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Systematic Evaluation of Antiviral Medication in Schizophrenia (SEAMS)

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ClinicalTrials.gov Identifier: NCT00514449
Recruitment Status : Unknown
Verified February 2011 by University of Pittsburgh.
Recruitment status was:  Active, not recruiting
First Posted : August 10, 2007
Last Update Posted : February 18, 2011
Stanley Medical Research Institute
Wayne State University
Information provided by:
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 + Antipsychotic Drug: Placebo + Antipsychotic 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)
Estimated Enrollment : 150 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
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 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
Placebo Comparator: 2 Drug: Placebo + Antipsychotic
2 pills twice a day x 4 weeks, after 4 weeks 3 pills twice a day x 12 weeks

Primary Outcome Measures :
  1. PANSS Positive and Negative Syndrome Scale for schizophrenia [ Time Frame: Baseline, Weeks 2, 4, 6, 10, 14, 18 ]
  2. Cognitive Function Neuropsychological Battery (Gur Battery) [ Time Frame: Baseline, Week 18 ]

Secondary Outcome Measures :
  1. Structural MRI (changes in grey matter deficits), fMRI (brain oxygenation level dependent, BOLD, responses) [ Time Frame: Baseline, Week 18 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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

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

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
University of Pittsburgh
Stanley Medical Research Institute
Wayne State University
Principal Investigator: Konasale Prasad, MD Western Psychiatric Institute and Clinic

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Konasale Prasad, MD, Western Psychiatric Instititute and Clinic
ClinicalTrials.gov Identifier: NCT00514449     History of Changes
Other Study ID Numbers: 0602032
First Posted: August 10, 2007    Key Record Dates
Last Update Posted: February 18, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Antiviral Agents
Anti-Infective Agents