Status:
RECRUITING
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.
Lead Sponsor:
AbbVie
Conditions:
Depression
Bipolar I Disorder
Eligibility:
All Genders
10-17 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT04777357
Start Date
April 28 2021
End Date
March 1 2027
Last Update
December 19 2025
Active Locations (75)
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1
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