Systematic Evaluation of Antiviral Medication in Schizophrenia

Schizophrenia Clinical Trial

— SEAMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00514449
• Other study ID #: 0602032
• Status: Completed
• Phase: Phase 2
• Start date: June 2007
• Est. completion date: September 2016

Study information

• Verified date: May 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan
United States	Western Psychiatric Institute and Clinic	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Konasale Prasad	Stanley Medical Research Institute, Wayne State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PANSS Positive and Negative Syndrome Scale for Schizophrenia	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.	Baseline, Weeks 2, 4, 6, 10, 14, 18
Primary	Cognitive Function Neuropsychological Battery (Gur Battery)	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	Baseline, Week 18
Secondary	Changes in Grey Matter Deficit	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.	Baseline, Week 18