Psychosis Clinical Trial
Official title:
V3: Vancouver-Victoria Valacyclovir Trial for Early Psychosis
Verified date | April 2011 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | September 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Eric Martin Pavilion | Victoria | British Columbia |
Canada | Peace Arch Hospital | White Rock | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | Stanley Medical Research Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Unspecified | Unspecified | No |
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