A Study of the Change in Disease State and Safety of Oral Cariprazine Capsules in the Treatment of Depression in Pediatric Participants (10 to 17 Years of Age) With Bipolar I Disorder

  • End date
    Jan 18, 2024
  • participants needed
  • sponsor
Updated on 24 October 2021
depressed mood
depressive episode
mood 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.

Condition Endogenous depression, Depression, Bipolar I Disorder, Depressed, depressive disorder, depressed mood, miserable, depressive disorders
Treatment Placebo, cariprazine
Clinical Study IdentifierNCT04777357
Last Modified on24 October 2021


Yes No Not Sure

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 4 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 <
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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