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
Recruitment status was Active, not recruiting
Sponsor:
University of Pittsburgh
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
| 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 May 16, 2013