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.

March 5, 2024 updated by: AbbVie

A 6-week, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Cariprazine in Pediatric Participants (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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

380

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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 PSC /ID# 245951
  • Russian Federation
      • Moscow, Russian Federation, 105082
        • Completed
        • Scientific Centre of Personalized Medicine /ID# 226380
      • Moscow, Russian Federation, 127083
        • Completed
        • Central Clinical Psychiatric Hospital /ID# 226381
      • Nizhny Novgorod, Russian Federation, 603155
        • Completed
        • Clinical Psychiatry Hospital #1 of Nizhniy Novgorod /ID# 226226
      • Orenburg, Russian Federation, 460006
        • Completed
        • Orenburg Regional Clinical Psychiatric Hospital #1 /ID# 226462
      • Saratov, Russian Federation, 410028
        • Completed
        • Medgard Clinic /ID# 228598
      • Saratov, Russian Federation, 410028
        • Completed
        • Saratov City Clinical Hospital #2 n.a. V. I. Razumovsky /ID# 226222
      • St. Petersburg, Russian Federation, 190121
        • Completed
        • Psychiatric hospital #1 /ID# 226516
      • St. Petersburg, Russian Federation, 192019
        • Completed
        • National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev /ID# 226515
    • Krasnodarskiy Kray
      • Krasnodar, Krasnodarskiy Kray, Russian Federation, 350051
        • Completed
        • Clinica of Glazunova /ID# 229416
    • Stavropol Skiy Kray
      • Stavropol, Stavropol Skiy Kray, Russian Federation, 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
      • Culver City, California, United States, 90230-6632
        • Completed
        • ProScience Research Group /ID# 226223
      • Long Beach, California, United States, 90807
        • Completed
        • Alliance for Research - Long Beach /ID# 226522
      • Orange, California, United States, 92868
        • Recruiting
        • ATP Clinical Research- Orange /ID# 253719
      • Rancho Cucamonga, California, United States, 91730
        • Recruiting
        • Prospective Research Innovations Inc /ID# 240774
      • San Diego, California, United States, 92103-8229
        • Completed
        • University of California, San Diego Department of Psychiatry /ID# 226463
      • Upland, California, United States, 91786-3676
        • Recruiting
        • Pacific Clinical Research Management Group /ID# 227075
    • Florida
      • Doral, Florida, United States, 33122
        • Recruiting
        • D&H Doral Research Center-Doral /ID# 255458
      • Homestead, Florida, United States, 33030-4613
        • Recruiting
        • Advanced Research Institute of Miami /ID# 228222
      • Miami, Florida, United States, 33125-5114
        • Recruiting
        • Columbus Clinical Services, Llc /Id# 229792
      • 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 Springs, Florida, United States, 33166-7225
        • Recruiting
        • 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
        • APG Research, LLC /ID# 226519
      • Tamarac, Florida, United States, 33321-2979
        • Recruiting
        • D&H Tamarac Research Center /ID# 250434
      • Tampa, Florida, United States, 33612-2201
        • Recruiting
        • University of South Florida /ID# 246508
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Recruiting
        • 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
        • Recruiting
        • Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 226371
    • Illinois
      • Chicago, Illinois, United States, 60622
        • Recruiting
        • Ascension St. Elizabeth /ID# 240772
      • Naperville, Illinois, United States, 60563-6502
        • Completed
        • Baber Research Group /ID# 232279
    • 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
        • NeuroCognitive and Behavioral Institute, Inc /ID# 227077
    • New York
      • Buffalo, New York, United States, 14215
        • Recruiting
        • UB Department of Psychiatry /ID# 226373
    • North Carolina
      • Kinston, North Carolina, United States, 28501-1603
        • Recruiting
        • New Dawn Psychiatric Services PLLC /ID# 229782
    • Ohio
      • Avon Lake, Ohio, United States, 44012
        • Recruiting
        • Quest Therapeutics of Avon Lake /ID# 226349
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati /ID# 226465
      • 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, 73112
        • Recruiting
        • Sooner Clinical Research /ID# 226384
      • Oklahoma City, Oklahoma, United States, 73116-1423
        • Recruiting
        • Cutting Edge Research Group /ID# 240777
      • Oklahoma City, Oklahoma, United States, 73112-8729
        • Recruiting
        • SP Research, PLLC /ID# 259428
    • Texas
      • Austin, Texas, United States, 78759-5290
        • Recruiting
        • BioBehavioral Research of Austin /ID# 227076
      • 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, 77090-2641
        • Recruiting
        • Red Oak Psychiatry Associates /ID# 240776
      • Houston, Texas, United States, 77054
        • Completed
        • McGovern Medical School /ID# 240779
      • Plano, Texas, United States, 75093
        • Recruiting
        • AIM Trials /ID# 226367
      • The Woodlands, Texas, United States, 77381
        • Recruiting
        • Family Psychiatry of The Woodlands /ID# 226290
    • Washington
      • Everett, Washington, United States, 98201
        • Recruiting
        • Core Clinical Research /ID# 226374

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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.
  • Participants with cataracts, ocular trauma, ocular disease, history of amiodarone or systemic corticosteroid use for >= 3 consecutive months in the past year, and IOP of >= 21 mm Hg in either eye.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Baseline (Week 0) to Week 10
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
Time Frame: Baseline (Week 0) to Week 10
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
Time Frame: Baseline (Week 0) to Week 6
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)
Time Frame: Baseline (Week 0) to Week 6
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 in Children's Depression Rating Scale - Revised (CDRS-S) Total Score
Time Frame: Baseline (Week 0) to Week 6
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

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2021

Primary Completion (Estimated)

January 29, 2025

Study Completion (Estimated)

January 29, 2025

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)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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 data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on 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
  • CSR

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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