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

This study has been completed.
Information provided by:
Vanda Pharmaceuticals
ClinicalTrials.gov Identifier:
First received: November 10, 2005
Last updated: July 18, 2012
Last verified: July 2012
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
Drug: iloperidone
Drug: active comparator
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:

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
Estimated Study Completion Date: March 2007
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
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.


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: November 10, 2005
Last Updated: July 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanda Pharmaceuticals:
Atypical antipsychotic

Additional relevant MeSH terms:
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 04, 2016