NCT05648591RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 5 Dec 2022
- Start date
- May 2023
- Primary completion date
- Dec 2028
- Lead sponsor
- Vanda Pharmaceuticals
- Diseases
- Schizophrenia, Bipolar disorder
- NCT number
- NCT05648591
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- From May 2023 to the primary completion date, Dec 2028
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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
Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Decatur | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Dothan | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Everett | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Garfield Heights | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Kinston | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Westlake | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.