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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00254202
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : July 20, 2012
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: iloperidone Drug: active comparator Drug: placebo Phase 3

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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.
Study Start Date : November 2005
Primary Completion Date : September 2006
Estimated Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Iloperidone
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Positive and Negative Symptom Scale (PANSS) - Total Score

Secondary Outcome Measures :
  1. Pharmacogenetic analysis

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00254202


  Show 42 Study Locations
Sponsors and Collaborators
Vanda Pharmaceuticals
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00254202     History of Changes
Other Study ID Numbers: VP-VYV-683-3101
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: July 20, 2012
Last Verified: July 2012

Keywords provided by Vanda Pharmaceuticals:
Schizophrenia
Atypical antipsychotic
psychosis

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders