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V3: Vancouver-Victoria Valacyclovir Trial for Early Psychosis

Primary Purpose

Psychosis

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Valacyclovir (Valtrex)
Sponsored by
University of British Columbia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis focused on measuring Psychosis, early psychosis, first episode psychosis, schizophrenia, schizoaffective, schizophreniform, bipolar disorder, valtrex, valacyclovir.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eric Martin Pavilion
  • Peace Arch Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 11, 2005
Last Updated
April 12, 2011
Sponsor
University of British Columbia
Collaborators
Stanley Medical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00175513
Brief Title
V3: Vancouver-Victoria Valacyclovir Trial for Early Psychosis
Official Title
V3: Vancouver-Victoria Valacyclovir Trial for Early Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of British Columbia
Collaborators
Stanley Medical Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
Keywords
Psychosis, early psychosis, first episode psychosis, schizophrenia, schizoaffective, schizophreniform, bipolar disorder, valtrex, valacyclovir.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Valacyclovir (Valtrex)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Honer, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eric Martin Pavilion
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Peace Arch Hospital
City
White Rock
State/Province
British Columbia
Country
Canada

12. IPD Sharing Statement

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V3: Vancouver-Victoria Valacyclovir Trial for Early Psychosis

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