Frequently Asked Questions

Answers to Your Questions

What is Major Depressive Disorder (MDD)?

What is being studied?

What is Brodmann Area 25?

How are patients selected?

Will my insurance pay for this?

What are the benefits of participating in this study?

What are the risks of participating in a clinical study?

What is the St. Jude Medical DBS System?

What will I have to do if I participate in the BROADEN study?

What time commitments will I need to make for the study?

How do I get in the BROADEN study?

What is Major Depressive Disorder (MDD)?
Major Depressive Disorder is defined as having a current major depressive episode or multiple depressive episodes.

The American Psychiatric Association defines a major depressive episode as a period of time during which there is either depressed mood or the loss of interest or pleasure in nearly all activities. The individual must also experience at least four additional symptoms of depression, including changes in

• Appetite or weight
• Insomnia
• Excessive sleepiness and psychomotor activity
• Decreased energy
• Feelings of worthlessness or guilt
• Difficulty thinking, concentrating, or making decisions
• Recurrent thoughts of death or thoughts of suicide, plans, or attempts

For these symptoms to be a major depressive episode, a symptom must either be new or must have clearly worsened when compared with the person’s pre-episode status. These symptoms must persist for most of the day, every day, for at least two consecutive weeks. The episode must also be accompanied by clinically significant distress or impairment in social, occupational, or other important areas of functioning.

A person in a major depressive episode often describes his or her mood as depressed, sad, hopeless, discouraged, or "down in the dumps."¹

What is being studied?
This study is investigating whether or not stimulating a structure in the brain known as Brodmann Area 25 with a deep brain stimulation (DBS) system is safe and effective for severe Major Depressive Disorder (MDD).

What is Brodmann Area 25?
Brodmann Area 25 (sometimes referred to as BA25) is an area of the brain. It is part of an area called the prefrontal cortex. Scientists have known for some time that it participates in networks that govern personal and social behavior, emotion, and decision making. A series of PET scans and neuroimaging experiments have demonstrated that this area of the brain is overactive during periods of profound negative mood (sadness).²

How are patients selected?
To produce the most reliable results, the BROADEN study has specific rules about who can participate and what procedures must be followed during the study. The doctors and nurses at the clinical study centers are familiar with these rules and will use them to determine if you meet the criteria to participate. Click here to learn more about some of the rules.

Will my insurance pay for this?
The device, surgical procedure, and study-related follow-up care will be provided at no cost.³

What are the benefits of participating in this study?
If you are selected to participate in the BROADEN Study, you will

• Contribute to the understanding of deep brain stimulation for major depressive disorder
• Work with a psychiatrist and team of healthcare professionals that have experience with DBS
• Possibly help yourself and others by increasing the medical community's knowledge about depression
• Receive study-related care from medical professionals during your participation at no cost³

What are the risks of participating in a clinical study?
Clinical studies are designed to evaluate the safety and effectiveness of investigational drugs and devices. All clinical studies involve some risk.

All potential participants will be given an informed consent form, which provides detailed information about the study procedures, risks, and potential benefits.  Doctors and nurses are available at each center to answer all of your questions before you make your decision to participate in the study.

Only doctors with experience in treating severe depression and surgical teams with DBS experience have been selected for this study.

What is the St. Jude Medical DBS System?
The St. Jude Medical DBS system is a family of devices that will be used in the BROADEN Study. The devices in the system are designed to work together to stimulate the brain.  The system looks and operates much like a pacemaker, except that instead of sending pulses of current to the heart, it sends pulses to small, targeted areas in the brain.

The St. Jude Medical system includes a neurostimulator, leads, and extensions that are surgically implanted. Images of the system can be found here.

In addition to the implanted components, the system includes a programmer and a controller, which are not implanted. The programmer is used to customize the stimulation produced by the neurostimulator. The controller is used to turn the neurostimulator on and off.

What will I have to do if I participate in the BROADEN study?
If you participate in the BROADEN study, you will be examined by several members of the clinical study team, including a psychiatrist and neuropsychologist to determine if you meet the requirements to participate in this study. You will also be examined by a neurosurgeon to see if there are any reasons why you should not have the surgery.

If you meet all of the requirements, a study team member will be assigned to you to contact you periodically between study visits; helping you through the study.

You will undergo surgery to receive a St. Jude Medical DBS system. After surgery, you will visit your study psychiatrist a total of 14 times through the remainder of the study.

What time commitments will I need to make for the study?
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.

How do I get in the BROADEN study?
Contact the BROADEN Call Center at 877-788-3916. They will collect some basic information about your medical history and send it to a study center. The staff at the study center will then contact you to discuss your candidacy for this study.

¹ American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, 4th ed., Text Revision, Washington, D.C.: American Psychiatric Association; 2000.

²Reciprocal limbic-cortical function and negative mood: converging PET findings in depression and normal sadness. Mayberg HS, Liotti M, Brannan SK, McGinnis S, Mahurin RK, Jerabek PA, Silva JA, Tekell JL, Martin CC, Lancaster JL, Fox PT. Am J Psychiatry. 1999;156(5):675-682.

³ See informed consent form, a separate a document, for details.