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Lithium Study: Pharmacogenomics of Mood Stabilizer Response in Bipolar Disorder

Do you have bipolar disorder? If so, you may be eligible to join a research study to better understand why lithium works well for some persons with bipolar disorder and not others.

If you have bipolar disorder, you know that the medications used to treat it often have different effects on each patient.  You also know that finding the right medication(s) for you is mostly a process of trial and error, a frustrating process that is often hard on both patients and their families.  This study is being done to find out more about if there are genes that influence whether patients with bipolar disorder benefit from a particular medication.  The purpose is to identify genes that affect the response to two medications commonly used for bipolar disorder: lithium and valproate (Depakote). 

The ultimate goal of this research is to develop a test that would help doctors know which medication has the best chance of helping patients like you – without the trial and error.

What are the benefits of being in the study?

  • You may help to improve the treatment of bipolar disorder for patients like you.
  • You have the opportunity to receive closely-monitored care for your illness at the Johns Hopkins University School of Medicine
  • You will receive payment for participating in the study; you may receive up to $400 depending upon the length of your participation.

What are the eligibility requirements?

  • Must be older than 18 years of age.
  • Must have Bipolar I Disorder.
  • Must not be pregnant during the course of the study.

What will you do in the study?

  • At the start of the study, you will receive a comprehensive diagnostic assessment, a review of your medical history, routine lab work, and a variety of self-report questionnaires and brief clinical rating scales.
  • Next, you will provide a small blood sample for DNA analysis and complete a 20-minute psychological test.
  • If you are already taking lithium and doing well, you will simply continue to do so and be followed for two years to see how well lithium continues to work for you. If you are not taking lithium, you will start on it and treated with the lithium until your symptoms are largely gone and you are taking lithium alone, then followed over a two year period to see if or when your symptoms return. 
  • If your symptoms cannot be controlled on lithium alone, you will be treated with valproate (Depakote) instead and followed for two years.  Both lithium and valproate are standard medications for bipolar disorder and are widely used.
  • You have the opportunity to receive closely-monitored care for your illness at the Johns Hopkins University School of Medicine. You may receive on-going care during the course of the study from our study psychiatrist, Dr. Francis Mondimore, at the Johns Hopkins Bayview Mood Disorders Clinic or you can continue to receive your clinical care from your current psychiatrist in close consultation with Dr. Mondimore while you participate in the study.

For more information, please contact:

The Mood Disorders Clinic at Johns Hopkins Bayview Medical Center
4940 Eastern Avenue, D2 East
Baltimore, Maryland 21224

Phone:  410-550-1652

Principal Investigator:    Peter Zandi, PhD, MPH, MHS
IRB Protocol Number:    NA_00043300

 

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