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Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

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

Who can join

Ages 12 to 17 · All sexes

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

About the study

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

What is being tested

• Iloperidone (drug)

Sponsor: Vanda Pharmaceuticals · Participants: 100 · Started: May 24, 2023

Contact the study team

• Vanda Pharmaceuticals Inc. · Phone: 202-734-3400

Official record on ClinicalTrials.gov — NCT05648591

Locations in the U.S.

Conditions

• Schizophrenia

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.