Systematic Evaluation of Antiviral Medication in Schizophrenia

NCT ID: NCT00514449

Last Updated: 2018-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2016-09-30

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Valacyclovir

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.

Group Type: EXPERIMENTAL

Valacyclovir

Intervention Type: 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

Sugar pill

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanley Medical Research Institute

OTHER

Sponsor Role: collaborator

Wayne State University

OTHER

Sponsor Role: collaborator

Konasale Prasad

OTHER

Sponsor Role: lead

Responsible Party

Konasale Prasad

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Konasale Prasad, MD

Role: PRINCIPAL_INVESTIGATOR

Western Psychiatric Institute and Clinic

Vishwajit Nimgaonkar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Western Psychiatric Institute and Clinic

Matcheri Keshavan, MD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Rajaprabhakaran Rajarethinam, MD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

Wayne State University

Detroit, Michigan, United States

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 17033628 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22446565 (View on PubMed)

Other Identifiers

0602032

Identifier Type: -

Identifier Source: org_study_id