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NCT05648591PHASE4Recruiting

Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

Vanda Pharmaceuticals

Start Date

5/24/2023

Completion Date

11/30/2026

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 Criteria

Age Range: 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

Interventions

DRUG

Iloperidone

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Conditions

SchizophreniaBipolar I Disorder

Locations

Vanda Investigational Site

Little Rock, Arkansas 72204

United States

Vanda Investigational Site

Denver, Colorado 80202

United States

Vanda Investigational Site

Atlanta, Georgia 30318

United States

Vanda Investigational Site

Atlanta, Georgia 30331

United States

Vanda Investigational Site

Decatur, Georgia 30030

United States

Vanda Investigational Site

Cincinnati, Ohio 45221

United States

Vanda Investigational Site

Garfield Heights, Ohio 44125

United States

Vanda Investigational Site

Westlake, Ohio 44145

United States

Vanda Investigational Site

Everett, Washington 98201

United States