Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanda Pharmaceuticals
• Treatments: Iloperidone

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