NCT00254202

Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia

A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Iloperidone in Schizophrenic Patients in Acute Exacerbation Followed by a Long-term Treatment Phase.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 593 (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 the safety and efficacy of iloperidone compared to placebo and an active comparator in the treatment of patients with schizophrenia in acute exacerbation.

Detailed description

Schizophrenia is a severe mental illness affecting an estimated 1% of the world's population. Patients with schizophrenia suffer from productive symptoms (e.g., hallucinations and delusions), and deficit symptoms (e.g., a reduction or absence of normal behaviors or emotions). Other symptoms include a reduced ability to recall and learn new information. Iloperidone is being development as a treatment for symptoms of schizophrenia. This trial will test the safety and efficacy of iloperidone in patients with an acute exacerbation of the disease.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Iloperidone
DRUG	Ziprasidone
DRUG	Placebo

Timeline

• Start date: 2005-11-18
• Primary completion: 2006-09-26
• Completion: 2007-03-21
• First posted: 2005-11-15
• Last updated: 2024-12-13
• Results posted: 2024-12-13

Locations

42 sites across 2 countries: United States, India

Regulatory

• FDA-regulated drug study