Research Study of Bipolar Mood Symptoms and Cognitive Problems
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Valacyclovir; Placebo
Intervention description: Subjects take two 500 mg capsules twice daily for 16 weeks.; Subjects take two 500 mg capsules twice daily for 16 weeks.
Intervention MeSH terms: Valacyclovir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bipolar; Cognitive; Attention; Memory; Manic Depression; Bi-polar

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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.