Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia - Full Text View

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: iloperidone Drug: active comparator Drug: placebo	Phase III

MedlinePlus related topics:

Schizophrenia

Drug Information available for:

Iloperidone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	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.

Further study details as provided by Vanda Pharmaceuticals:

Primary Outcome Measures:

Positive and Negative Symptom Scale (PANSS) - Total Score

Secondary Outcome Measures:

Pharmacogenetic analysis

Estimated Enrollment:	600
Study Start Date:	November 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject with schizophrenia.
Subject must sign a written consent form.

Exclusion Criteria:

Clinically significant disease of the heart, kidneys, liver or gastrointestinal system
Psychiatric disorder other than schizophrenia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254202

Show 42 Study Locations

Sponsors and Collaborators

Vanda Pharmaceuticals

More Information

Study ID Numbers:	VP-VYV-683-3101
First Received:	November 10, 2005
Last Updated:	October 2, 2007
ClinicalTrials.gov Identifier:	NCT00254202
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vanda Pharmaceuticals:

Schizophrenia

Atypical antipsychotic

psychosis

Study placed in the following topic categories:

Schizophrenia

Mental Disorders

Psychotic Disorders

Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 06, 2008

Sponsored by:	Vanda Pharmaceuticals
Information provided by:	Vanda Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00254202