Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

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.

Conditions

Schizophrenia, Bipolar I Disorder

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Study Overview

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Study Details

Study overview

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

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

Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

Condition
Schizophrenia
Intervention / Treatment

-

Contacts and Locations

Miami

Vanda Investigational Site, Miami, Florida, United States, 33173

W. Miami

Vanda Investigational Site, W. Miami, Florida, United States, 33144

Atlanta

Vanda Investigational Site, Atlanta, Georgia, United States, 30318

Atlanta

Vanda Investigational Site, Atlanta, Georgia, United States, 30331

Decatur

Vanda Investigational Site, Decatur, Georgia, United States, 30030

Saint Louis

Vanda Investigational Site, Saint Louis, Missouri, United States, 63128

Cincinnati

Vanda Investigational Site, Cincinnati, Ohio, United States, 45221

Garfield Heights

Vanda Investigational Site, Garfield Heights, Ohio, United States, 44125

Westlake

Vanda Investigational Site, Westlake, Ohio, United States, 44145

DeSoto

Vanda Investigational Site, DeSoto, Texas, United States, 75115

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

12 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vanda Pharmaceuticals,

Study Record Dates

2024-09