Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia or Bipolar I Disorder

• Status: Recruiting
• Trial end date: 2023-06-06
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the long-term safety and tolerability of cariprazine in the treatment of pediatric participants with schizophrenia or bipolar I disorder, and to establish the benefit-risk profile of long-term treatment in this population.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: Cariprazine

Criteria

Inclusion Criteria:

• Participants with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) primary diagnosis of schizophrenia or bipolar I disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).

• Participant must have normal physical examination findings, clinical laboratory test results, and ECG results at Screening Visit 1, or from the last visit of respective lead-in study, or abnormal results that are determined to be not clinically significant by the investigator.

• Negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test (all female participants).

• Participants (if reached his spermarche or her menarche) and is sexually active, must agree to sexual abstinence or to use an approved birth control method for the full duration of participation in the study. The investigator and each participant will determine the appropriate method of contraception for the participant during their participation in the study.

• Parent(s) or participant's legal representative(s) must be capable of giving signed Informed Consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol as explained by the investigator. Written informed consent from the Parent(s) or participant's legal representative(s) must be obtained prior to any study-related procedures.

• Informed assent (unless local regulations require consent) must be obtained for all participants before eligibility evaluation for enrollment in the study.

• For 10-11-year-old participants, a different assent form will be used than that for 12-17-year-old participants.

• Participant must have a caregiver (parent or legally authorized representative) who is willing and able to be responsible for safety monitoring of the participant, provide information about the participant's condition, oversee administration of study intervention, and accompany the participant to all study visits.

• Participant must be able to swallow the study intervention.

Exclusion Criteria:

• Participants with DSM-5 diagnosis of schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition.

• DSM-5 diagnosis of intellectual disability (IQ < 70).

• 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) of the respective lead-in study, and/or within the 3 months before Visit 1 of this open-label (OL) study.

• Participant with an acute or unstable medical condition, including (but not limited to) inadequately controlled diabetes, hepatic insufficiency (specifically any degree of jaundice), uncorrected hyper- or hypo-thyroidism, acute systemic infection, renal, gastrointestinal, respiratory, or cardiovascular disease.

• Severe head trauma.

• History of seizures, with the exception of febrile seizures.

• History of tumor of the central nervous system.

• Participant requires concomitant treatment with strong CYP3A4 inhibitors or CYP3A4 inducers. If applicable, these drugs must be discontinued 7 days prior to Baseline (Visit 2).

• 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, with the exception of permitted interventions.

• Use of an antipsychotic depot within 2 cycles of their respective dosing interval prior to Screening (Visit 1).

• Participant requires initiation or termination of psychotherapy within the 3 months preceding Screening (Visit 1), or plans to initiate, terminate, or change any outpatient psychotherapy during the course of the study.

• ECT within 1 month of Screening (Visit 1).

• Participant is unwilling to discontinue or, in the opinion of the investigator, unable to safely taper off any protocol-specified prohibited treatment prior to the Baseline (Visit 2) without significant destabilization or increased suicidality.

• Participant is currently enrolled in another investigational drug or device study or participation in such a study within 3 months of Baseline (Visit 2).

• Known history of human immunodeficiency virus infection.

• Female participant who entered menarche and is sexually active, and with any of the following at Screening (Visit 1): positive pregnancy test, nursing, or planning to become pregnant at any time during participation in the study.

• Known allergy or sensitivity to the study intervention or its components.

• History of serious homicidal risk or behavior that resulted in hospitalization or adjudication (legal sentencing) within 6 months of Screening (Visit 1).

• History of suicide attempt within 6 months of Screening (Visit 1) in the judgment of the investigator.

• The participant has a condition or is in a situation, which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study.

• Current suicidal or homicidal ideation in the judgment of the investigator.