Safety and Tolerability of Open-Labeled Iloperidone in Adolescents
Recruiting · NCT05648591 · Interventional (participants receive a specific treatment) · Lead sponsor: Vanda Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.
Who can take part
Age range
12 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific 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
Where it is running
9 locations listed across 5 US states.
- Vanda Investigational Site - Little Rock, Arkansas, United States
- Vanda Investigational Site - Denver, Colorado, United States
- Vanda Investigational Site - Atlanta, Georgia, United States
- Vanda Investigational Site - Atlanta, Georgia, United States
- Vanda Investigational Site - Decatur, Georgia, United States
- Vanda Investigational Site - Cincinnati, Ohio, United States
- Vanda Investigational Site - Garfield Heights, Ohio, United States
- Vanda Investigational Site - Westlake, Ohio, United States
- Vanda Investigational Site - Everett, Washington, United States