V3: Vancouver-Victoria Valacyclovir Trial for Early Psychosis

Psychosis Clinical Trial

Official title:

V3: Vancouver-Victoria Valacyclovir Trial for Early Psychosis

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

• Mental Disorders
• Psychosis
• Psychotic Disorders

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