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.
Start Date
4/28/2021
Completion Date
3/1/2027
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.
Eligibility Criteria
Age Range: 10 years to 17 years
Interventions
Cariprazine
Placebo
Conditions
Locations
Pillar Clinical Research /ID# 226504
Bentonville, Arkansas 72712
United States
Advanced Research Center /ID# 227073
Anaheim, California 92805
United States
Care Access Research /ID# 226316
Beverly Hills, California 90212
United States
Inland Pyschiatric Medical Group - Chino /ID# 278667
Chino, California 91710
United States
ProScience Research Group /ID# 226223
Culver City, California 90230-6632
United States
National Institute of Clinical Research - Garden Grove /ID# 262835
Garden Grove, California 92844
United States
Accellacare - Long Beach /ID# 279482
Long Beach, California 90807
United States
Duplicate_Alliance for Research - Long Beach /ID# 226522
Long Beach, California 90807
United States
CHOC Children's Hospital /ID# 260298
Orange, California 92868-4203
United States
ATP Clinical Research- Orange /ID# 253719
Orange, California 92868
United States
Prospective Research Innovations Inc /ID# 240774
Rancho Cucamonga, California 91730
United States
Inland Psychiatric Medical Group /ID# 274621
Redlands, California 92373
United States
University of California Davis Health /ID# 268306
Sacramento, California 95817
United States
University of California, San Diego Department of Psychiatry /ID# 226463
San Diego, California 92103-8229
United States
Lumos Clinical Research Center /ID# 262805
San Jose, California 95124-4108
United States
Pacific Clinical Research Management Group /ID# 227075
Upland, California 91786
United States
Next Level Clinical Trials /ID# 277152
West Covina, California 91790
United States
D&H Doral Research Center-Doral /ID# 255458
Doral, Florida 33122
United States
Advanced Research Institute of Miami /ID# 228222
Homestead, Florida 33030-4613
United States
Columbus Clinical Services, Llc /Id# 229792
Miami, Florida 33125
United States
G+C Research Group, LLC /ID# 261399
Miami, Florida 33126-2018
United States
Florida Research Center, Inc. /ID# 240775
Miami, Florida 33174
United States
South Florida Research Ph I-IV /ID# 240778
Miami Springs, Florida 33166-7225
United States
Medical Research Group of Central Florida /ID# 256757
Orange City, Florida 32763
United States
APG Research, LLC /ID# 226519
Orlando, Florida 32803
United States
Nova Psychiatry Inc. /ID# 270892
Orlando, Florida 32803
United States
Panhandle Research and Medical Clinic, LLC /ID# 268522
Pensacola, Florida 32502
United States
D&H Tamarac Research Center /ID# 250434
Tamarac, Florida 33321-2979
United States
University of South Florida- Neuroscience Institute /ID# 246508
Tampa, Florida 33613
United States
Atlanta Center for Medical Research /ID# 226480
Atlanta, Georgia 30331
United States
CenExcel iResearch LLC /ID# 228695
Decatur, Georgia 30030
United States
Atlanta Behavioral Research, LLC /ID# 226486
Dunwoody, Georgia 30338
United States
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 226371
Stockbridge, Georgia 30281
United States
Denali Health Atlanta, LLC /ID# 278167
Stone Mountain, Georgia 30083
United States
Duplicate_Ascension St. Elizabeth /ID# 240772
Chicago, Illinois 60622
United States
Baber Research Group /ID# 232279
Naperville, Illinois 60563-6502
United States
Advanced Quality Medical Research /ID# 272902
Orland Park, Illinois 60462
United States
Indiana University /ID# 260705
Indianapolis, Indiana 46202-3082
United States
Benchmark Research /ID# 260714
Shreveport, Louisiana 71101
United States
The Kennedy Krieger Institute /ID# 226509
Baltimore, Maryland 21205
United States
Med Clinical Research Partners LLC /ID# 240773
Irvington, New Jersey 07111
United States
Duplicate_NeuroCognitive and Behavioral Institute, Inc /ID# 227077
Mount Arlington, New Jersey 07856-1315
United States
UB Department of Psychiatry /ID# 226373
Buffalo, New York 14215
United States
New Dawn Psychiatric Services PLLC /ID# 229782
Kinston, North Carolina 28501-1603
United States
Quest Therapeutics of Avon Lake /ID# 226349
Avon Lake, Ohio 44012
United States
University of Cincinnati /ID# 226465
Cincinnati, Ohio 45219
United States
Cleveland Clinic - Cleveland /ID# 276309
Cleveland, Ohio 44195
United States
CincyScience /ID# 226318
West Chester, Ohio 45069
United States
IPS Research Company /ID# 227072
Oklahoma City, Oklahoma 73106
United States
SP Research, PLLC /ID# 259428
Oklahoma City, Oklahoma 73112-8729
United States
Cutting Edge Research Group /ID# 240777
Oklahoma City, Oklahoma 73116-1423
United States
Paradigm Research Professionals /ID# 260719
Oklahoma City, Oklahoma 73116
United States
Sooner Clinical Research /ID# 226384
Oklahoma City, Oklahoma 73116
United States
BioBehavioral Research of Austin /ID# 227076
Austin, Texas 78759
United States
Beaumont Psychiatric Clinic /ID# 267484
Beaumont, Texas 77706
United States
Houston Clinical Trials - Bellaire /ID# 274189
Bellaire, Texas 77401
United States
Texas Research Group /ID# 270050
Coppell, Texas 75019
United States
Relaro Medical Trials /ID# 227156
Dallas, Texas 75243
United States
Earle Research /ID# 253782
Friendswood, Texas 77546
United States
McGovern Medical School /ID# 240779
Houston, Texas 77054
United States
Southwest Biomed Research Center LLC /ID# 226340
Houston, Texas 77063
United States
Kaleidoscope Clinical Research /ID# 277650
Houston, Texas 77089
United States
Red Oak Psychiatry Associates /ID# 240776
Houston, Texas 77090-2641
United States
Livingspring Family Medical Center /ID# 262706
Mansfield, Texas 76063-5622
United States
Aim Trials /ID# 226367
Plano, Texas 75093
United States
Perceptive Pharma Research /ID# 262219
Richmond, Texas 77407
United States
Family Psychiatry of The Woodlands /ID# 226290
The Woodlands, Texas 77381
United States
Pantheon Clinical Research /ID# 270879
Bountiful, Utah 84010
United States
Core Clinical Research /ID# 226374
Everett, Washington 98201
United States
Dr. Samuel Sanchez PSC /ID# 245952
Caguas, 00727
Puerto Rico
GCM Medical Group /ID# 245951
San Juan, 00917-3104
Puerto Rico
Clinica of Glazunova /ID# 229416
Krasnodar, Krasnodarskiy Kray 350051
Russia
Duplicate_Scientific Centre of Personalized Medicine /ID# 226380
Moscow, Moscow 105082
Russia
Duplicate_Central Clinical Psychiatric Hospital /ID# 226381
Moscow, Moscow 127083
Russia
Orenburg Regional Clinical Psychiatric Hospital #1 /ID# 226462
Orenburg, Orenburg Oblast 460006
Russia
Psychotherapeutics Center Podderzhka /ID# 226348
Stavropol, Stavropol Kray 355029
Russia
Clinical Psychiatry Hospital #1 of Nizhniy Novgorod /ID# 226226
Nizhny Novgorod, 603155
Russia
Psychiatric hospital #1 /ID# 226516
Saint Petersburg, 190121
Russia
National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 226515
Saint Petersburg, 192019
Russia
Medgard Clinic /ID# 228598
Saratov, 410028
Russia
Saratov City Clinical Hospital #2 n.a. V. I. Razumovsky /ID# 226222
Saratov, 410028
Russia