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.

NCT04777357 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 3112-301-0012020-004758-32
• Study Type: interventional
• Target: 380
• Locations: 3 countries
• Sites: 80

Brief 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.

Conditions

Depression; Bipolar I Disorder

Keywords

Depression; RGH-188; Bipolar I Disorder; Vraylar; Cariprazine

Outcome Measures

Primary Outcomes (9)

• 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 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 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 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 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

Study Arms (2)

Cariprazine

EXPERIMENTAL

Participants will receive flexible dose Cariprazine over a 6 week treatment period.

Drug: Cariprazine

Placebo

PLACEBO COMPARATOR

Participants will receive Placebo over a 6 week treatment period.

Drug: Placebo

Interventions

Cariprazine DRUG

Oral Capsule

Also known as: Vraylar

Cariprazine

Placebo DRUG

Oral Capsule

Placebo

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• AbbVie: lead

Study Sites (80)

Pillar Clinical Research /ID# 226504

Bentonville, Arkansas, 72712, United States

COMPLETED

Advanced Research Center /ID# 227073

Anaheim, California, 92805, United States

RECRUITING

Care Access Research /ID# 226316

Beverly Hills, California, 90212, United States

COMPLETED

Inland Pyschiatric Medical Group - Chino /ID# 278667

Chino, California, 91710, United States

RECRUITING

ProScience Research Group /ID# 226223

Culver City, California, 90230-6632, United States

COMPLETED

National Institute of Clinical Research - Garden Grove /ID# 262835

Garden Grove, California, 92844, United States

COMPLETED

Duplicate_Alliance for Research - Long Beach /ID# 226522

Long Beach, California, 90807, United States

COMPLETED

CHOC Children's Hospital /ID# 260298

Orange, California, 92868-4203, United States

RECRUITING

ATP Clinical Research- Orange /ID# 253719

Orange, California, 92868, United States

RECRUITING

Prospective Research Innovations Inc /ID# 240774

Rancho Cucamonga, California, 91730, United States

COMPLETED

Inland Psychiatric Medical Group /ID# 274621

Redlands, California, 92373, United States

RECRUITING

University of California Davis Health /ID# 268306

Sacramento, California, 95817, United States

RECRUITING

University of California, San Diego Department of Psychiatry /ID# 226463

San Diego, California, 92103-8229, United States

COMPLETED

Lumos Clinical Research Center /ID# 262805

San Jose, California, 95124-4108, United States

RECRUITING

Pacific Clinical Research Management Group /ID# 227075

Upland, California, 91786, United States

COMPLETED

Next Level Clinical Trials /ID# 277152

West Covina, California, 91790, United States

RECRUITING

D&H Doral Research Center-Doral /ID# 255458

Doral, Florida, 33122, United States

RECRUITING

Advanced Research Institute of Miami /ID# 228222

Homestead, Florida, 33030-4613, United States

RECRUITING

Columbus Clinical Services, Llc /Id# 229792

Miami, Florida, 33125, United States

COMPLETED

G+C Research Group, LLC /ID# 261399

Miami, Florida, 33126-2018, United States

RECRUITING

Florida Research Center, Inc. /ID# 240775

Miami, Florida, 33174, United States

RECRUITING

South Florida Research Ph I-IV /ID# 240778

Miami Springs, Florida, 33166-7225, United States

COMPLETED

Medical Research Group of Central Florida /ID# 256757

Orange City, Florida, 32763, United States

RECRUITING

APG Research, LLC /ID# 226519

Orlando, Florida, 32803, United States

RECRUITING

Nova Psychiatry Inc. /ID# 270892

Orlando, Florida, 32803, United States

RECRUITING

Panhandle Research and Medical Clinic, LLC /ID# 268522

Pensacola, Florida, 32502, United States

COMPLETED

D&H Tamarac Research Center /ID# 250434

Tamarac, Florida, 33321-2979, United States

RECRUITING

University of South Florida- Neuroscience Institute /ID# 246508

Tampa, Florida, 33613, United States

COMPLETED

Atlanta Center for Medical Research /ID# 226480

Atlanta, Georgia, 30331, United States

COMPLETED

CenExcel iResearch LLC /ID# 228695

Decatur, Georgia, 30030, United States

RECRUITING

Atlanta Behavioral Research, LLC /ID# 226486

Dunwoody, Georgia, 30338, United States

RECRUITING

Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 226371

Stockbridge, Georgia, 30281, United States

COMPLETED

Denali Health Atlanta, LLC /ID# 278167

Stone Mountain, Georgia, 30083, United States

RECRUITING

Duplicate_Ascension St. Elizabeth /ID# 240772

Chicago, Illinois, 60622, United States

COMPLETED

Baber Research Group /ID# 232279

Naperville, Illinois, 60563-6502, United States

COMPLETED

Advanced Quality Medical Research /ID# 272902

Orland Park, Illinois, 60462, United States

RECRUITING

Indiana University /ID# 260705

Indianapolis, Indiana, 46202-3082, United States

RECRUITING

Benchmark Research /ID# 260714

Shreveport, Louisiana, 71101, United States

COMPLETED

The Kennedy Krieger Institute /ID# 226509

Baltimore, Maryland, 21205, United States

RECRUITING

Med Clinical Research Partners LLC /ID# 240773

Irvington, New Jersey, 07111, United States

RECRUITING

Duplicate_NeuroCognitive and Behavioral Institute, Inc /ID# 227077

Mount Arlington, New Jersey, 07856-1315, United States

COMPLETED

UB Department of Psychiatry /ID# 226373

Buffalo, New York, 14215, United States

COMPLETED

New Dawn Psychiatric Services PLLC /ID# 229782

Kinston, North Carolina, 28501-1603, United States

COMPLETED

Quest Therapeutics of Avon Lake /ID# 226349

Avon Lake, Ohio, 44012, United States

COMPLETED

University of Cincinnati /ID# 226465

Cincinnati, Ohio, 45219, United States

COMPLETED

Cleveland Clinic - Cleveland /ID# 276309

Cleveland, Ohio, 44195, United States

RECRUITING

CincyScience /ID# 226318

West Chester, Ohio, 45069, United States

RECRUITING

IPS Research Company /ID# 227072

Oklahoma City, Oklahoma, 73106, United States

COMPLETED

SP Research, PLLC /ID# 259428

Oklahoma City, Oklahoma, 73112-8729, United States

COMPLETED

Cutting Edge Research Group /ID# 240777

Oklahoma City, Oklahoma, 73116-1423, United States

COMPLETED

Paradigm Research Professionals /ID# 260719

Oklahoma City, Oklahoma, 73116, United States

COMPLETED

Sooner Clinical Research /ID# 226384

Oklahoma City, Oklahoma, 73116, United States

RECRUITING

BioBehavioral Research of Austin /ID# 227076

Austin, Texas, 78759, United States

COMPLETED

Beaumont Psychiatric Clinic /ID# 267484

Beaumont, Texas, 77706, United States

RECRUITING

Houston Clinical Trials - Bellaire /ID# 274189

Bellaire, Texas, 77401, United States

RECRUITING

Texas Research Group /ID# 270050

Coppell, Texas, 75019, United States

RECRUITING

Relaro Medical Trials /ID# 227156

Dallas, Texas, 75243, United States

RECRUITING

Earle Research /ID# 253782

Friendswood, Texas, 77546, United States

RECRUITING

McGovern Medical School /ID# 240779

Houston, Texas, 77054, United States

COMPLETED

Southwest Biomed Research Center LLC /ID# 226340

Houston, Texas, 77063, United States

COMPLETED

Kaleidoscope Clinical Research /ID# 277650

Houston, Texas, 77089, United States

RECRUITING

Red Oak Psychiatry Associates /ID# 240776

Houston, Texas, 77090-2641, United States

COMPLETED

Livingspring Family Medical Center /ID# 262706

Mansfield, Texas, 76063-5622, United States

RECRUITING

AIM Trials /ID# 226367

Plano, Texas, 75093, United States

RECRUITING

Perceptive Pharma Research /ID# 262219

Richmond, Texas, 77407, United States

RECRUITING

Family Psychiatry of The Woodlands /ID# 226290

The Woodlands, Texas, 77381, United States

RECRUITING

Pantheon Clinical Research /ID# 270879

Bountiful, Utah, 84010, United States

RECRUITING

Core Clinical Research /ID# 226374

Everett, Washington, 98201, United States

RECRUITING

Dr. Samuel Sanchez PSC /ID# 245952

Caguas, 00727, Puerto Rico

RECRUITING

GCM Medical Group PSC /ID# 245951

San Juan, 00917-3104, Puerto Rico

RECRUITING

Clinica of Glazunova /ID# 229416

Krasnodar, Krasnodarskiy Kray, 350051, Russia

COMPLETED

Duplicate_Scientific Centre of Personalized Medicine /ID# 226380

Moscow, Moscow, 105082, Russia

COMPLETED

Duplicate_Central Clinical Psychiatric Hospital /ID# 226381

Moscow, Moscow, 127083, Russia

COMPLETED

Orenburg Regional Clinical Psychiatric Hospital #1 /ID# 226462

Orenburg, Orenburg Oblast, 460006, Russia

COMPLETED

Psychotherapeutics Center Podderzhka /ID# 226348

Stavropol, Stavropol Kray, 355029, Russia

COMPLETED

Clinical Psychiatry Hospital #1 of Nizhniy Novgorod /ID# 226226

Nizhny Novgorod, 603155, Russia

COMPLETED

Psychiatric hospital #1 /ID# 226516

Saint Petersburg, 190121, Russia

COMPLETED

National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 226515

Saint Petersburg, 192019, Russia

COMPLETED

Medgard Clinic /ID# 228598

Saratov, 410028, Russia

COMPLETED

Saratov City Clinical Hospital #2 n.a. V. I. Razumovsky /ID# 226222

Saratov, 410028, Russia

COMPLETED

Related Links

• Related Info

MeSH Terms

Conditions

Depression

Interventions

cariprazine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 2, 2021
• Study Start: April 28, 2021
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

RU (10); US (68); PR (2)