RightFit
RecruitingPhase 4

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

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 52 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe iloperidone is and how well teens can handle its side effects during up to 52 weeks of treatment. It is for teens ages 12 to 17 with schizophrenia or bipolar I disorder.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 12 to 17 years old.
  • You have been diagnosed with schizophrenia, a condition that affects thoughts and sense of reality, or bipolar I disorder, which causes major changes in mood and energy.
  • You are willing and able to agree to join and willing to complete all parts of the study.
  • Your parent or legal guardian is willing and able to give permission.

Who can't join

  • You use another study drug when you join, or used one within the longer of these times: 30 days or the time it takes the drug's amount in your body to drop by half five times.
  • You test positive for drugs of abuse.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (11)

AL

AR

CO

GA

NC

OH

WA