NCT Number: NCT00175513
V3: Vancouver-Victoria Valacyclovir Trial for Early Psychosis
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.
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Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Eric Martin Pavilion, Victoria, British Columbia, Canada
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Sponsors and collaborators
Lead sponsor
University of British Columbia
Other
Collaborators
- Stanley Medical Research Institute
Registry information
Important dates
- Study start
- 2005
- Primary completion
- 2009
- Study completion
- 2009
- First posted
- Sep 15, 2005
- Registry last updated
- Apr 14, 2011
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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