Skip to main content
OpenTrials
Completed

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.

Completed

Looking for future studies?

Notify Me

Key information

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

Loading trial locations.

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

Valacyclovir (Valtrex)

Drug

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.

Published trials that share one or more normalized conditions with this study.