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Research Study of Bipolar Mood Symptoms and Cognitive Problems

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00428298
First received: January 29, 2007
Last updated: February 28, 2017
Last verified: February 2017
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder Drug: Valacyclovir Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind Placebo Controlled Study of Valacyclovir in Cognitive Impairment and Mood Symptoms of Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

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

    The RBANS is a brief, independently administered measurement of cognitive decline or improvement.

    The test is comprised of 12 subtests which comprise 5 domains. The age of the participant and the scores from each domain inform the total RBANS score (Index Score) analyzed in this study. The range for total score is 40-160. If the total score for a subject increases this denotes improved performance on the RBANS.

    The RBANS was administered at baseline and 16 weeks.



Secondary Outcome Measures:
  • Change From Baseline in Montgomery Asberg Depression Score at 16 Weeks [ Time Frame: 16 weeks ]
    The MADRS is a 10 item depression rating scale administered by a research team member. The MADRS is composed of 10 items with a 7 point fixed rating scale (0-6). A higher score indicates the presence of depressive symptoms.


Other Outcome Measures:
  • Change From Baseline in Young Mania Rating Scale (YMRS) at 16 Weeks [ Time Frame: 16 weeks ]

    The Young Mania Rating Scale has 11 items that rate the subject's subjective experience and clinician observation. Four items are rated 0-8, the remaining are rated 0-4.

    The score can range from 0 to 60. A higher score indicates the presence of manic symptoms.



Enrollment: 60
Study Start Date: March 2007
Study Completion Date: October 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Treatment Valacyclovir
Subjects dispensed 500 mg capsules. Subjects take two 500 mg capsules twice daily for 16 weeks.
Drug: Valacyclovir
Subjects take two 500 mg capsules twice daily for 16 weeks.
Other Name: Valtrex
Placebo Comparator: Placebo Treatment
Subjects dispensed 500 mg capsules. Subjects take two 500 mg capsules twice daily for 16 weeks.
Drug: Placebo
Subjects take two 500 mg capsules twice daily for 16 weeks.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428298

Locations
United States, Maryland
Johns Hopkins University School of Medicine, Dept. of Psychiatry
Baltimore, Maryland, United States, 21207
Sponsors and Collaborators
Johns Hopkins University
Stanley Medical Research Institute
Investigators
Principal Investigator: Jennifer L Payne, MD Johns Hopkins University
  More Information

Additional Information:
Publications:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00428298     History of Changes
Other Study ID Numbers: 00009034
Study First Received: January 29, 2007
Results First Received: September 20, 2016
Last Updated: February 28, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Johns Hopkins University:
Bipolar
Cognitive
Attention
Memory
Manic Depression
Bi-polar

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 18, 2017