Recruiting NCT05648591
Safety and Tolerability of Open-Labeled Iloperidone in Adolescents
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Iloperidone.
- Who it may be relevant to
- Registry conditions: Schizophrenia, Bipolar I Disorder. Basic parameters: 12 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.
Interventions
- Drug Iloperidone
oral tablet
Primary outcome measures
- Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period. [Time frame: 1 year]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 9 centers
- Vanda Investigational Site — Little Rock
- Vanda Investigational Site — Denver
- Vanda Investigational Site — Atlanta
- Vanda Investigational Site — Atlanta
- Vanda Investigational Site — Decatur
- Vanda Investigational Site — Cincinnati
- Vanda Investigational Site — Garfield Heights
- Vanda Investigational Site — Westlake
- … and 1 more center
Identifiers
NCT: NCT05648591 · VP-VYV-683-4101