V3: Vancouver-Victoria Valacyclovir Trial for Early Psychosis

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Collaborator: Stanley Medical Research Institute
• Treatments: Acyclovir; Valacyclovir

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