V3: Vancouver-Victoria Valacyclovir Trial for Early Psychosis - Full Text View

Sponsor:	University of British Columbia
Collaborator:	Stanley Medical Research Institute
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00175513

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 II

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:

MedlinePlus related topics: Mental Disorders Psychotic Disorders Schizophrenia

Drug Information available for: Valaciclovir Valacyclovir hydrochloride

U.S. FDA Resources

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:

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

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 February 09, 2012