Actively Recruiting
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.
Led by AbbVie · Updated on 2026-05-12
380
Participants Needed
81
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 10 to 17 years with bipolar I disorder diagnosis confirmed by K-SADS-PL
- Current depressive episode lasting more than 2 weeks and less than 12 months
- Lifetime history of at least one manic episode
- Children's Depression Rating Scale - Revised (CDRS-R) score of 45 or higher at Visits 1 and 2
- Young-Mania Rating Scale (YMRS) score of 12 or lower with YMRS Item 1 score of 2 or lower at Visits 1 and 2
- Clinical Global Impression-Severity (CGI-S) scale score of 4 or higher (moderately ill) at Visits 1 and 2
You will not qualify if you...
- Diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder due to another medical condition, PTSD, antisocial personality disorder, or borderline personality disorder
- Substance-related disorder (except caffeine and tobacco) within 3 months before screening
- History of serotonin syndrome or neuroleptic malignant syndrome
- Four or more mood disturbance episodes within 12 months before Visit 1
- Diagnosis of intellectual disability (IQ below 70), autism spectrum disorders, or chromosomal disorder with developmental impairment
- History of seizures (except febrile seizures)
- Significant head trauma, CNS tumor, or conditions predisposing to seizures
- Need for treatment with moderate or strong CYP3A4 inhibitors or inducers
- Use of prohibited medications or psychotropic drugs prior to screening
- Use of depot antipsychotics within two dosing cycles before screening
- Clozapine treatment at doses of 50 mg/day or higher in past 2 years
- History or current ocular diseases including retinal detachment, intraocular surgery, laser treatment, glaucoma, cataracts, or significant ocular trauma (except refractive errors)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 81 locations
1
Pillar Clinical Research /ID# 226504
Bentonville, Arkansas, United States, 72712
Completed
2
Advanced Research Center /ID# 227073
Anaheim, California, United States, 92805
Actively Recruiting
3
Care Access Research /ID# 226316
Beverly Hills, California, United States, 90212
Completed
4
Inland Pyschiatric Medical Group - Chino /ID# 278667
Chino, California, United States, 91710
Actively Recruiting
5
ProScience Research Group /ID# 226223
Culver City, California, United States, 90230-6632
Completed
6
National Institute of Clinical Research - Garden Grove /ID# 262835
Garden Grove, California, United States, 92844
Completed
7
Accellacare - Long Beach /ID# 279482
Long Beach, California, United States, 90807
Actively Recruiting
8
Duplicate_Alliance for Research - Long Beach /ID# 226522
Long Beach, California, United States, 90807
Completed
9
CHOC Children's Hospital /ID# 260298
Orange, California, United States, 92868-4203
Actively Recruiting
10
ATP Clinical Research- Orange /ID# 253719
Orange, California, United States, 92868
Actively Recruiting
11
Prospective Research Innovations Inc /ID# 240774
Rancho Cucamonga, California, United States, 91730
Completed
12
Inland Psychiatric Medical Group /ID# 274621
Redlands, California, United States, 92373
Actively Recruiting
13
University of California Davis Health /ID# 268306
Sacramento, California, United States, 95817
Actively Recruiting
14
University of California, San Diego Department of Psychiatry /ID# 226463
San Diego, California, United States, 92103-8229
Completed
15
Lumos Clinical Research Center /ID# 262805
San Jose, California, United States, 95124-4108
Actively Recruiting
16
Pacific Clinical Research Management Group /ID# 227075
Upland, California, United States, 91786
Completed
17
Next Level Clinical Trials /ID# 277152
West Covina, California, United States, 91790
Actively Recruiting
18
D&H Doral Research Center-Doral /ID# 255458
Doral, Florida, United States, 33122
Actively Recruiting
19
Advanced Research Institute of Miami /ID# 228222
Homestead, Florida, United States, 33030-4613
Actively Recruiting
20
Columbus Clinical Services, Llc /Id# 229792
Miami, Florida, United States, 33125
Completed
21
G+C Research Group, LLC /ID# 261399
Miami, Florida, United States, 33126-2018
Actively Recruiting
22
Florida Research Center, Inc. /ID# 240775
Miami, Florida, United States, 33174
Actively Recruiting
23
South Florida Research Ph I-IV /ID# 240778
Miami Springs, Florida, United States, 33166-7225
Completed
24
Medical Research Group of Central Florida /ID# 256757
Orange City, Florida, United States, 32763
Actively Recruiting
25
APG Research, LLC /ID# 226519
Orlando, Florida, United States, 32803
Actively Recruiting
26
Nova Psychiatry Inc. /ID# 270892
Orlando, Florida, United States, 32803
Actively Recruiting
27
Panhandle Research and Medical Clinic, LLC /ID# 268522
Pensacola, Florida, United States, 32502
Completed
28
D&H Tamarac Research Center /ID# 250434
Tamarac, Florida, United States, 33321-2979
Actively Recruiting
29
University of South Florida- Neuroscience Institute /ID# 246508
Tampa, Florida, United States, 33613
Completed
30
Atlanta Center for Medical Research /ID# 226480
Atlanta, Georgia, United States, 30331
Completed
31
CenExcel iResearch LLC /ID# 228695
Decatur, Georgia, United States, 30030
Actively Recruiting
32
Atlanta Behavioral Research, LLC /ID# 226486
Dunwoody, Georgia, United States, 30338
Actively Recruiting
33
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 226371
Stockbridge, Georgia, United States, 30281
Completed
34
Denali Health Atlanta, LLC /ID# 278167
Stone Mountain, Georgia, United States, 30083
Actively Recruiting
35
Duplicate_Ascension St. Elizabeth /ID# 240772
Chicago, Illinois, United States, 60622
Completed
36
Baber Research Group /ID# 232279
Naperville, Illinois, United States, 60563-6502
Completed
37
Advanced Quality Medical Research /ID# 272902
Orland Park, Illinois, United States, 60462
Actively Recruiting
38
Indiana University /ID# 260705
Indianapolis, Indiana, United States, 46202-3082
Actively Recruiting
39
Benchmark Research /ID# 260714
Shreveport, Louisiana, United States, 71101
Completed
40
The Kennedy Krieger Institute /ID# 226509
Baltimore, Maryland, United States, 21205
Actively Recruiting
41
Med Clinical Research Partners LLC /ID# 240773
Irvington, New Jersey, United States, 07111
Actively Recruiting
42
Duplicate_NeuroCognitive and Behavioral Institute, Inc /ID# 227077
Mount Arlington, New Jersey, United States, 07856-1315
Completed
43
UB Department of Psychiatry /ID# 226373
Buffalo, New York, United States, 14215
Completed
44
New Dawn Psychiatric Services PLLC /ID# 229782
Kinston, North Carolina, United States, 28501-1603
Completed
45
Quest Therapeutics of Avon Lake /ID# 226349
Avon Lake, Ohio, United States, 44012
Completed
46
University of Cincinnati /ID# 226465
Cincinnati, Ohio, United States, 45219
Completed
47
Cleveland Clinic - Cleveland /ID# 276309
Cleveland, Ohio, United States, 44195
Actively Recruiting
48
CincyScience /ID# 226318
West Chester, Ohio, United States, 45069
Actively Recruiting
49
IPS Research Company /ID# 227072
Oklahoma City, Oklahoma, United States, 73106
Completed
50
SP Research, PLLC /ID# 259428
Oklahoma City, Oklahoma, United States, 73112-8729
Completed
51
Cutting Edge Research Group /ID# 240777
Oklahoma City, Oklahoma, United States, 73116-1423
Completed
52
Paradigm Research Professionals /ID# 260719
Oklahoma City, Oklahoma, United States, 73116
Completed
53
Sooner Clinical Research /ID# 226384
Oklahoma City, Oklahoma, United States, 73116
Actively Recruiting
54
BioBehavioral Research of Austin /ID# 227076
Austin, Texas, United States, 78759
Completed
55
Beaumont Psychiatric Clinic /ID# 267484
Beaumont, Texas, United States, 77706
Actively Recruiting
56
Houston Clinical Trials - Bellaire /ID# 274189
Bellaire, Texas, United States, 77401
Actively Recruiting
57
Texas Research Group /ID# 270050
Coppell, Texas, United States, 75019
Actively Recruiting
58
Relaro Medical Trials /ID# 227156
Dallas, Texas, United States, 75243
Actively Recruiting
59
Earle Research /ID# 253782
Friendswood, Texas, United States, 77546
Actively Recruiting
60
McGovern Medical School /ID# 240779
Houston, Texas, United States, 77054
Completed
61
Southwest Biomed Research Center LLC /ID# 226340
Houston, Texas, United States, 77063
Completed
62
Kaleidoscope Clinical Research /ID# 277650
Houston, Texas, United States, 77089
Actively Recruiting
63
Red Oak Psychiatry Associates /ID# 240776
Houston, Texas, United States, 77090-2641
Completed
64
Livingspring Family Medical Center /ID# 262706
Mansfield, Texas, United States, 76063-5622
Actively Recruiting
65
Aim Trials /ID# 226367
Plano, Texas, United States, 75093
Actively Recruiting
66
Perceptive Pharma Research /ID# 262219
Richmond, Texas, United States, 77407
Actively Recruiting
67
Family Psychiatry of The Woodlands /ID# 226290
The Woodlands, Texas, United States, 77381
Actively Recruiting
68
Pantheon Clinical Research /ID# 270879
Bountiful, Utah, United States, 84010
Actively Recruiting
69
Core Clinical Research /ID# 226374
Everett, Washington, United States, 98201
Actively Recruiting
70
Dr. Samuel Sanchez PSC /ID# 245952
Caguas, Puerto Rico, 00727
Actively Recruiting
71
GCM Medical Group /ID# 245951
San Juan, Puerto Rico, 00917-3104
Actively Recruiting
72
Clinica of Glazunova /ID# 229416
Krasnodar, Krasnodarskiy Kray, Russia, 350051
Completed
73
Duplicate_Scientific Centre of Personalized Medicine /ID# 226380
Moscow, Moscow, Russia, 105082
Completed
74
Duplicate_Central Clinical Psychiatric Hospital /ID# 226381
Moscow, Moscow, Russia, 127083
Completed
75
Orenburg Regional Clinical Psychiatric Hospital #1 /ID# 226462
Orenburg, Orenburg Oblast, Russia, 460006
Completed
76
Psychotherapeutics Center Podderzhka /ID# 226348
Stavropol, Stavropol Kray, Russia, 355029
Completed
77
Clinical Psychiatry Hospital #1 of Nizhniy Novgorod /ID# 226226
Nizhny Novgorod, Russia, 603155
Completed
78
Psychiatric hospital #1 /ID# 226516
Saint Petersburg, Russia, 190121
Completed
79
National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 226515
Saint Petersburg, Russia, 192019
Completed
80
Medgard Clinic /ID# 228598
Saratov, Russia, 410028
Completed
81
Saratov City Clinical Hospital #2 n.a. V. I. Razumovsky /ID# 226222
Saratov, Russia, 410028
Completed
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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