RECRUITINGPhase 4INTERVENTIONAL
Safety and Tolerability of Open-Labeled Iloperidone in Adolescents
Open-label Safety Study of a 1-year 8 to 24 mg/Day Dose Regimen of Iloperidone (FANAPT®) in Adolescent Patients With Schizophrenia or Bipolar I Disorder
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Iloperidone
oral tablet
Locations (9)
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