Evaluating the safety of iloperidone in adolescents with schizophrenia or bipolar disorder
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
This study is testing how safe the medication iloperidone is for teenagers aged 12 to 17 who have schizophrenia or bipolar disorder.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | Vanda Pharmaceuticals Industry-sponsored |
| Locations | 9 sites (Little Rock, Arkansas and 8 other locations) |
| Trial ID | NCT05648591 on ClinicalTrials.gov |
What this trial studies
This study assesses the safety and tolerability of iloperidone, an antipsychotic medication, in adolescents aged 12 to 17 diagnosed with schizophrenia or bipolar I disorder. Participants will receive open-label treatment with iloperidone for up to 52 weeks, allowing researchers to monitor side effects and overall tolerability. The study aims to gather important data on how this medication affects younger patients, which is crucial for understanding its use in this age group.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents aged 12 to 17 who have a clinical diagnosis of schizophrenia or bipolar I disorder.
Not a fit: Patients who are currently using other investigational drugs or have a positive drug test may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safe use of iloperidone for treating adolescents with serious mental health conditions.
How similar studies have performed: While studies on iloperidone have been conducted in adults, this specific focus on adolescents is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Little Rock, Arkansas and 8 other locations
- Vanda Investigational Site — Little Rock, Arkansas, United States (Recruiting)
- Vanda Investigational Site — Denver, Colorado, United States (Recruiting)
- Vanda Investigational Site — Atlanta, Georgia, United States (Recruiting)
- Vanda Investigational Site — Atlanta, Georgia, United States (Recruiting)
- Vanda Investigational Site — Decatur, Georgia, United States (Recruiting)
- Vanda Investigational Site — Cincinnati, Ohio, United States (Recruiting)
- Vanda Investigational Site — Garfield Heights, Ohio, United States (Recruiting)
- Vanda Investigational Site — Westlake, Ohio, United States (Not_yet_recruiting)
- Vanda Investigational Site — Everett, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Vanda Pharmaceuticals Inc.
- Email: clinicaltrials@vandapharma.com
- Phone: 202-734-3400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.