Official Title: “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 recurrent cold sores.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: January 2010

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.

Intervention(s) in this Clinical Trial

• Drug: Valacyclovir + Antipsychotic
  • 1g po BID x 4 Weeks After 4 week it goes up to 1.5 g po BID x 12 weeks
• Drug: Placebo + Antipsychotic
  • 2 pills twice a day x 4 weeks, after 4 weeks 3 pills twice a day x 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Placebo Comparator: 2

Primary Measures

• PANSS Positive and Negative Syndrome Scale for Schizophrenia
  • Time Frame: Baseline, Weeks 2, 4, 6, 10, 14, 18
    Safety Issue?: No
• Cognitive Function Neuropsychological Battery (Gur Battery)
  • Time Frame: Baseline, Week 18
    Safety Issue?: No

Secondary Measures

• structural MRI (changes in grey matter deficits) fMRI (brain oxygenation level dependent, BOLD, responses)
  • Time Frame: Baseline, Week 18
    Safety Issue?: No

Inclusion Criteria:

• Both genders between the ages of 18-50 years
• Schizophrenia or schizoaffective disorder as defined in DSM IV
• Duration of illness 10 years or less
• On a stable dose of an antipsychotic medication for at least a month
• Should score 4 or more on at least one of the subscales of PANSS
• Positive for HSV1
• Written informed consent

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Pittsburgh

Overall Clinical Trial Officials and Contacts

Konasale Prasad, MD Principal Investigator Western Psychiatric Institute and Clinic  

Overall Contact: Alicia Thomas, BA 1-866-461-3219 thomasaa@upmc.edu

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00514449

Study ID Number: 0602032

ClinicalTrials.gov Identifier: NCT00514449

Health Authority: United States: Institutional Review Board