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A Randomized Double-blind Controlled Trial of Valacyclovir Add-on Treatment of HSV Positive Early Course Schizophrenia Patients
The purpose of this study is to examine whether antiviral medication will help improve psychotic symptoms and cognition in individuals early in the course of schizophrenia or schizoaffective disorder who are exposed to herpes simplex virus, type 1 (HSV 1), a virus that causes commonly occurring and recurrent cold sores.
The main objective of the study is to evaluate the efficacy of add-on treatment of Valacyclovir (VAV), an antiviral medication, in the treatment of early course schizophrenia/schizoaffective disorder patients. Our main hypothesis is that the VAV add-on treatment will improve positive, negative and cognitive symptoms in herpes simplex virus (HSV) positive schizophrenia or schizoaffective disorder patients. We hypothesize that the grey matter reductions in specific brain regions (such as prefrontal regions) will improve in patients on VAV + antipsychotic compared to those on placebo + antipsychotic and the improvements in positive, negative and cognitive symptoms will be correlated with the grey matter changes.
Age
18 - 50 years
Sex
ALL
Healthy Volunteers
No
Wayne State University
Detroit, Michigan, United States
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States
Start Date
June 1, 2007
Primary Completion Date
September 1, 2016
Completion Date
September 1, 2016
Last Updated
June 14, 2018
31
ACTUAL participants
Valacyclovir
DRUG
Placebo
DRUG
Lead Sponsor
Konasale Prasad
Collaborators
NCT07455929
NCT06740383
Data Source & Attribution
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