Checks safety of iloperidone in teens with schizophrenia or bipolar disorder
Tests how safe iloperidone is for teenagers with schizophrenia or bipolar I disorder.
Plain-language title generated from the registry record
Registry title: Safety and Tolerability of Open-Labeled Iloperidone in Adolescents
Key facts
- Where
- Atlanta, Cincinnati, Decatur, Denver, Dothan, Everett, Garfield Heights, Kinston, Little Rock, and Westlake, United StatesSee the 10 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 17 years old?
Source: NCT05648591, who can take part
Where in United States
- AtlantaAtlanta, United StatesTaking people
- CincinnatiCincinnati, United StatesTaking people
- DecaturDecatur, United StatesTaking people
- DenverDenver, United StatesTaking people
- DothanDothan, United StatesTaking people
- EverettEverett, United StatesTaking people
- Garfield HeightsGarfield Heights, United StatesTaking people
- KinstonKinston, United StatesTaking people
- Little RockLittle Rock, United StatesTaking people
- WestlakeWestlake, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vanda Pharmaceuticals
- Trial code
- NCT05648591
- Record updated
- 1 October 2026
- Original description
To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.Read full original descriptionShow less
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
To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.
Inclusion: 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: 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.