Skip to main content
OpenTrials
Completed

NCT Number: NCT00514449

Systematic Evaluation of Antiviral Medication in Schizophrenia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wayne State University, Detroit, Michigan, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valacyclovir

Drug

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

Drug

2 pills twice a day x 2 weeks, after 2 weeks 3 pills twice a day x 16 weeks along with antipsychotic

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Konasale Prasad

Other

Collaborators

  • Stanley Medical Research Institute
  • Wayne State University

Registry information

Official study title

A Randomized Double-blind Controlled Trial of Valacyclovir Add-on Treatment of HSV Positive Early Course Schizophrenia Patients

Acronym: SEAMS

Important dates

Study start
2007
Primary completion
2016
Study completion
2016
First posted
Aug 10, 2007
Registry last updated
Jun 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.