Skip to main content

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.

Recruiting · Phase 3 · NCT04777357

Conditions: Depression, Bipolar I Disorder

At a glance

Research payments reported, 2025
$784,151
U.S. investigators named
58
Sites paid
71
Planned or actual enrollment
380

About the trial

Sponsor
AbbVie
Tested
Cariprazine (drug), Placebo (drug)
Dates
Started 2021-04-28; completion 2027-03
Results posted
Not yet

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 …

From ClinicalTrials.gov, last updated 2026-07-27. Full record, eligibility and contacts (opens in a new tab)

Industry funding

AbbVie Inc. reported $784,151 in research payments for this study in 2025 (166 payments).

Products named: Vraylar

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

  • Advanced Research Center Inc $99,787
  • Eastside Therapeutic Resource Inc $74,765
  • Advanced Research Institute Of $70,164
  • Florida Research Center Inc $63,661
  • National Institute of Clinical $56,684
  • D&h Doral Research Center-Doral $46,410
  • Cenexel Iresearch LLC $37,395
  • The Clinical Trials Network LLC $33,500
  • Pantheon Clinical Research LLC $27,717
  • D&h Tamarac Research Center LLC $23,890
  • Advanced Quality Medical Research $23,814
  • Texas Research Group PLLC $23,622
  • Perceptive Pharma Research LLC $23,569
  • Cincyscience $20,659
  • Sooner Clinical Research Inc $17,410
  • Nova Psychiatry Inc $16,506
  • Qcare Site Services Inc $15,225
  • Aim Trials LLC $11,657
  • University of South Florida $9,201
  • Advanced Research Institute of Miami LLC $8,460
  • Hugo W Moser Research Institute at $5,695
  • Lumos Clinical Research Center LLC $5,500
  • Panhandle Research $5,500
  • Prime Clinical Research Inc $5,320
  • Alexian Brothers Health System $4,933
  • Children's Hospital of Orange County, CA $4,610
  • Biobehavioral Research of Austin $3,325
  • Prospective Research $2,200
  • Relaro Medical Trials $2,099
  • Haidar Almhana Nieding LLC $2,000
  • Dr Samuel Sanchez Psc $1,900
  • Pantheon Clinical Research $1,506
  • Apg Research LLC $1,425
  • Inland Psychiatric Medical Group Inc $1,270
  • Bay Area Psychiatry Group $1,100
  • Panhandle Research and Medical Clinic LLC $1,100
  • San Juan Med $1,100
  • Family Psychiatry of the Woodlands $1,100
  • Great Lakes Medical Research LLC $1,100
  • Clinnova Research Solutions $1,100
  • Gc Research Group $1,100
  • Hugo W Moser Research Institute $1,100
  • Indiana University Health Center $1,100
  • Atlanta Behavioral Research LLC $1,100
  • Eastside Therapeutic Resources $1,100
  • Med Clinical Research PArtners LLC $1,100
  • Aim Trials $1,100
  • Family Psychiatry Services $1,100
  • Advanced Research Center $1,100
  • D&h Doral Research Centerdoral $1,100
  • Dh Tamarac Research Center LLC $1,100
  • Cenexel Iresearch Atlanta $1,100
  • Advanced Research Institute of Miami $1,100
  • South Florida Research Ph I-Iv $1,000
  • Pacific Clinical Research $1,000
  • North American Research Institutesan Dimas $916
  • Sp Research PLLC $916
  • Columbus Clinical Services LLC $916
  • University of California Davis Medical Center, CA $864
  • Pacific Clinical Research Medical Group $825
  • University of South Florida Board of Trustees $733
  • Scla Management LLC $681
  • Gcm Medical Group Psc $650
  • The Research Foundation for The State University of New York $641
  • Gemini Testing Enterprises Inc $641
  • Denali Health Atlanta LLC $498
  • Houston Clinical Trials LLC $498
  • Atlanta Center for Medical Research $458
  • Paradigm Research Professionals LLC $275
  • Red Oak Psychiatry Associates $183
  • University of Cincinnati $183

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.