Status:
TERMINATED
Long Term Follow-up of Deep Brain Stimulation for Treatment-Resistant Depression
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Conditions:
Treatment Resistant Depression
Depressive Disorder, Treatment-Resistant
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The long term follow up of a pilot study in which the investigators proposed to test whether high frequency stimulation of the subcallosal cingulate (SCC) is a safe and efficacious antidepressant trea...
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
- Have received DBS for TRD
- Ability to provide written informed consent
- Willing to comply with all necessary study visits
Exclusion
- Significant cerebrovascular risk factors or a previous stroke, documented major head trauma or neurodegenerative disorder.
- Other currently active clinically significant Axis I psychiatric diagnosis including schizophrenia, panic disorder, obsessive-compulsive disorder, generalized anxiety disorder or post-traumatic stress disorder. Patients with severe Axis II personality disorders will also be excluded if the personality disorder is likely to interfere with cooperation and adherence to the study protocol.
- Current psychotic symptoms.
- Evidence of global cognitive impairment.
- Substance abuse or dependence not in full sustained remission (i.e., not active for at least one year).
- Active suicidal ideation with intent; suicide attempt within the last six months; more than three suicide attempts within the last two years.
- Pregnancy or plan to become pregnant during the study period.
- General contraindications for DBS surgery (cardiac pacemaker/defibrillator or other implanted devices).
- Inability or unwillingness to comply with long-term follow-up.
- History of intolerance to neural stimulation of any area of the body.
- Participation in another drug, device or biologics trial within the preceding 30 days.
- Conditions requiring repeated MRI scans.
- Conditions requiring diathermy.
- Conditions requiring anticoagulant medication.
- Terminal illness associated with expected survival of \<12 months.
Key Trial Info
Start Date :
April 18 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03360942
Start Date
April 18 2016
End Date
September 30 2022
Last Update
December 12 2024
Active Locations (1)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766