Status:
COMPLETED
Deep Brain Stimulation for Refractory Major Depression
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
National Alliance for Research on Schizophrenia and Depression
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
30-70 years
Phase:
PHASE3
Brief Summary
Despite many available treatments, there are patients with major depression who remain treatment refractory and chronically disabled. For these severely ill patients, several neurosurgical procedures ...
Detailed Description
Study Design Subjects: Ten patients will be enrolled in this pilot study. Eligibility criteria: (i) age 30-70 years old, (ii) diagnosis of refractory unipolar major depression, (iii) recurrent illness...
Eligibility Criteria
Inclusion
- Age 30-70; men and women (non-pregnant)
- Diagnosis: major depressive episode (unipolar) by DSM-IV derived from the SCID-P.
- Recurrent disease; minimum 4 major depressive episodes .
- Chronic illness with current episode \~ 12 months duration
- Response failure to multiple treatment regimens. Resistance or intolerance to at least four treatments from different categories (SSRI, SNRI, TCA, HCA, MAOI, atypical, Lithium, anticonvulsants, ECT, VNS, CBT/IPT). Documentation of adequate dose and duration of each treatment.
- Hamilton Rating Scale for Depression (HRSD-24) score \>20
- Global Assessment of Function. score \~50
- No neurological disease; no other Axis 1 or Axis II diagnosis; no substance abuse
- Stable on current antidepressant meditation regimen or medication free \~4 weeks
- Able to give informed consent in accordance with institutional policies.
- Able to comply with all testing and follow-up visit requirements defined by the Study Protocol. Pre-menopausal women must agree to use acceptable methods of birth control (radiation risk of PET)
Exclusion
- Atypical or psychotic subtypes of major depressive disorder.
- Alcohol or substance dependence within 12 months; abuse within 6 months, excluding nicotine Current suicidal ideations, plan or intent for self-harm; in past 3 years, repeated suicide attempts, resulting in emergency room or inpatient care.
- Major medical illness, cardiac pacemaker/defibrillator, and other implanted stimulator.
- Likely to relocate or move to a location distant from the study site within one year of enrollment
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00296920
Start Date
June 1 2002
Last Update
February 17 2009
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5T 2S8