RecruitingPhase 4NCT05648591

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


Sponsor

Vanda Pharmaceuticals

Enrollment

100 participants

Start Date

May 24, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 12 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study tests the safety and tolerability of a medication called iloperidone in teenagers diagnosed with schizophrenia or another condition called schizoaffective disorder. Iloperidone is already approved for adults but needs more study in younger patients. **You may be eligible if...** - You are between 12 and 17 years old - You have been diagnosed with schizophrenia or schizoaffective disorder - Your parent or guardian can provide consent **You may NOT be eligible if...** - You have significant heart problems or a family history of serious heart conditions - You have certain other medical conditions that make this medication unsafe - You are taking medications that could interact with iloperidone Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIloperidone

oral tablet


Locations(9)

Vanda Investigational Site

Little Rock, Arkansas, United States

Vanda Investigational Site

Denver, Colorado, United States

Vanda Investigational Site

Atlanta, Georgia, United States

Vanda Investigational Site

Atlanta, Georgia, United States

Vanda Investigational Site

Decatur, Georgia, United States

Vanda Investigational Site

Cincinnati, Ohio, United States

Vanda Investigational Site

Garfield Heights, Ohio, United States

Vanda Investigational Site

Westlake, Ohio, United States

Vanda Investigational Site

Everett, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT05648591


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