Research Study of Bipolar Mood Symptoms and Cognitive Problems
Status:
Completed
Trial end date:
2012-10-01
Target enrollment:
Participant gender:
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 Manual of Mental Disorders (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 Young Mania Rating Scale (YMRS) and
the Montgomery Asberg Depression Rating Scale (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.