Research Study of Bipolar Mood Symptoms and Cognitive Problems

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT00428298
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Valacyclovir — DRUG
    Subjects take two 500 mg capsules twice daily for 16 weeks.
  • Placebo — DRUG
    Subjects take two 500 mg capsules twice daily for 16 weeks.

Study Details

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.

Key Dates

Start date
Mar 31, 2007
Status verified
Feb 2017
Primary completion
Aug 31, 2012
Completion
Oct 31, 2012

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Treatment Valacyclovir
    Subjects dispensed 500 mg capsules. Subjects take two 500 mg capsules twice daily for 16 weeks.
  • Placebo Comparator: Placebo Treatment
    Subjects dispensed 500 mg capsules. Subjects take two 500 mg capsules twice daily for 16 weeks.

Primary Outcome Measure

Percent Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status at 16 Weeks [ Time Frame: 16 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins University School of Medicine, Dept. of PsychiatryBaltimoreMaryland21207-

Find similar trials in Baltimore, MD

By condition
Bipolar disorder
By specialty
PsychiatryMental healthBehavioral health
By research site
Johns Hopkins University School of Medicine, Dept. of Psychiatry· Baltimore, MD

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