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Recruiting Phase 4 Interventional

Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

ClinicalTrials.gov ID: NCT05648591

Public ClinicalTrials.gov record NCT05648591. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 4:54 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.

Study identification

NCT ID
NCT05648591
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 4
Lead sponsor
Vanda Pharmaceuticals
Industry
Enrollment
100 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
12 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 24, 2023 (Actual)
Primary completion
Dec 31, 2028 (Estimated)
Completion
Dec 31, 2028 (Estimated)
Last update posted
Oct 1, 2026

2023 – 2028

United States locations

U.S. sites
11
U.S. states
7
U.S. cities
10
Facility City State ZIP Site status
Vanda Investigational Site Dothan Alabama 36303 Recruiting
Vanda Investigational Site Little Rock Arkansas 72204 Recruiting
Vanda Investigational Site Denver Colorado 80202 Recruiting
Vanda Investigational Site Atlanta Georgia 30318 Recruiting
Vanda Investigational Site Atlanta Georgia 30331 Recruiting
Vanda Investigational Site Decatur Georgia 30030 Recruiting
Vanda Investigational Site Kinston North Carolina 28501 Recruiting
Vanda Investigational Site Cincinnati Ohio 45221 Recruiting
Vanda Investigational Site Garfield Heights Ohio 44125 Recruiting
Vanda Investigational Site Westlake Ohio 44145 Recruiting
Vanda Investigational Site Everett Washington 98201 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05648591, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 1, 2026 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05648591 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →