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Systematic Evaluation of Antiviral Medication in Schizophrenia (SEAMS)

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ClinicalTrials.gov Identifier: NCT00514449
Recruitment Status : Completed
First Posted : August 10, 2007
Results First Posted : May 9, 2018
Last Update Posted : May 9, 2018
Sponsor:
Collaborators:
Stanley Medical Research Institute
Wayne State University
Information provided by (Responsible Party):
Konasale Prasad, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: Valacyclovir Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-blind Controlled Trial of Valacyclovir Add-on Treatment of HSV Positive Early Course Schizophrenia Patients
Study Start Date : June 2007
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Drug: Valacyclovir
1 g PO BID x 2 weeks after 2 weeks it goes up to 1.5 g PO BID x 16 weeks along with antipsychotic
Placebo Comparator: Sugar pill
2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks.
Drug: Placebo
2 pills twice a day x 2 weeks, after 2 weeks 3 pills twice a day x 16 weeks along with antipsychotic



Primary Outcome Measures :
  1. PANSS Positive and Negative Syndrome Scale for Schizophrenia [ Time Frame: 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.

  2. Cognitive Function Neuropsychological Battery (Gur Battery) [ Time Frame: 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 :
  1. Changes in Grey Matter Deficit [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514449


Locations
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, Pennsylvania
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Konasale Prasad
Stanley Medical Research Institute
Wayne State University
Investigators
Principal Investigator: Konasale Prasad, MD Western Psychiatric Institute and Clinic
Principal Investigator: Vishwajit Nimgaonkar, MD, PhD Western Psychiatric Institute and Clinic
Principal Investigator: Matcheri Keshavan, MD Wayne State University
Principal Investigator: Rajaprabhakaran Rajarethinam, MD Wayne State University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Konasale Prasad, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00514449     History of Changes
Other Study ID Numbers: 0602032
First Posted: August 10, 2007    Key Record Dates
Results First Posted: May 9, 2018
Last Update Posted: May 9, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents