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. (3112 Ped BPD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Bipolar I Disorder
• Intervention / Treatment: Drug: Placebo; Drug: Cariprazine

• Study Type: Interventional
• Enrollment (Estimated): 380
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Puerto Rico
  • Caguas, Puerto Rico, 00727
    • Recruiting
    • Dr. Samuel Sanchez PSC /ID# 245952
  • San Juan, Puerto Rico, 00917-3104
    • Recruiting
    • GCM Medical Group /ID# 245951
• Russia
  • Nizhny Novgorod, Russia, 603155
    • Completed
    • Clinical Psychiatry Hospital #1 of Nizhniy Novgorod /ID# 226226
  • Saint Petersburg, Russia, 190121
    • Completed
    • Psychiatric hospital #1 /ID# 226516
  • Saint Petersburg, Russia, 192019
    • Completed
    • National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 226515
  • Saratov, Russia, 410028
    • Completed
    • Medgard Clinic /ID# 228598
  • Saratov, Russia, 410028
    • Completed
    • Saratov City Clinical Hospital #2 n.a. V. I. Razumovsky /ID# 226222
  • Krasnodarskiy Kray
    • Krasnodar, Krasnodarskiy Kray, Russia, 350051
      • Completed
      • Clinica of Glazunova /ID# 229416
  • Moscow
    • Moscow, Moscow, Russia, 105082
      • Completed
      • Duplicate_Scientific Centre of Personalized Medicine /ID# 226380
    • Moscow, Moscow, Russia, 127083
      • Completed
      • Duplicate_Central Clinical Psychiatric Hospital /ID# 226381
  • Orenburg Oblast
    • Orenburg, Orenburg Oblast, Russia, 460006
      • Completed
      • Orenburg Regional Clinical Psychiatric Hospital #1 /ID# 226462
  • Stavropol Kray
    • Stavropol, Stavropol Kray, Russia, 355029
      • Completed
      • Psychotherapeutics Center Podderzhka /ID# 226348
• United States
  • Arkansas
    • Bentonville, Arkansas, United States, 72712
      • Completed
      • Pillar Clinical Research /ID# 226504
  • California
    • Anaheim, California, United States, 92805
      • Recruiting
      • Advanced Research Center /ID# 227073
    • Beverly Hills, California, United States, 90212
      • Completed
      • Care Access Research /ID# 226316
    • Chino, California, United States, 91710
      • Recruiting
      • Inland Pyschiatric Medical Group - Chino /ID# 278667
    • Culver City, California, United States, 90230-6632
      • Completed
      • ProScience Research Group /ID# 226223
    • Garden Grove, California, United States, 92844
      • Completed
      • National Institute of Clinical Research - Garden Grove /ID# 262835
    • Long Beach, California, United States, 90807
      • Completed
      • Duplicate_Alliance for Research - Long Beach /ID# 226522
    • Long Beach, California, United States, 90807
      • Recruiting
      • Accellacare - Long Beach /ID# 279482
    • Orange, California, United States, 92868
      • Recruiting
      • ATP Clinical Research- Orange /ID# 253719
    • Orange, California, United States, 92868-4203
      • Recruiting
      • CHOC Children's Hospital /ID# 260298
    • Rancho Cucamonga, California, United States, 91730
      • Completed
      • Prospective Research Innovations Inc /ID# 240774
    • Redlands, California, United States, 92373
      • Recruiting
      • Inland Psychiatric Medical Group /ID# 274621
    • Sacramento, California, United States, 95817
      • Recruiting
      • University of California Davis Health /ID# 268306
      • Contact: Site Coordinator; Phone Number: 916-734-3574; Email: cqthai@health.ucdavis.edu
    • San Diego, California, United States, 92103-8229
      • Completed
      • University of California, San Diego Department of Psychiatry /ID# 226463
    • San Jose, California, United States, 95124-4108
      • Completed
      • Lumos Clinical Research Center /ID# 262805
    • Upland, California, United States, 91786
      • Completed
      • Pacific Clinical Research Management Group /ID# 227075
    • West Covina, California, United States, 91790
      • Recruiting
      • Next Level Clinical Trials /ID# 277152
      • Contact: Site Coordinator; Phone Number: 773-424-2430; Email: jemmanuella@nextleveltrials.com
  • Florida
    • Doral, Florida, United States, 33122
      • Recruiting
      • D&H Doral Research Center-Doral /ID# 255458
    • Homestead, Florida, United States, 33030-4613
      • Completed
      • Advanced Research Institute of Miami /ID# 228222
    • Miami, Florida, United States, 33174
      • Recruiting
      • Florida Research Center, Inc. /ID# 240775
    • Miami, Florida, United States, 33126-2018
      • Recruiting
      • G+C Research Group, LLC /ID# 261399
    • Miami, Florida, United States, 33125
      • Completed
      • Columbus Clinical Services, Llc /Id# 229792
    • Miami Springs, Florida, United States, 33166-7225
      • Completed
      • South Florida Research Ph I-IV /ID# 240778
    • Orange City, Florida, United States, 32763
      • Recruiting
      • Medical Research Group of Central Florida /ID# 256757
    • Orlando, Florida, United States, 32803
      • Recruiting
      • Nova Psychiatry Inc. /ID# 270892
    • Orlando, Florida, United States, 32803
      • Completed
      • APG Research, LLC /ID# 226519
    • Pensacola, Florida, United States, 32502
      • Completed
      • Panhandle Research and Medical Clinic, LLC /ID# 268522
    • Tamarac, Florida, United States, 33321-2979
      • Recruiting
      • D&H Tamarac Research Center /ID# 250434
    • Tampa, Florida, United States, 33613
      • Completed
      • University of South Florida- Neuroscience Institute /ID# 246508
  • Georgia
    • Atlanta, Georgia, United States, 30331
      • Completed
      • Atlanta Center for Medical Research /ID# 226480
    • Decatur, Georgia, United States, 30030
      • Recruiting
      • CenExcel iResearch LLC /ID# 228695
    • Dunwoody, Georgia, United States, 30338
      • Recruiting
      • Atlanta Behavioral Research, LLC /ID# 226486
    • Stockbridge, Georgia, United States, 30281
      • Completed
      • Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 226371
    • Stone Mountain, Georgia, United States, 30083
      • Recruiting
      • Denali Health Atlanta, LLC /ID# 278167
  • Illinois
    • Chicago, Illinois, United States, 60622
      • Completed
      • Duplicate_Ascension St. Elizabeth /ID# 240772
    • Naperville, Illinois, United States, 60563-6502
      • Completed
      • Baber Research Group /ID# 232279
    • Orland Park, Illinois, United States, 60462
      • Recruiting
      • Advanced Quality Medical Research /ID# 272902
  • Indiana
    • Indianapolis, Indiana, United States, 46202-3082
      • Completed
      • Indiana University /ID# 260705
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Completed
      • Benchmark Research /ID# 260714
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Recruiting
      • The Kennedy Krieger Institute /ID# 226509
  • New Jersey
    • Irvington, New Jersey, United States, 07111
      • Recruiting
      • Med Clinical Research Partners LLC /ID# 240773
    • Mount Arlington, New Jersey, United States, 07856-1315
      • Completed
      • Duplicate_NeuroCognitive and Behavioral Institute, Inc /ID# 227077
  • New York
    • Buffalo, New York, United States, 14215
      • Completed
      • UB Department of Psychiatry /ID# 226373
  • North Carolina
    • Kinston, North Carolina, United States, 28501-1603
      • Completed
      • New Dawn Psychiatric Services PLLC /ID# 229782
  • Ohio
    • Avon Lake, Ohio, United States, 44012
      • Completed
      • Quest Therapeutics of Avon Lake /ID# 226349
    • Cincinnati, Ohio, United States, 45219
      • Completed
      • University of Cincinnati /ID# 226465
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic - Cleveland /ID# 276309
    • West Chester, Ohio, United States, 45069
      • Recruiting
      • CincyScience /ID# 226318
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73106
      • Completed
      • IPS Research Company /ID# 227072
    • Oklahoma City, Oklahoma, United States, 73116
      • Recruiting
      • Sooner Clinical Research /ID# 226384
    • Oklahoma City, Oklahoma, United States, 73116-1423
      • Completed
      • Cutting Edge Research Group /ID# 240777
    • Oklahoma City, Oklahoma, United States, 73116
      • Completed
      • Paradigm Research Professionals /ID# 260719
    • Oklahoma City, Oklahoma, United States, 73112-8729
      • Completed
      • SP Research, PLLC /ID# 259428
  • Texas
    • Austin, Texas, United States, 78759
      • Completed
      • BioBehavioral Research of Austin /ID# 227076
    • Beaumont, Texas, United States, 77706
      • Recruiting
      • Beaumont Psychiatric Clinic /ID# 267484
    • Bellaire, Texas, United States, 77401
      • Recruiting
      • Houston Clinical Trials - Bellaire /ID# 274189
    • Coppell, Texas, United States, 75019
      • Recruiting
      • Texas Research Group /ID# 270050
    • Dallas, Texas, United States, 75243
      • Recruiting
      • Relaro Medical Trials /ID# 227156
    • Friendswood, Texas, United States, 77546
      • Recruiting
      • Earle Research /ID# 253782
    • Houston, Texas, United States, 77063
      • Completed
      • Southwest Biomed Research Center LLC /ID# 226340
    • Houston, Texas, United States, 77054
      • Completed
      • McGovern Medical School /ID# 240779
    • Houston, Texas, United States, 77090-2641
      • Completed
      • Red Oak Psychiatry Associates /ID# 240776
    • Houston, Texas, United States, 77089
      • Recruiting
      • Kaleidoscope Clinical Research /ID# 277650
      • Contact: Site Coordinator; Phone Number: 832-969-6157; Email: sekeia.willis@sclamanagement.com
    • Mansfield, Texas, United States, 76063-5622
      • Recruiting
      • Livingspring Family Medical Center /ID# 262706
    • Plano, Texas, United States, 75093
      • Recruiting
      • Aim Trials /ID# 226367
      • Contact: Site Coordinator; Phone Number: 214-856-2778
    • Richmond, Texas, United States, 77407
      • Recruiting
      • Perceptive Pharma Research /ID# 262219
    • The Woodlands, Texas, United States, 77381
      • Recruiting
      • Family Psychiatry of The Woodlands /ID# 226290
  • Utah
    • Bountiful, Utah, United States, 84010
      • Recruiting
      • Pantheon Clinical Research /ID# 270879
  • Washington
    • Everett, Washington, United States, 98201
      • Recruiting
      • Core Clinical Research /ID# 226374

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Participants with DSM-5 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.
• Participant has a history of meeting DSM-5 diagnosis for any substance-related disorder (except caffeine- and tobacco-related) within the 3 months before Screening Visit 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, or documented 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 that predisposes to seizures.
• Participant requires concomitant treatment with moderate or strong CYP3A4 inhibitors or with any CYP3A4 inducers.
• Participant requires concomitant treatment with any prohibited medication, supplement, or herbal product, including any psychotropic drug or any drug with psychotropic activity or with a potentially psychotropic component.
• Use of a depot antipsychotic within 2 cycles of their respective dosing interval prior 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, retinal detachment, intraocular surgery, laser treatment, glaucoma, cataracts, or clinically significant ocular trauma (with the exception of refractive errors).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will receive Placebo over a 6 week treatment period.	Drug: Placebo; Oral Capsule
Experimental: Cariprazine; Participants will receive flexible dose Cariprazine over a 6 week treatment period.	Drug: Cariprazine; Oral Capsule; Other Names: Vraylar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a casual relationship with this treatment. The investigator assesses the relationship of each event to the use of the study. A serious adverse event (SAE) is an event that results in death, is life threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event, that based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/ treatment emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of the study drug.	Baseline (Week 0) to Week 10
Abnormal Change from Baseline in Vital Signs	Change in vital signs like systolic and diastolic blood pressure will be assessed.	Baseline (Week 0) to Week 10
Number of Participants with Incidence of Abnormal Clinical Laboratory Test Results	Number of participants with incidence of abnormal clinical laboratory test results like hematology will be assessed.	Baseline (Week 0) to Week 6
Change in Electrocardiogram (ECG)	12 -lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.	Baseline (Week 0) to Week 6
Change From Baseline in Simpson-Angus Scale (SAS)	SAS is a 10-item rating scale for assessment of antipsychotic-induced parkinsonism in both clinical practice and research settings. Each item ranges from 0 (normal) to 4 (extreme symptoms). The scale consists of 1 item measuring gait (hypokinesia), 6 items measuring rigidity, and 3 items measuring glabella tap, tremor, and salivation, respectively.	Baseline (Week 0) to Week 6
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)	AIMS assesses abnormal involuntary movements, such as tardive dyskinesia, associated with antipsychotic drugs; it measures facial, oral, extremities, and trunk movements, as well as the participant's awareness of abnormal movements. The first 10 items are rated on a none (0) to severe (4) scale. There are an additional 2 items on dental status that are answered yes or no.	Baseline (Week 0) to Week 6
Change From Baseline in Barnes Akathisia Rating Scale (BARS)	BARS is a 4-item rating scale used to assess drug-induced akathisia. The scale comprises items for rating the observable restless movements that characterize the condition, the subjective awareness of restlessness, and any distress associated with the akathisia (each on a 4-point scale from normal [0] to severe [3]). In addition, there is a global severity for akathisia rated on a 6-point scale (absent [0] to severe akathisia [5]).	Baseline (Week 0) to Week 6
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)	The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior, with a higher score denoting more severe suicidal ideation and behavior.	Baseline (Week 0) to Week 10
Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score	The CDRS-R is a 17-item clinician-administered scale specifically developed for the assessment of depressive symptoms in children and adolescents. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. The CDRS-R will be administered by a clinician with extensive professional training in mental illness.	Baseline (Week 0) to Week 6

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2021
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 2, 2021

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Bipolar I Disorder; Cariprazine; RGH-188; Vraylar
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression; Substandard Drugs; Pharmaceutical Preparations; cariprazine
• Other Study ID Numbers: 3112-301-001; 2020-004758-32 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No