V3: Vancouver-Victoria Valacyclovir Trial for Early Psychosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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V3: Vancouver-Victoria Valacyclovir Trial for Early Psychosis

Conditions
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Psychosis

Intervention / Treatment
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* Drug: Valacyclovir (Valtrex)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Valacyclovir (Valtrex)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychosis, early psychosis, first episode psychosis, schizophrenia, schizoaffective, schizophreniform, bipolar disorder, valtrex, valacyclovir.