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Clinical Trials in the USA / NCT05648591
Recruiting Phase 4

Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

NCT05648591 · tracked via the Priya Life Science USA tracker
Sponsor
Vanda Pharmaceuticals
Phase
Phase 4
Started
2023-05-24
Last updated
2026-10-01

Condition(s) studied

SchizophreniaBipolar I Disorder

Investigational drug(s) / intervention(s)

Iloperidone →

Iloperidone: oral tablet

Study summary

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

Eligibility

Sex
ALL
Min age
12 Years
Max age
17 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period. — 1 year

Trial sites (11)

FacilityCityRegionStatus
Vanda Investigational Site Dothan Alabama Recruiting
Vanda Investigational Site Little Rock Arkansas Recruiting
Vanda Investigational Site Denver Colorado Recruiting
Vanda Investigational Site Atlanta Georgia Recruiting
Vanda Investigational Site Atlanta Georgia Recruiting
Vanda Investigational Site Decatur Georgia Recruiting
Vanda Investigational Site Kinston North Carolina Recruiting
Vanda Investigational Site Cincinnati Ohio Recruiting
Vanda Investigational Site Garfield Heights Ohio Recruiting
Vanda Investigational Site Westlake Ohio Recruiting
Vanda Investigational Site Everett Washington Recruiting

More Vanda Pharmaceuticals trials in the USA

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Patient Registry of Blind Subjects With Sleep-related Problems Recruiting
ODYSSEY: A Study to Investigate the Efficacy of Tradipitant in Treating Severe or Critical COVID-19 Infection Enrolling by invitation
Motion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness Active, not recruiting
Randomized Withdrawal Study in Patients With Schizophrenia Recruiting

Other trials for the same condition

Study of SPG302 in Adults With Schizophrenia Active, not recruiting
Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects Enrolling by invitation
A Study to Evaluate the Safety, Tolerability, and PK of an Injectable Form of KarXT Recruiting
Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT) Recruiting
Zyprexa® Relprevv™ Patient Care Program Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05648591 on ClinicalTrials.gov ↗ ← All trials in the USA