Open-label Safety Study of a 1-year 8 to 24 mg/Day Dose Regimen of Iloperidone (FANAPTĀ®) in Adolescent Patients With Schizophrenia or Bipolar I Disorder
| Registry | NCT05648591 |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 100 (Estimated) |
| Sponsor | Vanda Pharmaceuticals (Industry) |
| Conditions | Schizophrenia, Bipolar I Disorder |
| Interventions | Iloperidone (Drug) |
| Dates | start 2023-05-24, primary completion 2028-12-31 (estimated), completion 2028-12-31 (estimated), first posted 2022-12-13, last updated 2026-10-01 |
| Locations | 11 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Schizophrenia All trials for Bipolar I Disorder All trials of Iloperidone
To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Iloperidone | Experimental | Drug: Iloperidone | Open-label iloperidone |
Sex: All, ages: 12 Years to 17 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Vanda Investigational Site | Dothan, Alabama | United States | Recruiting |
| 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 | Kinston, North Carolina | 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 | Recruiting |
| Vanda Investigational Site | Everett, Washington | United States | Recruiting |