Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

NCT ID: NCT05648591

Last Updated: 2025-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-24

Study Completion Date

2026-11-30

Brief Summary

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

Detailed Description

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Conditions

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Schizophrenia Bipolar I Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Iloperidone

Open-label iloperidone

Group Type EXPERIMENTAL

Iloperidone

Intervention Type DRUG

oral tablet

Interventions

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Iloperidone

oral tablet

Intervention Type DRUG

Other Intervention Names

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VYV-683 FANAPT

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanda Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vanda Investigational Site

Little Rock, Arkansas, United States

Site Status RECRUITING

Vanda Investigational Site

Denver, Colorado, United States

Site Status RECRUITING

Vanda Investigational Site

Atlanta, Georgia, United States

Site Status RECRUITING

Vanda Investigational Site

Atlanta, Georgia, United States

Site Status RECRUITING

Vanda Investigational Site

Decatur, Georgia, United States

Site Status RECRUITING

Vanda Investigational Site

Cincinnati, Ohio, United States

Site Status RECRUITING

Vanda Investigational Site

Garfield Heights, Ohio, United States

Site Status RECRUITING

Vanda Investigational Site

Westlake, Ohio, United States

Site Status NOT_YET_RECRUITING

Vanda Investigational Site

Everett, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Vanda Pharmaceuticals Inc.

Role: CONTACT

202-734-3400

Facility Contacts

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Role: primary

202-734-3400

Role: primary

202-734-3400

Role: primary

202-734-3400

Role: primary

202-734-3400

Role: primary

202-734-3400

Vanda Pharmaceuticals

Role: primary

202-734-3400

Role: primary

202-734-3400

Role: primary

202-734-3400

Role: primary

202-734-3400

Other Identifiers

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VP-VYV-683-4101

Identifier Type: -

Identifier Source: org_study_id

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