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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. 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.
Interventions
- DRUG Placebo
- DRUG Valacyclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2007-03 |
| Est. Completion | 2012-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00428298
The ClinicalTrials.gov registry entry for NCT00428298 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00428298 reports 0 study locations.
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.
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