Research Study of Bipolar Mood Symptoms and Cognitive Problems
Recruitment status was Active, not recruiting
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
- 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 ]
- 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: | October 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Valacyclovir
Subjects take two 500 mg capsules twice daily for 16 weeks.
Other Name: Valtrex
|
| Placebo Comparator: 2 |
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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, Maryland | |
| Johns Hopkins University School of Medicine, Dept. of Psychiatry | |
| Baltimore, Maryland, United States, 21207 | |
| Principal Investigator: | Jennifer L Payne, MD | Johns Hopkins University |
More Information
Additional Information:
Publications:
| Responsible Party: | Jennifer Payne, M.D., Johns Hopkins University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00428298 History of Changes |
| Other Study ID Numbers: | 06TGF-981 |
| Study First Received: | January 29, 2007 |
| Last Updated: | May 18, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Johns Hopkins University:
|
Bipolar Cognitive Attention |
Memory Manic Depression Bi-polar |
Additional relevant MeSH terms:
|
Bipolar Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders Valacyclovir |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013