Systematic Evaluation of Antiviral Medication in Schizophrenia

Phase 2

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Substance abuse in the last month/dependence 6 months prior to the study
History of, or current medical/neurological illnesses which affects CNS function e.g., epilepsy, head injury with prolonged loss of consciousness
Pregnancy
History of immune disorders, HIV infection or currently receiving immunosuppressants
Subjects on regular antiviral therapy
History of hypersensitivity to Valacyclovir
Mental retardation as defined in DSM-IV

Arm && Interventions

Group	Intervention	Description
Valacyclovir	Valacyclovir	1 gram pill taken twice a day for 2 weeks, after 2 weeks it increased to 1.5 gram pill taken twice a day for 16 weeks.
Sugar pill	Placebo	2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks.

Primary Outcome Measures

Name	Time	Method
PANSS Positive and Negative Syndrome Scale for Schizophrenia	Baseline, Weeks 2, 4, 6, 10, 14, 18	This is a structured measure of severity of psychopathology that includes both positive and negative symptoms. The range is a minimum score of 30 and the maximum is 210. The lower scores suggest milder severity of illness domains.
Cognitive Function Neuropsychological Battery (Gur Battery)	Baseline, Week 18	All results are given as the mean difference between an 18 week follow-up and the baseline battery administrations.This is a computerized test that measures both accuracy and response times. A range for response times is not available because of individual variabilities. Accuracy scores can vary for each test: Working memory accuracy range was 0-16. Verbal memory accuracy range was 0-20. For both, the higher the score the better. No cut offs are available

Secondary Outcome Measures

Name	Time	Method
Changes in Grey Matter Deficit	Baseline, Week 18	Gray matter volume changes (in cc) were measured using structural MRI. Changes were reported as gray matter volume in cc. Note: Assessment of blood oxygenation level dependent (BOLD) changes using fMRI were erroneously included in the original study record.

Locations (2): Wayne State University
🇺🇸
Detroit, Michigan, United States
Western Psychiatric Institute and Clinic
🇺🇸
Pittsburgh, Pennsylvania, United States
Wayne State University
🇺🇸Detroit, Michigan, United States