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Valacyclovir Clinical Trial

Double-Blind Placebo-Controlled Trial of VALACYCLOVIR in Cognive Impairment and Mood Systems of Bipolar Depression 

The goal of this study is to determine if a medication called Valacyclovir is an effective treatment for bipolar disorder. Valacyclovir is a medication that has been approved by the FDA for treatment of the herpes virus and might help alleviate mood symptoms and cognitive problems associated with bipolar disorder.     

The study will last 18-20 weeks and requires visits every other week. Participants will come to The Johns Hopkins Hosital for a screening visit during which they will talk with a psychiatrist, complete psychological testing, and have their blood drawn. If they meet criteria for the study, participants will receive Valacyclovir or a placebo for the next 16 weeks. A placebo is a sugar pill that is expected to have no effect. Participants will have a 50% chance of getting the placebo. Throughout the course of the study, neither participants nor researchers will know who is getting which treatment.

Participants will meet with the team psychiatrist every other week to check for symptoms and potential side effects. Participation includes free study medication, labs, and testing. Participants will also be paid and, after the study, be referred back to their treating psychiatrist with treatment recommendations.

If you are interested in participating in this study, please call 410-502-2586

PARTICIPATION CRITERIA

Inclusion Criteria:

  • Ages 18-65
  • Diagnosed with Bipolar I or II disorder
  • Tests positive for the herpes simplex 1 virus (to be done during screening) Click here for Viral Testing Information Sheet
  • Receive a score on a the psychological test that indicates at least mild cognitive impairment (Trouble concentrating or remembering)
  • Currently in outpatient treatment with a psychiatrist

Exclusion Criteria:

  • Current psychotic symptoms
  • Women who are pregnant or nursing 
  • Any serious, uncontrolled medical illness
  • Current drug or alcohol abuse
  • Currently receiving Electroconvulsive Shock Therapy (ECT), clozaril or depot neuroleptic
  • Judged to be at serious suicidal risk

DISCLAIMER

You have entered a web site that describes a Stanley Medical Research Institute funded collaborative study on the treatment of the depressive phase of bipolar disorder. This site is created solely for the purposes of providing background information about the study and tools to enhance participation in the study. If you are seeking immediate help for an affective (mood) disorder, we recommend that you contact a mental health provider. This web site is not set up to provide help or advice to individuals with bipolar disorder, nor to family members of friends of individuals with bipolar disorder.   
   

 

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