Overview
Valacyclovir Augmentation for Cognitive and Functional Remediation in Schizophrenia
Status:
Completed
Completed
Trial end date:
2016-09-01
2016-09-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The effects of Valacyclovir (VAV) augmentation or placebo (PLA) as adjuncts to conventional antipsychotic drug treatment will be evaluated among patients with schizophrenia who have been exposed to herpes simplex virus type 1 (HSV-1). Hypothesis: Valacyclovir (VAV) augmentation improves (a) cognitive and (b) overall function among Herpes Simples Virus 1 (HSV-1) exposed early course schizophrenia patients.Phase:
Phase 4Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
University of PittsburghCollaborators:
Dr. Ram Manohar Lohia Hospital
Stanley Medical Research InstituteTreatments:
Acyclovir
Valacyclovir
Criteria
Inclusion Criteria:- Written informed consent.
- Both genders, ages 18-50 years
- Schizophrenia / schizoaffective disorder (DSM IV).
- Stable dose of antipsychotic for > 1 month, continued throughout the study.
- Score 4 or more on one or more items of the Positive and Negative Syndrome Scale.
- Exposed to HSV-1: serum antibody assays.
Exclusion Criteria:
- Substance abuse in the past month/dependence past 6 months.
- History / current medical /neurological illnesses e.g., epilepsy.
- Pregnancy.
- History of immune disorders, HIV infection, or receiving immune-suppressants.
- Receiving regular antiviral therapy.
- History of hypersensitivity to Valacyclovir.
- Mental retardation as defined in DSM IV.