Summary

Eligibility
for people ages 10-17 (full criteria)
Location
at UC Davis UCSD
Dates
study started
study ends around

Description

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.

Official Title

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

Keywords

Depression, Bipolar I Disorder, RGH-188, Vraylar, Cariprazine, Counterfeit Drugs

Eligibility

You can join if…

Open to people ages 10-17

  • 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 CAN'T join 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).

Locations

  • University of California Davis Health /ID# 268306 accepting new patients
    Sacramento 5389489 California 5332921 95817 United States
  • University of California, San Diego Department of Psychiatry /ID# 226463 completed
    San Diego 5391811 California 5332921 92103-8229 United States
  • Care Access Research /ID# 226316 completed
    Beverly Hills 5328041 California 5332921 90212 United States
  • ProScience Research Group /ID# 226223 completed
    Culver City 5341114 California 5332921 90230-6632 United States
  • CHOC Children's Hospital /ID# 260298 accepting new patients
    Orange 5379513 California 5332921 92868-4203 United States
  • ATP Clinical Research- Orange /ID# 253719 accepting new patients
    Orange 5379513 California 5332921 92868 United States
  • National Institute of Clinical Research - Garden Grove /ID# 262835 accepting new patients
    Garden Grove 5351515 California 5332921 92844 United States
  • Advanced Research Center /ID# 227073 accepting new patients
    Anaheim 5323810 California 5332921 92805 United States
  • Duplicate_Alliance for Research - Long Beach /ID# 226522 completed
    Long Beach 5367929 California 5332921 90807 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
Related Info
ID
NCT04777357
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 380 study participants
Last Updated