Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

310

Participants

Timeline

Start Date

February 1, 2021

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2025

Conditions
SchizophreniaBipolar I DisorderAutism Spectrum Disorder (ASD)
Interventions
DRUG

Cariprazine Flexible Dose

1 capsule to be taken orally at approximately the same time of day (morning or evening)

DRUG

Cariprazine Flexible Dose

Dose solution (in milliliters) to be taken orally at approximately the same time of day (morning or evening)

Trial Locations (42)

14215

Erie County Medical Center /ID# 237204, Buffalo

30030

CenExcel iResearch LLC /ID# 237391, Decatur

30331

Atlanta Center for Medical Research /ID# 234698, Atlanta

30338

Atlanta Behavioral Research, LLC /ID# 236374, Dunwoody

32607

Sarkis Clinical Trials /ID# 236893, Gainesville

32746

Sandhill Research LLC /ID# 251239, Lake Mary

32751

K2 Medical Research - Orlando - South Orlando Avenue /ID# 257528, Orlando

32803

APG Research, LLC /ID# 251153, Orlando

33016

Galiz Research- Palmetto Medical Plaza /ID# 236277, Hialeah

33122

D&H Doral Research Center-Doral /ID# 255459, Doral

33125

Columbus Clinical Services, Llc /Id# 234281, Miami

33174

Florida Research Center, Inc. /ID# 236515, Miami

36303

Harmonex Neuroscience Research /ID# 234938, Dothan

44012

Quest Therapeutics of Avon Lake /ID# 235956, Avon Lake

45069

CincyScience /ID# 236390, West Chester

45219

University of Cincinnati /ID# 236913, Cincinnati

45229

Cincinnati Children's Hospital /ID# 251020, Cincinnati

60169

Ascension Illinois /ID# 235857, Hoffman Estates

72712

Pillar Clinical Research /ID# 236434, Bentonville

75093

AIM Trials /ID# 236368, Plano

77381

Family Psychiatry of The Woodlands /ID# 236426, The Woodlands

78759

BioBehavioral Research of Austin /ID# 236479, Austin

90807

Duplicate_Alliance for Research - Long Beach /ID# 236261, Long Beach

91730

Prospective Research Innovations Inc /ID# 236098, Rancho Cucamonga

91786

Pacific Clinical Research Management Group /ID# 234377, Upland

92805

Advanced Research Center /ID# 241903, Anaheim

92868

ATP Clinical Research- Orange /ID# 257095, Orange

98201

Core Clinical Research /ID# 236409, Everett

92868-4203

CHOC Children's Hospital /ID# 251019, Orange

92103-8229

University of California, San Diego Department of Psychiatry /ID# 236466, San Diego

33030-4613

Advanced Research Institute of Miami /ID# 242505, Homestead

33126-2018

G+C Research Group, LLC /ID# 261398, Miami

33176-3227

Links Clinical Trials /ID# 240975, Miami

33166-7225

South Florida Research Ph I-IV /ID# 237453, Miami Springs

33321-2979

D&H Tamarac Research Center /ID# 250435, Tamarac

07111

Med Clinical Research Partners LLC /ID# 236071, Irvington

28501-1603

New Dawn Psychiatric Services PLLC /ID# 236597, Kinston

73116-1423

Cutting Edge Research Group /ID# 236664, Oklahoma City

75251-2202

Cedar Health Research /ID# 259364, Dallas

77090-2641

Red Oak Psychiatry Associates /ID# 236602, Houston

00727

Dr. Samuel Sanchez PSC /ID# 246047, Caguas

00917-3104

GCM Medical Group PSC /ID# 246048, San Juan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AbbVie

INDUSTRY