: NCT04777357

Public ClinicalTrials.gov record NCT04777357. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 9, 2026, 3:42 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT04777357
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: AbbVie; Industry
Enrollment: 380 participants

Conditions and interventions

Conditions

Interventions

Cariprazine Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 10 Years to 17 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 27, 2021
Primary completion: Feb 28, 2027
Completion: Feb 28, 2027
Last update posted: Jul 26, 2026

2021 – 2027

United States locations

U.S. sites: 69
U.S. states: 16
U.S. cities: 57

Facility	City	State	ZIP	Site status
Pillar Clinical Research /ID# 226504	Bentonville	Arkansas	72712	Completed
Advanced Research Center /ID# 227073	Anaheim	California	92805	Recruiting
Care Access Research /ID# 226316	Beverly Hills	California	90212	Completed
Inland Pyschiatric Medical Group - Chino /ID# 278667	Chino	California	91710	Recruiting
ProScience Research Group /ID# 226223	Culver City	California	90230-6632	Completed
National Institute of Clinical Research - Garden Grove /ID# 262835	Garden Grove	California	92844	Completed
Accellacare - Long Beach /ID# 279482	Long Beach	California	90807	Recruiting
Duplicate_Alliance for Research - Long Beach /ID# 226522	Long Beach	California	90807	Completed
CHOC Children's Hospital /ID# 260298	Orange	California	92868-4203	Recruiting
ATP Clinical Research- Orange /ID# 253719	Orange	California	92868	Completed
Prospective Research Innovations Inc /ID# 240774	Rancho Cucamonga	California	91730	Completed
Inland Psychiatric Medical Group /ID# 274621	Redlands	California	92373	Recruiting
University of California Davis Health /ID# 268306	Sacramento	California	95817	Recruiting
University of California, San Diego Department of Psychiatry /ID# 226463	San Diego	California	92103-8229	Completed
Lumos Clinical Research Center /ID# 262805	San Jose	California	95124-4108	Completed
Pacific Clinical Research Management Group /ID# 227075	Upland	California	91786	Completed
Next Level Clinical Trials /ID# 277152	West Covina	California	91790	Recruiting
D&H Doral Research Center-Doral /ID# 255458	Doral	Florida	33122	Recruiting
Advanced Research Institute of Miami /ID# 228222	Homestead	Florida	33030-4613	Completed
Columbus Clinical Services, Llc /Id# 229792	Miami	Florida	33125	Completed
G+C Research Group, LLC /ID# 261399	Miami	Florida	33126-2018	Completed
Florida Research Center, Inc. /ID# 240775	Miami	Florida	33174	Recruiting
South Florida Research Ph I-IV /ID# 240778	Miami Springs	Florida	33166-7225	Completed
Medical Research Group of Central Florida /ID# 256757	Orange City	Florida	32763	Recruiting
APG Research, LLC /ID# 226519	Orlando	Florida	32803	Completed
Nova Psychiatry Inc. /ID# 270892	Orlando	Florida	32803	Recruiting
Panhandle Research and Medical Clinic, LLC /ID# 268522	Pensacola	Florida	32502	Completed
D&H Tamarac Research Center /ID# 250434	Tamarac	Florida	33321-2979	Recruiting
University of South Florida- Neuroscience Institute /ID# 246508	Tampa	Florida	33613	Completed
Atlanta Center for Medical Research /ID# 226480	Atlanta	Georgia	30331	Completed
CenExcel iResearch LLC /ID# 228695	Decatur	Georgia	30030	Recruiting
Atlanta Behavioral Research, LLC /ID# 226486	Dunwoody	Georgia	30338	Completed
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 226371	Stockbridge	Georgia	30281	Completed
Denali Health Atlanta, LLC /ID# 278167	Stone Mountain	Georgia	30083	Recruiting
Duplicate_Ascension St. Elizabeth /ID# 240772	Chicago	Illinois	60622	Completed
Baber Research Group /ID# 232279	Naperville	Illinois	60563-6502	Completed
Advanced Quality Medical Research /ID# 272902	Orland Park	Illinois	60462	Recruiting
Indiana University /ID# 260705	Indianapolis	Indiana	46202-3082	Completed
Benchmark Research /ID# 260714	Shreveport	Louisiana	71101	Completed
The Kennedy Krieger Institute /ID# 226509	Baltimore	Maryland	21205	Completed
Med Clinical Research Partners LLC /ID# 240773	Irvington	New Jersey	07111	Recruiting
Duplicate_NeuroCognitive and Behavioral Institute, Inc /ID# 227077	Mount Arlington	New Jersey	07856-1315	Completed
UB Department of Psychiatry /ID# 226373	Buffalo	New York	14215	Completed
New Dawn Psychiatric Services PLLC /ID# 229782	Kinston	North Carolina	28501-1603	Completed
Quest Therapeutics of Avon Lake /ID# 226349	Avon Lake	Ohio	44012	Completed
University of Cincinnati /ID# 226465	Cincinnati	Ohio	45219	Completed
Cleveland Clinic - Cleveland /ID# 276309	Cleveland	Ohio	44195	Recruiting
CincyScience /ID# 226318	West Chester	Ohio	45069	Recruiting
IPS Research Company /ID# 227072	Oklahoma City	Oklahoma	73106	Completed
SP Research, PLLC /ID# 259428	Oklahoma City	Oklahoma	73112-8729	Completed
Cutting Edge Research Group /ID# 240777	Oklahoma City	Oklahoma	73116-1423	Completed
Paradigm Research Professionals /ID# 260719	Oklahoma City	Oklahoma	73116	Completed
Sooner Clinical Research /ID# 226384	Oklahoma City	Oklahoma	73116	Recruiting
BioBehavioral Research of Austin /ID# 227076	Austin	Texas	78759	Completed
Beaumont Psychiatric Clinic /ID# 267484	Beaumont	Texas	77706	Recruiting
Houston Clinical Trials - Bellaire /ID# 274189	Bellaire	Texas	77401	Recruiting
Texas Research Group /ID# 270050	Coppell	Texas	75019	Recruiting
Relaro Medical Trials /ID# 227156	Dallas	Texas	75243	Recruiting
Earle Research /ID# 253782	Friendswood	Texas	77546	Recruiting
McGovern Medical School /ID# 240779	Houston	Texas	77054	Completed
Southwest Biomed Research Center LLC /ID# 226340	Houston	Texas	77063	Completed
Kaleidoscope Clinical Research /ID# 277650	Houston	Texas	77089	Recruiting
Red Oak Psychiatry Associates /ID# 240776	Houston	Texas	77090-2641	Completed
Livingspring Family Medical Center /ID# 262706	Mansfield	Texas	76063-5622	Recruiting
Aim Trials /ID# 226367	Plano	Texas	75093	Recruiting
Perceptive Pharma Research /ID# 262219	Richmond	Texas	77407	Recruiting
Family Psychiatry of The Woodlands /ID# 226290	The Woodlands	Texas	77381	Recruiting
Pantheon Clinical Research /ID# 270879	Bountiful	Utah	84010	Recruiting
Core Clinical Research /ID# 226374	Everett	Washington	98201	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04777357, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 26, 2026 · Synced Sep 9, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04777357 live on ClinicalTrials.gov.

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