Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

Last updated: February 27, 2025
Sponsor: Vanda Pharmaceuticals
Overall Status: Active - Recruiting

Phase

4

Condition

Mood Disorders

Psychosis

Schizotypal Personality Disorder (Spd)

Treatment

Iloperidone

Clinical Study ID

NCT05648591
VP-VYV-683-4101
  • Ages 12-17
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Patient is willing and able to provide assent and willing to complete all aspects ofthe 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

Exclusion Criteria:

  • Use of other investigational drugs at the time of enrollment, or within 30 days or 5half-lives of enrollment, whichever is longer

  • A positive test for drugs of abuse

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Iloperidone
Phase: 4
Study Start date:
May 24, 2023
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • Vanda Investigational Site

    Little Rock, Arkansas 72204
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Denver, Colorado 80202
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Miami, Florida 33173
    United States

    Site Not Available

  • Vanda Investigational Site

    W. Miami, Florida 33144
    United States

    Site Not Available

  • Vanda Investigational Site

    Atlanta, Georgia 30331
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • Vanda Investigational Site

    Cincinnati, Ohio 45221
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Garfield Heights, Ohio 44125
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Westlake, Ohio 44145
    United States

    Site Not Available

  • Vanda Investigational Site

    DeSoto, Texas 75115
    United States

    Site Not Available

  • Vanda Investigational Site

    Everett, Washington 98201
    United States

    Active - Recruiting

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