Back to results

Systematic Evaluation of Antiviral Medication in Schizophrenia (SEAMS)

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Valacyclovir

Placebo

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Wayne State University
Western Psychiatric Institute and Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Valacyclovir

Sugar pill

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00514449

First Posted

August 8, 2007

Last Updated

May 15, 2018

Sponsor

Konasale Prasad

Collaborators

Stanley Medical Research Institute, Wayne State University

1. Study Identification

Unique Protocol Identification Number

NCT00514449

Brief Title

Systematic Evaluation of Antiviral Medication in Schizophrenia

Acronym

SEAMS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Konasale Prasad

Collaborators

Stanley Medical Research Institute, Wayne State University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Schizoaffective Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Valacyclovir

Arm Type

Experimental

Arm Description

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.

Arm Title

Sugar pill

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Valacyclovir

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

PANSS Positive and Negative Syndrome Scale for Schizophrenia

Description

Time Frame

Baseline, Weeks 2, 4, 6, 10, 14, 18

Title

Cognitive Function Neuropsychological Battery (Gur Battery)

Description

Time Frame

Baseline, Week 18

Secondary Outcome Measure Information:

Title

Changes in Grey Matter Deficit

Description

Time Frame

Baseline, Week 18

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Konasale Prasad, MD

Organizational Affiliation

Western Psychiatric Institute and Clinic

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Vishwajit Nimgaonkar, MD, PhD

Organizational Affiliation

Western Psychiatric Institute and Clinic

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Matcheri Keshavan, MD

Organizational Affiliation

Wayne State University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rajaprabhakaran Rajarethinam, MD

Organizational Affiliation

Wayne State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wayne State University

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Western Psychiatric Institute and Clinic

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17033628

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.

Results Reference

background

PubMed Identifier

22446565

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.

Results Reference

derived

Learn more about this trial

Systematic Evaluation of Antiviral Medication in Schizophrenia

We'll reach out to this number within 24 hrs