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

AbbVie

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: 325 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, and ECGs at the completion visit of the parent studies.
• 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.
• 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)

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325 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

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

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

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

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

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

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

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

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

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

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

Drug: Cariprazine Flexible Dose