The trial is taking place at:
A

Advanced Research Institute of Miami | Homestead, FL

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

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Status and phase

Enrolling
Phase 3

Conditions

Bipolar I Disorder
Schizophrenia
Autism Spectrum Disorder (ASD)

Treatments

Drug: Cariprazine Flexible Dose

Study type

Interventional

Funder types

Industry

Identifiers

NCT04578756
3070-301-001

Details and patient eligibility

About

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

Enrollment

280 estimated patients

Sex

All

Ages

5 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* Participants with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia or bipolar I disorder, or autism spectrum disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL) at the Screening Visit 1 (for de novo subjects, or as previously confirmed in parent study for subjects who completed Study 3112-301-001 or M21-465). * De novo participants must have normal physical examination findings, clinical laboratory test results, and electrocardiogram (ECG) results at Screening Visit 1. Abnormal results must not be clinically significant as determined by the investigator. Participants enrolling after completion of Study M21-465 or 3112-301-001 have had monitoring of laboratory tests, physical examinations, ocular assessments, and ECGs, of which the results enabled ongoing trial participation. As such, eligibility for participants enrolling from these parent studies need not be contingent on results of these tests but participants must be withdrawn if results of these tests meet withdrawal criteria. * 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.

Exclusion criteria

* Participants with DSM-5-TR diagnosis of major depressive disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition. Participants with ASD that is associated with Rett disorder, fragile-X syndrome, or childhood disintegrative disorder. * Prior DSM-5-TR diagnosis of intellectual disability (IQ \< 70) for schizophrenia and bipolar I disorder participants. Prior DSM-5-TR diagnosis of profound intellectual disability (IQ \< 25) for ASD participants. * 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

280 participants in 11 patient groups

Cariprazine Dose 1
Experimental group
Description:
Participants with Schizophrenia (age 13 to 17 years and < 40 kg body weight) will receive cariprazine.
Treatment:
Drug: Cariprazine Flexible Dose
Cariprazine Dose 2
Experimental group
Description:
Participants with Schizophrenia (age 13 to 17 years and >= 40 kg body weight) will receive cariprazine.
Treatment:
Drug: Cariprazine Flexible Dose
Cariprazine Dose 3
Experimental group
Description:
Participants with Bipolar I Disorder (age 10 to 12 years and <40 kg body weight) will receive cariprazine.
Treatment:
Drug: Cariprazine Flexible Dose
Cariprazine Dose 4
Experimental group
Description:
Participants with Bipolar I Disorder (age 10 to 12 years and >= 40 kg body weight) will receive cariprazine.
Treatment:
Drug: Cariprazine Flexible Dose
Cariprazine Dose 5
Experimental group
Description:
Participants with Bipolar I Disorder (age 13 to 17 years and < 40 kg body weight) will receive cariprazine.
Treatment:
Drug: Cariprazine Flexible Dose
Cariprazine Dose 6
Experimental group
Description:
Participants with Bipolar I Disorder (age 13 to 17 years and >= 40 kg body weight) will receive cariprazine.
Treatment:
Drug: Cariprazine Flexible Dose
Cariprazine Dose 7
Experimental group
Description:
Participants with Autism Spectrum Disorder ( age 5 to 9 years) will receive cariprazine.
Treatment:
Drug: Cariprazine Flexible Dose
Cariprazine Dose 8
Experimental group
Description:
Participants with Autism Spectrum Disorder (age 10 to 12 years and <40 kg weight) will receive cariprazine.
Treatment:
Drug: Cariprazine Flexible Dose
Cariprazine Dose 9
Experimental group
Description:
Participants with Autism Spectrum Disorder (age 10 to 12 years and >=40 kg body weight) will receive cariprazine.
Treatment:
Drug: Cariprazine Flexible Dose
Cariprazine Dose 10
Experimental group
Description:
Participants with Autism Spectrum Disorder (age 13 to 17 years and <40 kg weight) will receive cariprazine.
Treatment:
Drug: Cariprazine Flexible Dose
Cariprazine Dose 11
Experimental group
Description:
Participants with Autism Spectrum Disorder (age 13 to 17 years and >= 40 kg body weight) will receive cariprazine.
Treatment:
Drug: Cariprazine Flexible Dose

Trial contacts and locations

40

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Central trial contact

ABBVIE CALL CENTER

Data sourced from clinicaltrials.gov

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