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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00175513
Other study ID # C04-0503
Secondary ID FHA: 2005-07TPD:
Status Completed
Phase Phase 2
First received September 11, 2005
Last updated April 12, 2011
Start date September 2005
Est. completion date September 2009

Study information

Verified date April 2011
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Valacyclovir (Valtrex)
Unspecified

Locations

Country Name City State
Canada Eric Martin Pavilion Victoria British Columbia
Canada Peace Arch Hospital White Rock British Columbia

Sponsors (2)

Lead Sponsor Collaborator
University of British Columbia Stanley Medical Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Unspecified Unspecified No
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