Iloperidone Safety for Adolescent Schizophrenia
Recruiting at 12 trial locations
VP
Overseen ByVanda Pharmaceuticals Inc.
Age: < 18
Sex: Any
Trial Phase: Phase 4
Sponsor: Vanda Pharmaceuticals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
What You Need to Know Before You Apply
What is the purpose of this trial?
To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.
Are You a Good Fit for This Trial?
This trial is for adolescents aged 12-17 with a clinical diagnosis of schizophrenia or bipolar I disorder. Participants must be willing to complete the study and have parental consent. Those using drugs of abuse or other investigational drugs recently cannot join.Inclusion Criteria
I am between 12 and 17 years old.
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
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Exclusion Criteria
You cannot participate if you have taken any experimental drugs within the last 30 days or 5 half-lives before starting this study.
A positive test for drugs of abuse
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive open-label iloperidone for up to 52 weeks
52 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
What Are the Treatments Tested in This Trial?
Interventions
- Iloperidone
Trial Overview The trial is testing the safety and how well patients can tolerate iloperidone, a medication intended for schizophrenia or bipolar I disorder in adolescents, over a period of up to one year.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: IloperidoneExperimental Treatment1 Intervention
Open-label iloperidone
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanda Pharmaceuticals
Lead Sponsor
Trials
68
Recruited
19,900+
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