A 6-week, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Cariprazine in Pediatric Subjects (10 to 17 Years of Age) in the Treatment of Depressive Episodes Associated With Bipolar I Disorder

Who is this study for? Pediatric patients with bipolar I disorder
What treatments are being studied? Cariprazine
Status: Recruiting
Location: See all (73) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 17
Healthy Volunteers: f
View:

• Participants with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) primary diagnosis of bipolar I disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and 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 and Visit 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) at Visit 1 and Visit 2.

Locations
United States
Arkansas
Pillar Clinical Research /ID# 226504
COMPLETED
Bentonville
California
Advanced Research Center /ID# 227073
RECRUITING
Anaheim
Care Access Research /ID# 226316
COMPLETED
Beverly Hills
ProScience Research Group /ID# 226223
COMPLETED
Culver City
National Institute of Clinical Research - Garden Grove /ID# 262835
RECRUITING
Garden Grove
Duplicate_Alliance for Research - Long Beach /ID# 226522
COMPLETED
Long Beach
ATP Clinical Research- Orange /ID# 253719
RECRUITING
Orange
CHOC Children's Hospital /ID# 260298
RECRUITING
Orange
Prospective Research Innovations Inc /ID# 240774
COMPLETED
Rancho Cucamonga
University of California Davis Health /ID# 268306
RECRUITING
Sacramento
University of California, San Diego Department of Psychiatry /ID# 226463
COMPLETED
San Diego
Lumos Clinical Research Center /ID# 262805
RECRUITING
San Jose
Pacific Clinical Research Management Group /ID# 227075
RECRUITING
Upland
Florida
D&H Doral Research Center-Doral /ID# 255458
RECRUITING
Doral
Advanced Research Institute of Miami /ID# 228222
RECRUITING
Homestead
Columbus Clinical Services, Llc /Id# 229792
RECRUITING
Miami
Florida Research Center, Inc. /ID# 240775
RECRUITING
Miami
G+C Research Group, LLC /ID# 261399
RECRUITING
Miami
South Florida Research Ph I-IV /ID# 240778
COMPLETED
Miami Springs
Medical Research Group of Central Florida /ID# 256757
RECRUITING
Orange City
APG Research, LLC /ID# 226519
RECRUITING
Orlando
Nova Psychiatry Inc. /ID# 270892
RECRUITING
Orlando
Panhandle Research and Medical Clinic, LLC /ID# 268522
RECRUITING
Pensacola
D&H Tamarac Research Center /ID# 250434
RECRUITING
Tamarac
University of South Florida- Neuroscience Institute /ID# 246508
COMPLETED
Tampa
Georgia
Atlanta Center for Medical Research /ID# 226480
COMPLETED
Atlanta
CenExcel iResearch LLC /ID# 228695
RECRUITING
Decatur
Atlanta Behavioral Research, LLC /ID# 226486
RECRUITING
Dunwoody
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 226371
COMPLETED
Stockbridge
Illinois
Ascension St. Elizabeth /ID# 240772
COMPLETED
Chicago
Baber Research Group /ID# 232279
COMPLETED
Naperville
Advanced Quality Medical Research /ID# 272902
RECRUITING
Orland Park
Indiana
Indiana University /ID# 260705
RECRUITING
Indianapolis
Louisiana
Benchmark Research /ID# 260714
RECRUITING
Shreveport
Maryland
The Kennedy Krieger Institute /ID# 226509
RECRUITING
Baltimore
North Carolina
New Dawn Psychiatric Services PLLC /ID# 229782
COMPLETED
Kinston
New Jersey
Med Clinical Research Partners LLC /ID# 240773
RECRUITING
Irvington
Duplicate_NeuroCognitive and Behavioral Institute, Inc /ID# 227077
COMPLETED
Mount Arlington
New York
UB Department of Psychiatry /ID# 226373
COMPLETED
Buffalo
Ohio
Quest Therapeutics of Avon Lake /ID# 226349
COMPLETED
Avon Lake
University of Cincinnati /ID# 226465
COMPLETED
Cincinnati
CincyScience /ID# 226318
RECRUITING
West Chester
Oklahoma
Cutting Edge Research Group /ID# 240777
COMPLETED
Oklahoma City
IPS Research Company /ID# 227072
COMPLETED
Oklahoma City
Paradigm Research Professionals /ID# 260719
COMPLETED
Oklahoma City
Sooner Clinical Research /ID# 226384
RECRUITING
Oklahoma City
SP Research, PLLC /ID# 259428
RECRUITING
Oklahoma City
Texas
BioBehavioral Research of Austin /ID# 227076
COMPLETED
Austin
Beaumont Psychiatric Clinic /ID# 267484
RECRUITING
Beaumont
Texas Research Group /ID# 270050
RECRUITING
Coppell
Relaro Medical Trials /ID# 227156
RECRUITING
Dallas
Earle Research /ID# 253782
RECRUITING
Friendswood
McGovern Medical School /ID# 240779
COMPLETED
Houston
Red Oak Psychiatry Associates /ID# 240776
COMPLETED
Houston
Southwest Biomed Research Center LLC /ID# 226340
COMPLETED
Houston
Livingspring Family Medical Center /ID# 262706
RECRUITING
Mansfield
AIM Trials /ID# 226367
RECRUITING
Plano
Perceptive Pharma Research /ID# 262219
RECRUITING
Richmond
Family Psychiatry of The Woodlands /ID# 226290
RECRUITING
The Woodlands
Utah
Pantheon Clinical Research /ID# 270879
RECRUITING
Bountiful
Washington
Core Clinical Research /ID# 226374
RECRUITING
Everett
Other Locations
Puerto Rico
Dr. Samuel Sanchez PSC /ID# 245952
RECRUITING
Caguas
GCM Medical Group PSC /ID# 245951
RECRUITING
San Juan
Russian Federation
Clinica of Glazunova /ID# 229416
COMPLETED
Krasnodar
Central Clinical Psychiatric Hospital /ID# 226381
COMPLETED
Moscow
Scientific Centre of Personalized Medicine /ID# 226380
COMPLETED
Moscow
Clinical Psychiatry Hospital #1 of Nizhniy Novgorod /ID# 226226
COMPLETED
Nizhny Novgorod
Orenburg Regional Clinical Psychiatric Hospital #1 /ID# 226462
COMPLETED
Orenburg
National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 226515
COMPLETED
Saint Petersburg
Psychiatric hospital #1 /ID# 226516
COMPLETED
Saint Petersburg
Medgard Clinic /ID# 228598
COMPLETED
Saratov
Saratov City Clinical Hospital #2 n.a. V. I. Razumovsky /ID# 226222
COMPLETED
Saratov
Psychotherapeutics Center Podderzhka /ID# 226348
COMPLETED
Stavropol
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2021-04-28
Estimated Completion Date: 2027-03
Participants
Target number of participants: 380
Treatments
Placebo_comparator: Placebo
Participants will receive Placebo over a 6 week treatment period.
Experimental: Cariprazine
Participants will receive flexible dose Cariprazine over a 6 week treatment period.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov