Safety and Tolerability of Open-Labeled Iloperidone in Adolescents

Phase 4

Recruiting

• Conditions: Schizophrenia; Bipolar I Disorder
• Interventions: Drug: Iloperidone

• Registration Number: NCT05648591
• Lead Sponsor: Vanda Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-05
• Study First Submitted QC: 2022-12-05
• Study First Posted: 2022-12-13
• Study Start: 2023-05-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-04
• Primary Completion: 2026-03-31
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iloperidone	Iloperidone	Open-label iloperidone

Primary Outcome Measures

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

Trial Locations

Locations (1)

Vanda Investigational Site; 🇺🇸 Everett, Washington, United States