Phase 2
Completed N=60
Research Study of Bipolar Mood Symptoms and Cognitive Problems
Source: ClinicalTrials.gov NCT00428298 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Percent Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status at 16 Weeks — 10.1053; 3.6364 percentage of change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status at 16 Weeks |
10.1053; 3.6364 | — |
| SECONDARY Change From Baseline in Montgomery Asberg Depression Score at 16 Weeks |
27.94; 19.74; 11.5; 14.89 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00428298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.