Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

Open-label Safety Study of a 1-year 8 to 24 mg/Day Dose Regimen of Iloperidone (FANAPT®) in Adolescent Patients With Schizophrenia or Bipolar I Disorder

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

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