Systematic Evaluation of Antiviral Medication in Schizophrenia

Condition(s) targeted: Schizophrenia; Schizoaffective Disorder

Intervention: Valacyclovir + Antipsychotic (Drug); Placebo + Antipsychotic (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Pittsburgh

Official(s) and/or principal investigator(s):
Konasale Prasad, MD, Principal Investigator, Affiliation: Western Psychiatric Institute and Clinic

Overall contact:
Alicia Thomas, BA, Phone: 1-866-461-3219, Email: thomasaa@upmc.edu

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.

Official title: A Randomized Double-Blind Controlled Trial of Valacyclovir Add-on Treatment of HSV Positive Early Course Schizophrenia Patients

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:

PANSS Positive and Negative Syndrome Scale for schizophrenia

Cognitive Function Neuropsychological Battery (Gur Battery)

Secondary outcome: Structural MRI (changes in grey matter deficits), fMRI (brain oxygenation level dependent, BOLD, responses)

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.

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

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

Alicia Thomas, BA, Phone: 1-866-461-3219, Email: thomasaa@upmc.edu

Wayne State University, Detroit, Michigan 48201, United States; Recruiting
Myung Mae Nordin, Email: mnordin@med.wayne.edu
Matcheri Keshavan, MD, Sub-Investigator

Western Psychiatric Institute and Clinic, Pittsburgh, Pennsylvania 15213, United States; Recruiting
Alicia Thomas, BA, Phone: 412-586-9096, Email: thomasaa@upmc.edu
Konasale Prasad, MD, Principal Investigator

Related publications:

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.

Starting date: June 2007
Ending date: February 2010
Last updated: July 6, 2009