Status:
COMPLETED
Deep Brain Stimulation (DBS) for Treatment-Resistant Depression (TRD)
Lead Sponsor:
Paul Holtzheimer
Conditions:
Treatment Resistant Depression
Depressive Disorder, Treatment-Resistant
Eligibility:
All Genders
22-70 years
Phase:
NA
Brief Summary
In this pilot study, we propose to test whether high frequency stimulation of the subcallosal cingulate (SCC) is a safe and efficacious antidepressant treatment in five TRD patients, to compare the ef...
Detailed Description
The U.S. lifetime prevalence of major depressive disorder (MDD) is 17%. A number of treatments are available for depression including medications, psychotherapy and various somatic treatments. Unfortu...
Eligibility Criteria
Inclusion
- A partial list of eligibility criteria includes:
- Age 18-70 years old
- Ability to provide written informed consent
- Current Major Depressive Episode (MDE), secondary to either Major Depressive Disorder or Bipolar Disorder (I, II or NOS)
- A current depressive episode of at least 12 months duration
- For patients with a bipolar disorder, the last hypomanic or manic episode must have been at least 2 years before study entry
- A maximum Global Assessment of Functioning of 50
- Able to tolerate general anesthesia, DBS surgery and MRI scans
- No significant cerebrovascular risk factors or a previous stroke, documented major head trauma or neurodegenerative disorder
- No currently active clinically significant Axis I psychiatric diagnosis or a personality disorder likely to interfere with the study
- No evidence of global cognitive impairment
- Lives locally or willing to relocate to the area for up to One Year
Exclusion
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01898429
Start Date
July 1 2013
End Date
December 1 2016
Last Update
July 25 2019
Active Locations (1)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756