One-Year Open-Label Study of Iloperidone Tablets in Adolescents Aged 12 to 17 With Schizophrenia or Bipolar I Disorder

What this Trial Is About

This research aims to evaluate the safety and tolerability of iloperidone in adolescents diagnosed with schizophrenia or bipolar I disorder. The study focuses on treatment effects over a period of up to 52 weeks and is sponsored by Vanda Pharmaceuticals. It is a phase 4 open-label trial designed to assess how well adolescent patients tolerate iloperidone treatment. Participants will receive iloperidone in oral tablet form, with doses ranging from 8 to 24 mg per day. The treatment period lasts for one year, during which patients are monitored closely. This open-label study means both participants and researchers know the treatment being administered, with no placebo group. Throughout the study, patients will be regularly assessed for treatment-emergent adverse events and other safety measures. Researchers will track any side effects or reactions to iloperidone over the treatment period. Participation involves completing study visits and assessments for up to 52 weeks, ensuring ongoing monitoring of safety and tolerability.

Safety and Tolerability of Open-Labeled Iloperidone in Adolescents