V3: Vancouver-Victoria Valacyclovir Trial for Early Psychosis
Information source: University of British Columbia
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psychosis
Intervention: Valacyclovir (Valtrex) (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of British Columbia Official(s) and/or principal investigator(s):
William Honer, MD, Principal Investigator, Affiliation: University of British Columbia
Overall contact:
Barbara Humphries, Phone: 604-524-7844, Email: barhumph@interchange.ubc.ca
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.
Clinical Details
Official title: V3: Vancouver-Victoria Valacyclovir Trial for Early Psychosis
Study design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: 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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Barbara Humphries, Phone: 604-524-7844, Email: barhumph@interchange.ubc.ca
Peace Arch Hospital, White Rock, British Columbia, Canada; Recruiting
Eric Martin Pavilion, Victoria, British Columbia, Canada; Recruiting
Additional Information
Starting date: September 2005
Ending date: December 2008
Last updated: September 2, 2008
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