Iloperidone for Schizophrenia or Bipolar I Disorder in Adolescents

This study is looking at the safety of a medicine called iloperidone for teenagers aged 12 to 17 who have schizophrenia or bipolar I disorder. Researchers want to see how many participants experience side effects while taking iloperidone for up to one year. You could join if you are 12-17 years old, have been diagnosed with schizophrenia or bipolar I disorder, and are willing to participate. Your parent or guardian would also need to agree. The study plans to enroll 100 participants. The current recruitment status is unclear.

Study design
This is an open-label study, meaning everyone knows they are receiving iloperidone. It plans to enroll 100 participants aged 12-17.
What's involved
You would take iloperidone as an oral tablet for up to 52 weeks. Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will track side effects for one year after treatment begins.

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NCT05648591

Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

Recruiting
PHASE4Ages 12–17InterventionalTreatment
Vanda Pharmaceuticals
~100 participants
Updated 2025-03-04 on ClinicalTrials.gov
What's tested:Iloperidone

At a glance

Recruiting sites
8 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period.
Measured over 1 year
Schizophrenia
Bipolar I Disorder
9 sites across 5 states
Georgia3
Ohio3
Arkansas1
Colorado1
Washington1

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Eligibility criteria

Inclusion

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

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
  • Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period.1 year