Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

Recruiting now · Phase 4

Conditions studied: Schizophrenia, Bipolar I Disorder

In brief

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

Key facts

Study ID

NCT05648591

Run by

Vanda Pharmaceuticals

People needed

100

Starts

2023-05-24

Expected to finish

2026-11-30

Last updated by the study team

2025-03-04

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Vanda Investigational Site — Everett, Washington, United States (enrolling)
• Vanda Investigational Site — Denver, Colorado, United States (enrolling)
• Vanda Investigational Site — Atlanta, Georgia, United States (enrolling)
• Vanda Investigational Site — Atlanta, Georgia, United States (enrolling)
• Vanda Investigational Site — Decatur, Georgia, United States (enrolling)
• Vanda Investigational Site — Cincinnati, Ohio, United States (enrolling)
• Vanda Investigational Site — Garfield Heights, Ohio, United States (enrolling)
• Vanda Investigational Site — Little Rock, Arkansas, United States (enrolling)
• Vanda Investigational Site — Westlake, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.