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

Conditions

• Autism Spectrum Disorder (ASD)
• Bipolar I Disorder
• Schizophrenia

Eligibility Criteria

Sex

ALL

Age

5 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Cariprazine Flexible Dose — DRUG
  1 capsule to be taken orally at approximately the same time of day (morning or evening)
• Cariprazine Flexible Dose — DRUG
  Dose solution (in milliliters) to be taken orally at approximately the same time of day (morning or evening)

Study Details

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.

Key Dates

Start date

Feb 1, 2021

Status verified

Oct 2025

Primary completion

Oct 6, 2025

Completion

Oct 6, 2025

Study Design

Enrollment

310 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events (TEAEs) in the Treatment Period [ Time Frame: Baseline Day 1 to Week 59 ]

Locations (40)

Find similar trials in Dothan, AL

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