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

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00175513
First received: September 11, 2005
Last updated: April 12, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Psychosis
Drug: Valacyclovir (Valtrex)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: V3: Vancouver-Victoria Valacyclovir Trial for Early Psychosis

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Unspecified [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2005
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Valacyclovir (Valtrex)
    Unspecified
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.

  Eligibility

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

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
  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: NCT00175513

Locations
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
Investigators
Principal Investigator: William Honer, MD University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. William Honer, University of British Columbia
ClinicalTrials.gov Identifier: NCT00175513     History of Changes
Other Study ID Numbers: C04-0503, FHA: 2005-07, TPD: 094295
Study First Received: September 11, 2005
Last Updated: April 12, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Psychosis
early psychosis
first episode psychosis
schizophrenia
schizoaffective
schizophreniform
bipolar disorder
valtrex
valacyclovir.

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014