Phase
Condition
Depression
Treatment
Cariprazine
Placebo
Clinical Study ID
Ages 10-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants with Diagnostic and Statistical Manual of Mental Disorders, FifthEdition (DSM-5) primary diagnosis of bipolar I disorder as confirmed by KiddieSchedule for Affective Disorders and Schizophrenia for School-Age Children-Presentand 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 andVisit 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) atVisit 1 and Visit 2.
Exclusion
Exclusion Criteria:
Participants with DSM-5 diagnosis of schizophrenia, schizoaffective disorder,schizophreniform disorder, brief psychotic disorder, psychotic disorder due toanother medical condition, PTSD, antisocial personality disorder, or borderlinepersonality disorder.
Participant has a history of meeting DSM-5 diagnosis for any substance-relateddisorder (except caffeine- and tobacco-related) within the 3 months before ScreeningVisit 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, ordocumented 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 thatpredisposes to seizures.
Participant requires concomitant treatment with moderate or strong CYP3A4 inhibitorsor with any CYP3A4 inducers.
Participant requires concomitant treatment with any prohibited medication,supplement, or herbal product, including any psychotropic drug or any drug withpsychotropic activity or with a potentially psychotropic component.
Use of a depot antipsychotic within 2 cycles of their respective dosing intervalprior 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, retinaldetachment, intraocular surgery, laser treatment, glaucoma, cataracts, or clinicallysignificant ocular trauma (with the exception of refractive errors).
Study Design
Connect with a study center
MHAT Targovishte /ID# 226262
Targovishte, 7700
BulgariaSite Not Available
Diagnostic consultative center Mladost M /ID# 226291
Varna, 9020
BulgariaSite Not Available
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 229417
Gdansk, Pomorskie 80-546
PolandSite Not Available
Zachodniopomorski Instytut Psychoterapii /ID# 228218
Szczecin, Zachodniopomorskie 70-486
PolandSite Not Available
Clinical Research Center /ID# 228219
Poznan, 60-848
PolandSite Not Available
Dr. Samuel Sanchez PSC /ID# 245952
Caguas, 00727
Puerto RicoActive - Recruiting
GCM Medical Group PSC /ID# 245951
San Juan, 00917-3104
Puerto RicoActive - Recruiting
Asociatia Comunitatea Oamenilor /ID# 226514
Craiova, Dolj 200157
RomaniaSite Not Available
Clinica de Neuropsihiatrie Infantila Timisoara /Id# 226347
Timisoara, Timis 300329
RomaniaSite Not Available
Institutul de Psihiatrie Socola Iasi /ID# 226200
Iasi, 700282
RomaniaSite Not Available
City Psychiatric Hospital of Akhangelsk /ID# 226325
Arkhangelsk, Amurskaya Oblast 163530
Russian FederationSite Not Available
Clinica of Glazunova /ID# 229416
Krasnodar, Krasnodarskiy Kray 350051
Russian FederationCompleted
Orenburg Regional Clinical Psychiatric Hospital #1 /ID# 226462
Orenburg, Orenburgskaya Oblast 460006
Russian FederationCompleted
Psychotherapeutics Center Podderzhka /ID# 226348
Stavropol, Stavropol Skiy Kray 355029
Russian FederationCompleted
Kazan State Medical University /ID# 239866
Kazan, Tatarstan, Respublika 420012
Russian FederationSite Not Available
Central Clinical Psychiatric Hospital /ID# 226381
Moscow, 127083
Russian FederationCompleted
Scientific Centre of Personalized Medicine /ID# 226380
Moscow, 105082
Russian FederationCompleted
Clinical Psychiatry Hospital #1 of Nizhniy Novgorod /ID# 226226
Nizhny Novgorod, 603155
Russian FederationCompleted
I. I. Skvortsov-Stepanov Psychiatric Hospital #3 /ID# 226325
Saint Petersburg, 197341
Russian FederationSite Not Available
Psychiatric hospital #1 /ID# 226516
Saint-Petersburg, 190121
Russian FederationSite Not Available
Medgard Clinic /ID# 228598
Saratov, 410028
Russian FederationCompleted
Saratov City Clinical Hospital #2 n.a. V. I. Razumovsky /ID# 226222
Saratov, 410028
Russian FederationCompleted
National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 226515
St. Petersburg, 192019
Russian FederationCompleted
Psychiatric hospital #1 /ID# 226516
St. Petersburg, 190121
Russian FederationCompleted
University Clinical Center Kragujevac /ID# 229138
Kragujevac, Sumadijski Okrug 34000
SerbiaSite Not Available
Clinical Center Vojvodina /ID# 226521
Novi Sad, Vojvodina 21000
SerbiaSite Not Available
Clinic of Neurology and Psychiatry for Children and Youth /ID# 226513
Belgrade, 11000
SerbiaSite Not Available
Center for mental health protection, Clinical Centre Nis /ID# 229137
Nis, 18000
SerbiaSite Not Available
SIC Institute of Health Care for Children and Adolescents of the NAMS of Ukraine /ID# 226506
Kharkiv, 61153
UkraineSite Not Available
CNE of LOR Lviv Regional Clinical Psychiatric Hospital /ID# 226461
Lviv, 79021
UkraineSite Not Available
MNCE Odesa Regional Medical Center for Mental Health /ID# 226231
Odesa, 65006
UkraineSite Not Available
The University of Alabama at Birmingham /ID# 227074
Birmingham, Alabama 35233-1718
United StatesSite Not Available
Pillar Clinical Research /ID# 226504
Bentonville, Arkansas 72712
United StatesCompleted
Advanced Research Center /ID# 227073
Anaheim, California 92805
United StatesActive - Recruiting
Care Access Research /ID# 226316
Beverly Hills, California 90212
United StatesCompleted
ProScience Research Group /ID# 226223
Culver City, California 90230-6632
United StatesCompleted
National Institute of Clinical Research - Garden Grove /ID# 262835
Garden Grove, California 92844
United StatesActive - Recruiting
Alliance for Research - Long Beach /ID# 226522
Long Beach, California 90807
United StatesCompleted
Duplicate_Alliance for Research - Long Beach /ID# 226522
Long Beach, California 90807
United StatesCompleted
ATP Clinical Research- Orange /ID# 253719
Orange, California 92868
United StatesActive - Recruiting
CHOC Children's Hospital /ID# 260298
Orange, California 92868-4203
United StatesActive - Recruiting
Prospective Research Innovations Inc /ID# 240774
Rancho Cucamonga, California 91730
United StatesCompleted
University of California, San Diego Department of Psychiatry /ID# 226463
San Diego, California 92103-8229
United StatesCompleted
Lumos Clinical Research Center /ID# 262805
San Jose, California 95124-4108
United StatesActive - Recruiting
Pacific Clinical Research Management Group /ID# 227075
Upland, California 91786
United StatesActive - Recruiting
D&H Doral Research Center-Doral /ID# 255458
Doral, Florida 33122
United StatesActive - Recruiting
Galiz Research - Palmetto Medical Plaza /ID# 226518
Hialeah, Florida 33016
United StatesSite Not Available
Advanced Research Institute of Miami /ID# 228222
Homestead, Florida 33030-4613
United StatesActive - Recruiting
Columbus Clinical Services, Llc /Id# 229792
Miami, Florida 33125-5114
United StatesActive - Recruiting
Florida Research Center, Inc. /ID# 240775
Miami, Florida 33174
United StatesActive - Recruiting
G+C Research Group, LLC /ID# 261399
Miami, Florida 33126-2018
United StatesActive - Recruiting
South Florida Research Ph I-IV /ID# 240778
Miami Springs, Florida 33166-7225
United StatesCompleted
Medical Research Group of Central Florida /ID# 256757
Orange City, Florida 32763
United StatesActive - Recruiting
APG Research, LLC /ID# 226519
Orlando, Florida 32803
United StatesActive - Recruiting
Panhandle Research and Medical Clinic, LLC /ID# 268522
Pensacola, Florida 32502
United StatesActive - Recruiting
D&H Tamarac Research Center /ID# 250434
Tamarac, Florida 33321-2979
United StatesActive - Recruiting
University of South Florida /ID# 246508
Tampa, Florida 33612-2201
United StatesActive - Recruiting
University of South Florida- Neuroscience Institute /ID# 246508
Tampa, Florida 33613
United StatesActive - Recruiting
Atlanta Center for Medical Research /ID# 226480
Atlanta, Georgia 30331
United StatesActive - Recruiting
CenExcel iResearch LLC /ID# 228695
Decatur, Georgia 30030
United StatesActive - Recruiting
Atlanta Behavioral Research, LLC /ID# 226486
Dunwoody, Georgia 30338
United StatesActive - Recruiting
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 226371
Stockbridge, Georgia 30281
United StatesCompleted
Ascension St. Elizabeth /ID# 240772
Chicago, Illinois 60622
United StatesCompleted
Baber Research Group /ID# 232279
Naperville, Illinois 60563-6502
United StatesCompleted
Indiana University /ID# 260705
Indianapolis, Indiana 46202-3082
United StatesActive - Recruiting
Benchmark Research /ID# 260714
Shreveport, Louisiana 71101-4603
United StatesActive - Recruiting
The Kennedy Krieger Institute /ID# 226509
Baltimore, Maryland 21205
United StatesActive - Recruiting
Med Clinical Research Partners LLC /ID# 240773
Irvington, New Jersey 07111
United StatesActive - Recruiting
NeuroCognitive and Behavioral Institute, Inc /ID# 227077
Mount Arlington, New Jersey 07856-1315
United StatesCompleted
Jersey Shore University Medical Center /ID# 226327
Neptune, New Jersey 07753
United StatesSite Not Available
UB Department of Psychiatry /ID# 226373
Buffalo, New York 14215
United StatesActive - Recruiting
Finger Lakes Clinical Research /ID# 228548
Rochester, New York 14618-1609
United StatesSite Not Available
New Dawn Psychiatric Services PLLC /ID# 229782
Kinston, North Carolina 28501-1603
United StatesActive - Recruiting
Wake Forest Baptist Medical Center /ID# 231643
Winston-Salem, North Carolina 27157-0001
United StatesSite Not Available
Quest Therapeutics of Avon Lake /ID# 226349
Avon Lake, Ohio 44012
United StatesCompleted
University of Cincinnati /ID# 226465
Cincinnati, Ohio 45219
United StatesCompleted
CincyScience /ID# 226318
West Chester, Ohio 45069
United StatesActive - Recruiting
Cutting Edge Research Group /ID# 240777
Oklahoma City, Oklahoma 73116-1423
United StatesCompleted
IPS Research Company /ID# 227072
Oklahoma City, Oklahoma 73106
United StatesCompleted
Paradigm Research Professionals /ID# 260719
Oklahoma City, Oklahoma 73116
United StatesCompleted
SP Research, PLLC /ID# 259428
Oklahoma City, Oklahoma 73112-8729
United StatesActive - Recruiting
Sooner Clinical Research /ID# 226384
Oklahoma City, Oklahoma 73116
United StatesActive - Recruiting
BioBehavioral Research of Austin /ID# 227076
Austin, Texas 78759
United StatesCompleted
Beaumont Psychiatric Clinic /ID# 267484
Beaumont, Texas 77706
United StatesActive - Recruiting
Independent Research Center /ID# 270050
Coppell, Texas 75019
United StatesActive - Recruiting
Relaro Medical Trials /ID# 227156
Dallas, Texas 75243
United StatesActive - Recruiting
Earle Research /ID# 253782
Friendswood, Texas 77546
United StatesActive - Recruiting
McGovern Medical School /ID# 240779
Houston, Texas 77054
United StatesCompleted
Red Oak Psychiatry Associates /ID# 240776
Houston, Texas 77090-2641
United StatesCompleted
Southwest Biomed Research Center LLC /ID# 226340
Houston, Texas 77063
United StatesCompleted
Livingspring Family Medical Center /ID# 262706
Mansfield, Texas 76063-5622
United StatesActive - Recruiting
AIM Trials /ID# 226367
Plano, Texas 75093
United StatesActive - Recruiting
Perceptive Pharma Research /ID# 262219
Richmond, Texas 77407
United StatesActive - Recruiting
Family Psychiatry of The Woodlands /ID# 226290
The Woodlands, Texas 77381
United StatesActive - Recruiting
Pantheon Clinical Research /ID# 270879
Bountiful, Utah 84010
United StatesActive - Recruiting
Core Clinical Research /ID# 226374
Everett, Washington 98201
United StatesActive - Recruiting
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