Iloperidone Safety for Adolescent Schizophrenia

Recruiting at 12 trial locations

Overseen By Vanda Pharmaceuticals Inc.

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Vanda Pharmaceuticals

Must not be taking: Investigational drugs, Drugs of abuse

Disqualifiers: Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

100 Participants Needed

Trial Summary

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.

Eligibility Criteria

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

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

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

Treatment Details

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.

Participant Groups

Group I: Iloperidone Experimental Treatment 1 Intervention

Open-label iloperidone

Who Is Running the Clinical Trial?

Vanda Pharmaceuticals

Lead Sponsor

Trials

68

Recruited

19,900+