Study detail
RecruitingPhase 4
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
Vanda Pharmaceuticals
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
- Age range
- 12–17 years
- Sex
- All
- Healthy volunteers
- No
Detailed criteria
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
- DrugIloperidone
oral tablet
Locations (9)
- Vanda Investigational SiteLittle Rock, Arkansas
- Vanda Investigational SiteDenver, Colorado
- Vanda Investigational SiteAtlanta, Georgia
- Vanda Investigational SiteAtlanta, Georgia
- Vanda Investigational SiteDecatur, Georgia
- Vanda Investigational SiteCincinnati, Ohio