Status:

COMPLETED

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

Lead Sponsor:

Vanda Pharmaceuticals

Conditions:

Schizophrenia

Eligibility:

All Genders

18-65 years

Phase:

PHASE3

Brief 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 defi...

Eligibility Criteria

Inclusion

  • DSM-IV diagnosis of schizophrenia
  • PANSS-T of at least 70 at screening and baseline

Exclusion

  • Clinically significant disease of the heart, kidneys, liver or gastrointestinal system
  • DSM-IV diagnosis of psychiatric disorder other than schizophrenia

Key Trial Info

Start Date :

November 18 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 21 2007

Estimated Enrollment :

593 Patients enrolled

Trial Details

Trial ID

NCT00254202

Start Date

November 18 2005

End Date

March 21 2007

Last Update

December 13 2024

Active Locations (42)

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Page 1 of 11 (42 locations)

1

Vanda Investigational Site

Little Rock, Arkansas, United States, 72211

2

Vanda Investigational Site

Anaheim, California, United States, 92805

3

Vanda Investigational Site

Cerritos, California, United States, 90703

4

Vanda Investigational Site

Garden Grove, California, United States, 92845