Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

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

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Key information

Conditions

Schizophrenia Bipolar I Disorder Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vanda Investigational Site, Little Rock, Arkansas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iloperidone

Drug

oral tablet

Other names: VYV-683, FANAPT

Primary outcomes

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

Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Vanda Pharmaceuticals Inc.

CONTACT

[email protected]

202-734-3400

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Dec 13, 2022
Registry last updated: Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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