Research Study of Bipolar Mood Symptoms and Cognitive Problems - Full Text View

Purpose

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

U.S. FDA Resources

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

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

The primary outcome measure will be The primary outcome measure will be the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The secondary outcome measures will be the Young Mania Rating Scale (YMRS), the Positive and Negative Syndrome Scale (PANSS) and the Montgomery Asberg Depression Rating Scale (MADRS). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

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.
2: Placebo Comparator	Drug: Placebo Subjects take two 500 mg capsules twice daily for 16 weeks.

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Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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 ECT (Electroconvulsive Therapy) within three months prior to randomization
Judged to be at serious suicidal risk; inability to provide informed consent.

Contacts and Locations

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

Contacts


Contact: Andrea N Galatis, BS	410-502-2334	moodtrials@jhmi.edu

Contact: Tessa Ring, BA	410-502-2586

Locations


United States, Maryland
	Johns Hopkins University School of Medicine, Dept. of Psychiatry	Recruiting
	Baltimore, Maryland, United States, 21207
	Principal Investigator: Jennifer L Payne, MD

Sponsors and Collaborators

Johns Hopkins University

Stanley Medical Research Institute

Investigators


Principal Investigator:	Jennifer L Payne, MD	Johns Hopkins University

More Information

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

Study placed in the following topic categories:

Valacyclovir

Affective Disorders, Psychotic

Mental Disorders

Bipolar Disorder

Mood Disorders

Psychotic Disorders

Additional relevant MeSH terms:

Anti-Infective Agents

Pathologic Processes

Disease

Therapeutic Uses

Antiviral Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008

Sponsors and Collaborators:	Johns Hopkins University Stanley Medical Research Institute
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00428298