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Sponsors and Collaborators: |
Johns Hopkins University Stanley Medical Research Institute |
Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00428298 |
This is a sixteen-week, randomized, double-blind add-on study of valacyclovir versus placebo in approximately 60 outpatients meeting diagnostic criteria for DSM-IV Bipolar I or II disorder, testing positive for HSV-1 and who have demonstrable cognitive impairment defined as a total score of less than 85 (one standard deviation from the normal range) on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). Each patient will be randomized to double-blind treatment with either valacyclovir or placebo for sixteen weeks. All subjects will be maintained on a stable regimen of psychiatric drugs prescribed by their treating psychiatrist. Patients will be evaluated every 2 weeks by the treatment team and mood rating scales will be administered at each visit including the YMRS, PANSS and the MADRS. The RBANS will be administered again at 8 and 16 weeks. Both the treatment team and the patient will remain blinded during the course of the study. Following the active treatment phase, patients will receive treatment as clinically indicated.
Primary Hypothesis:
Valacyclovir will be superior to placebo in reducing cognitive symptoms associated with bipolar disorder in subjects who have been previously infected with Herpes Simplex virus I (HSV-1).
Secondary Hypothesis:
Valacyclovir will be superior to placebo in reducing mood symptoms associated with bipolar disorder in subjects who have been previously infected with HSV-1.
Condition | Intervention | Phase |
Bipolar Disorder |
Drug: Valacyclovir Drug: Placebo |
Phase II |
MedlinePlus related topics: | Bipolar Disorder |
ChemIDplus related topics: | Valaciclovir Valacyclovir hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Double Blind Placebo Controlled Study of Valacyclovir in Cognitive Impairment and Mood Symptoms of Bipolar Disorder |
Estimated Enrollment: | 60 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Drug: Valacyclovir
Subjects take two 500 mg capsules twice daily for 16 weeks.
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2: Placebo Comparator |
Drug: Placebo
Subjects take two 500 mg capsules twice daily for 16 weeks.
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Show Detailed Description |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Andrea N Galatis, BS | 410-502-2334 | moodtrials@jhmi.edu |
Contact: Tessa Ring, BA | 410-502-2586 |
United States, Maryland | |||||
Johns Hopkins University School of Medicine, Dept. of Psychiatry | Recruiting | ||||
Baltimore, Maryland, United States, 21207 | |||||
Principal Investigator: Jennifer L Payne, MD |
Johns Hopkins University |
Stanley Medical Research Institute |
Principal Investigator: | Jennifer L Payne, MD | Johns Hopkins University |
Responsible Party: | Johns Hopkins University School of Medicine ( Jennifer Payne, M.D. ) |
Study ID Numbers: | 06TGF-981 |
First Received: | January 29, 2007 |
Last Updated: | September 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00428298 |
Health Authority: | United States: Institutional Review Board |
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