Trial record 1 of 1 for:    NCT00175513
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V3: Vancouver-Victoria Valacyclovir Trial for Early Psychosis

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. Identifier: NCT00175513
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : April 14, 2011
Stanley Medical Research Institute
Information provided by:
University of British Columbia

Brief Summary:
This is an 18 week (2 weeks run-in, 16 weeks double blind) trial, to determine if an antiviral drug, valacyclovir (Valtrex) is helpful in treating the symptoms of psychosis, a form of a mental disorder.

Condition or disease Intervention/treatment Phase
Psychosis Drug: Valacyclovir (Valtrex) Phase 2

Detailed Description:

There is evidence that some of the symptoms of psychosis may be related to past infection with common viruses.

Researchers are looking to recruit a total of 100 subjects with evidence in the past, of exposure to at least 1 of 3 viruses. The viruses include herpes type 1 (HSV-1, which causes cold sores of the lip and has affected about 6/10 people in Vancouver), herpes type 2 (HSV-2 which causes genital sores, and has affected less than 1/10 people in Vancouver) and cytomegalovirus (CMV, which causes few symptoms but has affected 8/10 people in Vancouver). People who have been infected with these viruses in the past develop antibodies in the blood. The antibodies can be measured in blood, and are a test of whether or not there was infection in the past, and possibly affecting the symptoms of psychosis.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: V3: Vancouver-Victoria Valacyclovir Trial for Early Psychosis
Study Start Date : September 2005
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects antipsychotic, mood stabilizing and antidepressant drug treatment must have been stable for at least 3 months, and there is no plan to change the drug treatment during the 4-month phase of the study.
  • Subjects must be seropositive for HSV-1, HSV-2 and/or CMV.
  • Subjects must achieve a level of understanding and expressive capacity sufficient to communicate adequately with the study coordinator and to participate in cognitive testing.
  • Subjects must be able to provide written informed consent.

Exclusion Criteria:

  • Females of childbearing age will agree not to become pregnant and will agree to use a medically acceptable method of birth control.
  • Inability to participate in cognitive testing due to severe persistent psychosis or other condition.
  • Mental handicap.
  • Subjects with known hypersensitivity or allergy to valacyclovir or acyclovir.
  • Patient taking nontopical antiviral medications with anti-herpes activity on a regular basis

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 identifier (NCT number): NCT00175513

Canada, British Columbia
Eric Martin Pavilion
Victoria, British Columbia, Canada
Peace Arch Hospital
White Rock, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Stanley Medical Research Institute
Principal Investigator: William Honer, MD University of British Columbia

Responsible Party: Dr. William Honer, University of British Columbia Identifier: NCT00175513     History of Changes
Other Study ID Numbers: C04-0503
FHA: 2005-07
TPD: 094295
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: April 14, 2011
Last Verified: April 2011

Keywords provided by University of British Columbia:
early psychosis
first episode psychosis
bipolar disorder

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Antiviral Agents
Anti-Infective Agents