Status:
COMPLETED
Research Study of Bipolar Mood Symptoms and Cognitive Problems
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This is a sixteen week, randomized, double-blind add-on study of valacyclovir versus placebo in approximately 60 outpatients meeting diagnostic criteria according to the Diagnostic and Statistical Man...
Detailed Description
Background Herpes Viral Infections and Mental Illness. Recent studies have suggested that chronic, recurrent infections with the herpes family of viruses may play a role in chronic mental illnesses s...
Eligibility Criteria
Inclusion
- Be between the ages of 18-65
- Have a diagnosis of Bipolar I or II disorder (as defined by DSM-IV)
- Be in active treatment with an outpatient psychiatrist
- Test positive for HSV1
- Demonstrate cognitive impairment on the RBANS as defined by a total score of less than 85 (i.e. greater than one standard deviation below normal).
Exclusion
- Either pregnant or nursing
- Have been diagnosed with any serious, unstable illnesses including HIV infection or other immunodeficiency condition, hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease and hypertension), endocrinologic, neurologic, immunologic, or hematologic disease. Illnesses that are currently well controlled and being treated are not grounds for exclusion.
- Have a history of hypersensitivity or intolerance to valacyclovir or acyclovir
- Meet criteria for DSM-IV substance abuse (except nicotine and caffeine) within the past 90 days
- Had Electroconvulsive Therapy (ECT) within three months prior to randomization
- Judged to be at serious suicidal risk; inability to provide informed consent.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00428298
Start Date
March 1 2007
End Date
October 1 2012
Last Update
April 11 2017
Active Locations (1)
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1
Johns Hopkins University School of Medicine, Dept. of Psychiatry
Baltimore, Maryland, United States, 21207