Schizophrenia Clinical Trial
Official title:
A Double-Blind Trial of Adjunctive Valacyclovir to Improve Cognition in Early Phase Schizophrenia
The primary aim of the study is to determine the efficacy of adjunctive valacyclovir, in
comparison to placebo, to improve visual (Brief Visuospatial Memory Test) and working
(composite score of the Spatial Span and Letter Number Span tests) memory in individuals who
are HSV-1 positive and early in the course of schizophrenia.
We hypothesize that individuals who are HSV-1 positive, but not those who are HSV-1 negative,
will demonstrate significant valacyclovir efficacy for visual and working memory.
One hundred and seventy-five participants (N=70 HSV-1 seropositive and N=105 HSV-1 seronegative) will be randomized 1:1 to receive adjunctive valacyclovir or adjunctive placebo for a 16 week period. The primary outcome that will be assessed is improvement in changes in visual and working memory scores in HSV-1 positive and negative participants over the course of the study. We will also measure the overall cognitive functioning and the severity of psychiatric symptoms over the course of the study and will evaluate the tolerability and safety of valacyclovir treatment in this population. In addition, we will explore the relationship between changes in the levels of inflammatory markers (HSV2, CMV, EBV, CRP, and Toxoplasmosis) and treatment response over the course of the study. ;
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