RECRUITING

Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

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Conditions

SchizophreniaBipolar I Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official 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

Quick Facts

Study Start:2023-05-24
Study Completion:2024-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05648591

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.

Ages Eligible for Study:12 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Patient is willing and able to provide assent and willing to complete all aspects of the study
  2. * Patient's parent or legal guardian willing and able to provide consent
  3. * Male or female patients 12 through 17 years of age (inclusive)
  4. * Clinical diagnosis of either schizophrenia or bipolar I disorder
  1. * Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
  2. * A positive test for drugs of abuse

Contacts and Locations

Study Contact

Vanda Pharmaceuticals Inc.
CONTACT
202-734-3400
clinicaltrials@vandapharma.com

Study Locations (Sites)

Vanda Investigational Site
Miami, Florida, 33173
United States
Vanda Investigational Site
W. Miami, Florida, 33144
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
Saint Louis, Missouri, 63128
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
DeSoto, Texas, 75115
United States
Vanda Investigational Site
Everett, Washington, 98201
United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2023-05-24
Study Completion Date2024-09

Study Record Updates

Study Start Date2023-05-24
Study Completion Date2024-09

Terms related to this study

Additional Relevant MeSH Terms

  • Schizophrenia
  • Bipolar I Disorder