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Systematic Evaluation of Antiviral Medication in Schizophrenia (SEAMS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Stanley Medical Research Institute
Wayne State University
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00514449
First received: August 8, 2007
Last updated: February 17, 2011
Last verified: February 2011
History of Changes

August 8, 2007
February 17, 2011
June 2007
January 2010   (final data collection date for primary outcome measure)
  • PANSS Positive and Negative Syndrome Scale for schizophrenia [ Time Frame: Baseline, Weeks 2, 4, 6, 10, 14, 18 ] [ Designated as safety issue: No ]
  • Cognitive Function Neuropsychological Battery (Gur Battery) [ Time Frame: Baseline, Week 18 ] [ Designated as safety issue: No ]
  • PANSS Positive and Negative Syndrome Scale for Schizophrenia [ Time Frame: Baseline, Weeks 2, 4, 6, 10, 14, 18 ]
  • Cognitive Function Neuropsychological Battery (Gur Battery) [ Time Frame: Baseline, Week 18 ]
Complete list of historical versions of study NCT00514449 on ClinicalTrials.gov Archive Site
Structural MRI (changes in grey matter deficits), fMRI (brain oxygenation level dependent, BOLD, responses) [ Time Frame: Baseline, Week 18 ] [ Designated as safety issue: No ]
structural MRI (changes in grey matter deficits) fMRI (brain oxygenation level dependent, BOLD, responses) [ Time Frame: Baseline, Week 18 ]
Not Provided
Not Provided
 
Systematic Evaluation of Antiviral Medication in Schizophrenia
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 and recurrent cold sores.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
  • 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
  • Drug: Placebo + Antipsychotic
    2 pills twice a day x 4 weeks, after 4 weeks 3 pills twice a day x 12 weeks
  • Active Comparator: 1
    Intervention: Drug: Valacyclovir + Antipsychotic
  • Placebo Comparator: 2
    Intervention: Drug: Placebo + Antipsychotic
Prasad KM, Shirts BH, Yolken RH, Keshavan MS, Nimgaonkar VL. Brain morphological changes associated with exposure to HSV1 in first-episode schizophrenia. Mol Psychiatry. 2007 Jan;12(1):105-13, 1. Epub 2006 Oct 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
February 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00514449
0602032
No
Konasale Prasad, MD, Western Psychiatric Instititute and Clinic
University of Pittsburgh
  • Stanley Medical Research Institute
  • Wayne State University
Principal Investigator: Konasale Prasad, MD Western Psychiatric Institute and Clinic
University of Pittsburgh
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP