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Sponsors and Collaborators: |
University of Pittsburgh Stanley Medical Research Institute Wayne State University |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00514449 |
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.
Condition | Intervention | Phase |
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Schizophrenia Schizoaffective Disorder |
Drug: Valacyclovir + Antipsychotic Drug: Placebo + Antipsychotic |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Double-Blind Controlled Trial of Valacyclovir Add-on Treatment of HSV Positive Early Course Schizophrenia Patients |
Estimated Enrollment: | 150 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: Valacyclovir + Antipsychotic
1 g PO BID x 4 weeks after 4 weeks it goes up to 1.5 g PO BID x 12 weeks
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2: Placebo Comparator |
Drug: Placebo + Antipsychotic
2 pills twice a day x 4 weeks, after 4 weeks 3 pills twice a day x 12 weeks
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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.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alicia Thomas, BA | 1-866-461-3219 | thomasaa@upmc.edu |
Contact: Debra M. Montrose, PhD, LSW | 412-586-9020 | montrosedm@upmc.edu |
United States, Michigan | |
Wayne State University | Recruiting |
Detroit, Michigan, United States, 48201 | |
Contact: Myung Mae Nordin mnordin@med.wayne.edu | |
Sub-Investigator: Matcheri Keshavan, MD | |
United States, Pennsylvania | |
Western Psychiatric Institute and Clinic | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
Contact: Alicia Thomas, BA 412-586-9096 thomasaa@upmc.edu | |
Principal Investigator: Konasale Prasad, MD |
Principal Investigator: | Konasale Prasad, MD | Western Psychiatric Institute and Clinic |
Responsible Party: | Western Psychiatric Instititute and Clinic ( Konasale Prasad, MD ) |
Study ID Numbers: | 0602032 |
Study First Received: | August 8, 2007 |
Last Updated: | July 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00514449 History of Changes |
Health Authority: | United States: Institutional Review Board |
Valacyclovir Schizophrenia Anti-Infective Agents Tranquilizing Agents Mental Disorders Psychotropic Drugs |
Central Nervous System Depressants Psychotic Disorders Antipsychotic Agents Antiviral Agents Schizophrenia and Disorders with Psychotic Features |
Anti-Infective Agents Tranquilizing Agents Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Antiviral Agents Pharmacologic Actions |
Schizophrenia Valacyclovir Mental Disorders Therapeutic Uses Psychotic Disorders Central Nervous System Agents Schizophrenia and Disorders with Psychotic Features |