Systematic Evaluation of Antiviral Medication in Schizophrenia (SEAMS)
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|ClinicalTrials.gov Identifier: NCT00514449|
Recruitment Status : Completed
First Posted : August 10, 2007
Results First Posted : May 9, 2018
Last Update Posted : June 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder||Drug: Valacyclovir Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized Double-blind Controlled Trial of Valacyclovir Add-on Treatment of HSV Positive Early Course Schizophrenia Patients|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
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.
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
Placebo Comparator: Sugar pill
2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks.
2 pills twice a day x 2 weeks, after 2 weeks 3 pills twice a day x 16 weeks along with antipsychotic
- PANSS Positive and Negative Syndrome Scale for Schizophrenia [ Time Frame: Baseline, Weeks 2, 4, 6, 10, 14, 18 ]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) [ Time Frame: Baseline, Week 18 ]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
- Changes in Grey Matter Deficit [ Time Frame: Baseline, Week 18 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514449
|United States, Michigan|
|Wayne State University|
|Detroit, Michigan, United States, 48201|
|United States, Pennsylvania|
|Western Psychiatric Institute and Clinic|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||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|