Status:
COMPLETED
Valacyclovir Augmentation for Cognitive and Functional Remediation in Schizophrenia
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Dr. Ram Manohar Lohia Hospital
Stanley Medical Research Institute
Conditions:
Herpes Simplex
Schizophrenia
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief 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 he...
Detailed Description
Design: We propose a randomized double blind placebo controlled study of patients with early course Schizophrenia (SZ) / schizoaffective disorder (SZA) patients exposed to HSV-1, who are receiving ant...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT01794897
Start Date
February 1 2013
End Date
September 1 2016
Last Update
October 26 2016
Active Locations (1)
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1
Dr. Ram Manohar Lohia Hospital
Delhi, India