Purpose

This is a prospective, controlled, multi-center, double blind, randomized study to evaluate deep brain stimulation (DBS) as a treatment for major depression. Despite the available medications and psychotherapy treatments, a large number of depressed patients do not have an acceptable or sustained response. Fewer than half of these patients achieve remission, and up to one in five (20%) develop treatment resistant depression. Unfortunately, there are a limited number of new treatment options for treatment resistant patient population. DBS is a surgical implant that has shown promise in the treatment of severe, treatment resistant depression. In a recent study (Mayberg et. al. 2005), a small group of severe refractory depressed patients received DBS of a specific region in the front of the brain (referred to as Brodmann Area 25). DBS induced clinical response in 4 out of 6 patients, with 2 patients achieving full remission. These preliminary findings are promising, but much larger, controlled clinical trials are necessary to test the safety and efficacy of DBS in the treatment of depression. From up to 20 investigational sites, 201 patients (15 at NYSPI/Columbia) with major depressive disorder who have failed at least four treatments in the current episode will be implanted with DBS. Two thirds of the patients will have their DBS activated after recovery from surgery (called the “active” group), while the remaining third will not have their DBS turned on for the first 6 months of the 12-month study (called the “control” group). All patients will continue their medications, but the dosages of medications for depression will be held steady during the first 6 months. The goal is to evaluate the safety and efficacy of DBS to Brodmann Area 25 as an add-on to conventional therapy in the treatment of resistant depression.

Type of Study: Clinical Trial
Setting of Study: both
Clinical Trials.gov number: 
Providing Clinical Treatment?: Yes
No Cost Treatment?: Yes
Care is provided in languages: English

Study Activities

Filling Out Forms
Blood Samples
MRI Scan

Eligibility

Ages Eligible for Study: 21 Years - 70 Years
Genders Eligible for Study: Both
This study is not recruiting Healthy Volunteers.

Criteria

Inclusion Criteria:
Age 21-70.
Diagnosis of non-psychotic unipolar major depressive disorder, single or recurrent episode.
First episode of MDD onset before age 45, current episode must be > 12 months duration.
In the current episode there must have documented resistance to a minimum of four adequate depression treatments from three different treatment categories within the past five years. At least three failed treatment trials must have taken place as an adult (since age 18). At least one of the failed trials must have taken place within the past year.
Prior failure to at least two combined drug treatments (e.g. anti-depressant plus mood stabilizer or other adjunctive medication, two antidepressants, etc).
Prior failure or refusal of an MAO-inhibitor.
Received a course of psychotherapy of known efficacy for depression in lifetime.
Prior failure, intolerance, or refusal of ECT, or relapse after undergoing ECT.
Must be able to give informed consent.
Must be determined medically stable to undergo deep brain stimulation procedure.
If female, must not be lactating, and, if of child bearing potential, must not have a positive pregnancy test and must be using adequate contraception.


Links
study website

Location: 1051 Riverside Dr., Unit 21, Rm 5100 New York,NY10032
Clinic: 
Division: Other

Study chairs or principal investigators:
Sarah Hollingsworth Lisanby M.D., Principal Investigator

Co-investigators:
Robert Goodman,
Guy McKhann,
Stefan Rowny,
Peter Bulow,
Arielle Stanford