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NCT00428298 · ClinicalTrials.gov registry record · Phase 2
Research Study of Bipolar Mood Symptoms and Cognitive Problems
A Phase 2 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT00428298: Completed Phase 2 study, sponsored by Johns Hopkins University.
NCT00428298 is a Phase 2 study that has completed, run by Johns Hopkins University. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00428298, a Phase 2 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Valacyclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2007-03 |
| Est. Completion | 2012-10 |
| Phase | Phase 2 |
What the finished NCT00428298 record still lists
NCT00428298 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00428298 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00428298 about?
NCT00428298 is a clinical study titled "Research Study of Bipolar Mood Symptoms and Cognitive Problems". 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 ...
What is the current status of trial NCT00428298?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2007-03. Estimated completion is 2012-10.
What interventions are being tested in trial NCT00428298?
The interventions under investigation include: Placebo (DRUG), Valacyclovir (DRUG).
Who is sponsoring clinical trial NCT00428298?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00428298's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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