Clinical trial NCT00514449: Systematic Evaluation of Antiviral Medication in Schizophrenia
Official title: A Randomized Double-blind Controlled Trial of Valacyclovir Add-on Treatment of HSV Positive Early Course Schizophrenia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Stanley Medical Research Institute
name: Wayne State University
First posted: 2007-08-10
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: PANSS Positive and Negative Syndrome Scale for Schizophrenia
timeFrame: Baseline, Weeks 2, 4, 6, 10, 14, 18
measure: Cognitive Function Neuropsychological Battery (Gur Battery)
timeFrame: Baseline, Week 18
Secondary outcomes:
measure: Changes in Grey Matter Deficit
timeFrame: Baseline, Week 18
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Pittsburgh
country: United States
facility: Western Psychiatric Institute and Clinic
state: Pennsylvania
Study officials:
affiliation: Western Psychiatric Institute and Clinic
name: Konasale Prasad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Western Psychiatric Institute and Clinic
name: Vishwajit Nimgaonkar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University
name: Matcheri Keshavan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University
name: Rajaprabhakaran Rajarethinam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1038/sj.mp.4001915. Epub 2006 Oct 10.
citation: Prasad KM, Eack SM, Keshavan MS, Yolken RH, Iyengar S, Nimgaonkar VL. Antiherpes virus-specific treatment and cognition in schizophrenia: a test-of-concept randomized double-blind placebo-controlled trial. Schizophr Bull. 2013 Jul;39(4):857-66. doi: 10.1093/schbul/sbs040. Epub 2012 Mar 23.