NCT05648591

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Vanda Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia
• Bipolar I Disorder

Interventions

Type	Name	Description
DRUG	Iloperidone	oral tablet

Timeline

• Start date: 2023-05-24
• Primary completion: 2026-03-31
• Completion: 2026-11-30
• First posted: 2022-12-13
• Last updated: 2025-03-04

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study