About the BROADEN Clinical Study
 

The BROADEN (BROdmann Area 25 DEep brain Neuromodulation) study will evaluate the safety and effectiveness of deep brain stimulation in patients with severe depression who have not responded to multiple treatments. Stimulation to the brain is provided by a neurosurgically implanted medical device called a deep brain stimulation (DBS) system. The DBS system provides stimulation directly to a focused area of the brain known as Brodmann Area 25 (sometimes referred to as BA25). The study will build upon the depression work of a research team from the University of Toronto, led by neurologist Helen S. Mayberg, M.D. and neurosurgeon Andres Lozano, M.D., PhD, FRCSC.

Participants in this study must

• Meet the inclusion criteria
• Have surgery to have the DBS system implanted
• Be available for follow-up visits

Participants should continue to take their current medications and participate in counseling during this study, but their psychiatric care must be transferred to the clinical study team for the duration of the study. Participants will receive the device, the surgical procedure, and study-related follow-up care free of charge. See the informed consent form, a separate document, for details.

Do I Qualify?

The BROADEN study has specific rules about who can participate, how many can participate, and what procedures must be followed during the study.

You may be able to participate if you

• Have been diagnosed with Major Depressive Disorder (MDD)
• Are between 21 and 70 years old
• Had your first depressive episode before age 45
• Have tried at least four treatments in your current episode. For example
  • Medications such as Zoloft^®, Prozac^®, Lexapro^®, Wellbutrin^®, Paxil^®, Effexor^®, Cymbalta^®, and combinations of these or other medications
  • Psychotherapy, cognitive behavioral therapy (CBT), or other talk therapies
  • Vagus nerve stimulation (VNS) or transcranial magnetic stimulation (TMS or rTMS)
  • Electroconvulsive therapy (ECT)
• Are open to considering a surgical option for your depression
• Are willing to get copies of your records for the last few years from your psychiatrist
• Are available for follow-up visits for at least 12 months
• Are willing to transfer your primary psychiatric care to the psychiatrist conducting this study

If you meet these criteria and would like more information, contact the clinical study call center toll-free at 877-788-3916.

Study Time Commitment

Participants should consider the study time commitments and their ability to see the study doctors as required before agreeing to participate.

The study visits include

• Three initial visits. The first of these visits takes about 6 to 7 hours. The remaining two visits will take about 1 to 2 hours each. After the third visit, there will also be a visit with the neurosurgeon and some pre-surgical testing and imaging.
• About two days in the hospital to have the device implanted.
• After the device is implanted, study participants will visit the study psychiatrist twice a month for the two months following surgery.
• Beginning three months after surgery, participants will make monthly visits to the study psychiatrist. Most of these visits will take about 1 to 2 hours. The study participant should expect to spend 4 to 6 hours with the study psychiatrist for the visits at 6 and 12 months after surgery.

*In addition to surgery, there is usually one visit to the neurosurgeon prior to surgery and one follow-up visit after surgery.

Effexor is a registered trademark of Wyeth Pharmaceuticals; Cymbalta and Prozac are registered trademarks of Eli Lilly and Company; Lexapro is a registered trademark of Forest Pharmaceuticals, Inc; Paxil and Wellbutrin are registered trademarks of GlaxoSmithKline; Zoloft is a registered trademark of Pfizer Inc.