Systematic Evaluation of Antiviral Medication in Schizophrenia

NCT00514449 | Completed Phase 2 Results

• 1 other identifier: 0602032
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Changes in Grey Matter Deficit

  Baseline, Week 18

Study Arms (2)

Valacyclovir

EXPERIMENTAL

1 gram pill taken twice a day for 2 weeks, after 2 weeks it increased to 1.5 gram pill taken twice a day for 16 weeks.

Drug: Valacyclovir

Sugar pill

PLACEBO COMPARATOR

2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks.

Drug: Placebo

Interventions

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

Valacyclovir

Placebo DRUG

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

Sugar pill

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konasale Prasad: lead
• Stanley Medical Research Institute: collaborator
• Wayne State University: collaborator

Study Sites (2)

Wayne State University

Detroit, Michigan, 48201, United States

Location

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• 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.

  PMID: 17033628 BACKGROUND

• 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.

  PMID: 22446565 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

This was a small sample study designed as a proof of concept. A larger study will follow.

Results Point of Contact

• Title: Dr. Konasale Prasad
• Organization: Western Psychiatric Institute and Clinic

prasadkm@upmc.edu

412-586-9014

Study Officials

• Konasale Prasad, MD

  Western Psychiatric Institute and Clinic

  PRINCIPAL INVESTIGATOR

• Vishwajit Nimgaonkar, MD, PhD

  Western Psychiatric Institute and Clinic

  PRINCIPAL INVESTIGATOR

• Matcheri Keshavan, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

• Rajaprabhakaran Rajarethinam, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 8, 2007
• First Posted: August 10, 2007
• Study Start: June 1, 2007
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: June 14, 2018
• Results First Posted: May 9, 2018

Record last verified: 2018-05

Locations

US (2)