Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

February 27, 2025 updated by: Vanda Pharmaceuticals

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Phone Number: 202-734-3400
    • Colorado
      • Denver, Colorado, United States, 80202
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Phone Number: 202-734-3400
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Phone Number: 202-734-3400
      • Atlanta, Georgia, United States, 30318
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Phone Number: 202-734-3400
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Phone Number: 202-734-3400
    • Ohio
      • Cincinnati, Ohio, United States, 45221
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals
          • Phone Number: 202-734-3400
      • Garfield Heights, Ohio, United States, 44125
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Phone Number: 202-734-3400
      • Westlake, Ohio, United States, 44145
        • Not yet recruiting
        • Vanda Investigational Site
        • Contact:
          • Phone Number: 202-734-3400
    • Washington
      • Everett, Washington, United States, 98201
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Phone Number: 202-734-3400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 13 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iloperidone
Open-label iloperidone
Drug: Iloperidone
oral tablet
Other Names:
  • VYV-683
  • FANAPT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanda Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2023

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

December 5, 2022

First Submitted That Met QC Criteria

December 5, 2022

First Posted (Actual)

December 13, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-VYV-683-4101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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