RecruitingPhase 4NCT05648591
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
Sponsor
Vanda Pharmaceuticals
Enrollment
100 participants
Start Date
May 24, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 12 YearsMax Age: 17 Years
Inclusion Criteria4
- 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 Criteria2
- 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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05648591
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