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Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

Recruiting
12-17 years
All
Phase 4

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Overview

To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.

Eligibility

Inclusion Criteria:

  • Patient is willing and able to provide assent and willing to complete all aspects of the study
  • Patient's parent or legal guardian willing and able to provide consent
  • Male or female patients 12 through 17 years of age (inclusive)
  • Clinical diagnosis of either schizophrenia or bipolar I disorder

Exclusion Criteria:

  • Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
  • A positive test for drugs of abuse

Study details
    Schizophrenia
    Bipolar I Disorder

NCT05648591

Vanda Pharmaceuticals

28 January 2024

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