Systematic Evaluation of Antiviral Medication in Schizophrenia (SEAMS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Stanley Medical Research Institute
Wayne State University
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00514449
First received: August 8, 2007
Last updated: February 17, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: Valacyclovir + Antipsychotic
Drug: Placebo + Antipsychotic
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-blind Controlled Trial of Valacyclovir Add-on Treatment of HSV Positive Early Course Schizophrenia Patients

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • PANSS Positive and Negative Syndrome Scale for schizophrenia [ Time Frame: Baseline, Weeks 2, 4, 6, 10, 14, 18 ] [ Designated as safety issue: No ]
  • Cognitive Function Neuropsychological Battery (Gur Battery) [ Time Frame: Baseline, Week 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Structural MRI (changes in grey matter deficits), fMRI (brain oxygenation level dependent, BOLD, responses) [ Time Frame: Baseline, Week 18 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2007
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Valacyclovir + Antipsychotic
1 g PO BID x 4 weeks after 4 weeks it goes up to 1.5 g PO BID x 12 weeks
Placebo Comparator: 2 Drug: Placebo + Antipsychotic
2 pills twice a day x 4 weeks, after 4 weeks 3 pills twice a day x 12 weeks

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514449

Locations
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, Pennsylvania
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Stanley Medical Research Institute
Wayne State University
Investigators
Principal Investigator: Konasale Prasad, MD Western Psychiatric Institute and Clinic
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Konasale Prasad, MD, Western Psychiatric Instititute and Clinic
ClinicalTrials.gov Identifier: NCT00514449     History of Changes
Other Study ID Numbers: 0602032
Study First Received: August 8, 2007
Last Updated: February 17, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Valacyclovir
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on April 14, 2014