Evaluating the safety of iloperidone in adolescents with schizophrenia or bipolar disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study assesses the safety and tolerability of iloperidone, an antipsychotic medication, in adolescents aged 12 to 17 diagnosed with schizophrenia or bipolar I disorder. Participants will receive open-label treatment with iloperidone for up to 52 weeks, allowing researchers to monitor side effects and overall tolerability. The study aims to gather important data on how this medication affects younger patients, which is crucial for understanding its use in this age group.

Why it matters

Who can join: the full rules

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

Where it's running

• Vanda Investigational Site
  Dothan, Alabama, United States Recruiting
• Vanda Investigational Site
  Little Rock, Arkansas, United States Recruiting
• Vanda Investigational Site
  Denver, Colorado, United States Recruiting
• Vanda Investigational Site
  Atlanta, Georgia, United States Recruiting
• Vanda Investigational Site
  Atlanta, Georgia, United States Recruiting
• Vanda Investigational Site
  Decatur, Georgia, United States Recruiting

Study contacts

• Study coordinator: Vanda Pharmaceuticals Inc.
• Email: clinicaltrials@vandapharma.com
• Phone: 202-734-3400

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.