NCT05648591PHASE4Recruiting
Safety and Tolerability of Open-Labeled Iloperidone in Adolescents
Vanda Pharmaceuticals
Start Date
5/24/2023
Completion Date
11/30/2026
Summary
To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.
Eligibility Criteria
Age Range: 12 years to 17 years
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
Interventions
DRUG
Iloperidone
Conditions
SchizophreniaBipolar I Disorder
Locations
Vanda Investigational Site
Little Rock, Arkansas 72204
United States
Vanda Investigational Site
Denver, Colorado 80202
United States
Vanda Investigational Site
Atlanta, Georgia 30318
United States
Vanda Investigational Site
Atlanta, Georgia 30331
United States
Vanda Investigational Site
Decatur, Georgia 30030
United States
Vanda Investigational Site
Cincinnati, Ohio 45221
United States
Vanda Investigational Site
Garfield Heights, Ohio 44125
United States
Vanda Investigational Site
Westlake, Ohio 44145
United States
Vanda Investigational Site
Everett, Washington 98201
United States