Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

Launched by VANDA PHARMACEUTICALS · Dec 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called iloperidone to see how safe it is and how well it can be tolerated by adolescents aged 12 to 17 who have schizophrenia or bipolar I disorder. The study will last for up to 52 weeks, and researchers want to understand how the medication affects young patients during this time.

To be eligible to participate, young people must be willing to take part in the study and get permission from a parent or guardian. They should not be taking any other experimental drugs or have tested positive for substance abuse. If your child qualifies and decides to join, they will receive iloperidone and be closely monitored by the medical team to ensure their safety throughout the trial. This is a great opportunity to help advance our understanding of treatment options for these conditions in adolescents.

Gender

ALL

Eligibility criteria

• 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