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.

Launched by ABBVIE · Feb 26, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a medication called cariprazine to see how well it works for treating depressive episodes in children and teenagers aged 10 to 17 who have bipolar I disorder. Bipolar disorder is a condition that can cause extreme mood swings, including depression and mania. While cariprazine is already approved for adults, this study aims to learn more about its effects and safety in younger patients, as treatments for pediatric bipolar depression are not as well understood.

To participate, children must have a confirmed diagnosis of bipolar I disorder and be currently experiencing a depressive episode lasting more than two weeks but less than a year. Participants will be randomly assigned to receive either cariprazine or a placebo (a non-active treatment). They will attend weekly visits for about three months, during which their health will be monitored through assessments, blood tests, and questionnaires. Parents and guardians should know that there may be more visits and evaluations than usual compared to standard care. Overall, this trial hopes to provide valuable information about how to better treat depression in young people with bipolar disorder.

Gender

ALL

Eligibility criteria

• 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).

Trial Officials