Department of Psychiatry
Penn Behavioral Health

Center for Neurobiology and Behavior

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Pharmacogenomics of Mood Stabilizer Response in Bipolar Disorder (PGBD)


Principle Investigators:
Wade Berrettini, MD, PhD & Falk Lohoff, MD
Study Coordinator: Candice Schwebel


General Description

The Pharmacogenomics of Bipolar Disorder study (PGBD) is a research study of patients with bipolar disorder and the role of genes in their response to medications. The study focuses on two of the most commonly used mood stabilizing medications, lithium and valproate (Depakote®). The goal is to identify the genes that influence whether a patient will have a good response to these medications.


Reasons to participate

  • You will help advance our understanding of how lithium works and what causes bipolar disorder
  • You will contribute to improving the treatment of people with bipolar disorder
  • You will contribute to the development of a genetic test that may one day help doctors select the best medication for each patient


Eligibility

In order to be eligible for the study, you must:

  • Be currently taking lithium and it is working for you
  • Be at least 18 years old and have been diagnosed with Bipolar I Disorder.
  • Have never failed to respond to lithium (as a single medication) in the past
  • Have never failed to tolerate lithium in the past
  • Be medically stable and have healthy kidneys
  • Be willing and able to travel to our research lab on the University of Pennsylvania campus in Philadelphia for evaluation, psychiatric care and research tests and assessment.
  • Be able to provide informed consent
  • Women of child-bearing potential must agree to use adequate contraception and to inform their doctor at the earliest possible time, if they plan to conceive,
  • Have medical insurance coverage to pay for treatment services that are not research-related, which include physician visits, cost of medication, routine laboratory work and an EKG, if over the age of 40


What to Expect

As a participant in the study, you will:

  • Receive closely-monitored medical treatment for Bipolar I Disorder for up to two and a half years.
  • Undergo initial lab work, an EKG if over age 40 and indicated, a psychiatric diagnostic evaluation, a review of your medical history, and a variety of clinical and psychological assessments.
  • Complete a variety of questionnaires assessing your symptoms and response to medication as part of your follow up (some of these may be done by phone),
  • Provide a small blood sample for DNA (gene) analysis.
  • Complete a 20-minute psychological test on two occasions.
  • Be prescribed lithium to treat your bipolar I disorder. Lithium is one of the most effective and best known medications for bipolar disorder and is considered standard of care. If you are not already taking lithium, you will be transitioned safely and slowly onto lithium monotherapy (that is, only lithium will be prescribed).
  • Need to take your medication as prescribed and keep your follow-up appointments.
  • Be paid for the research-related tasks that you complete, including self-report questionnaires, a diagnostic interview and having blood drawn for genetic analysis. Participants may be paid more than $400 over the course of the study.
  • Be responsible for payment for non-research parts of this study, including doctor’s visits, medication and lab work.


How to participate

If you are interested in participating in our research or simply want more information, contact Candice Schwebel, study coordinator, by phone or email.

University of Pennsylvania
Contact: Candice Schwebel
Study Coordinator 
Phone: 215-746-2736/215-573-4586
Fax: 215-573-2041
Email: candices@mail.med.upenn.edu 
Address: 125 South 31st Street, Room 2228
Philadelphia, PA 19104

 

Links

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