NCT01291511

Relapse Prevention Study in Patients With Schizophrenia

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate Prevention of Relapse in Patients With Schizophrenia Receiving Either Flexible Dose Iloperidone or Placebo in Long-term Use (up to 26 Weeks) Followed by up to 52 Weeks of Open-label Extension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 635 (actual)
• Sponsor: Vanda Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether Iloperidone is effective in the prevention of relapse in patients with schizophrenia

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Iloperidone	Over-encapsulated iloperidone tablets were administered orally using a bid schedule; the strengths used include 1, 2, 4, 6, 8, 10, and 12 mg.
DRUG	Placebo	Matching placebo capsules were administered orally using a bid schedule during the double-blind period.

Timeline

• Start date: 2011-02-01
• Primary completion: 2014-03-01
• Completion: 2015-03-01
• First posted: 2011-02-08
• Last updated: 2023-07-17
• Results posted: 2023-07-17

Locations

63 sites across 3 countries: United States, India, Ukraine

Regulatory

• FDA-regulated drug study