Major Depressive Disorder Clinical Trial
Official title:
Deep Brain Stimulation for Refractory Major Depression
NCT number | NCT00296920 |
Other study ID # | 02-0118-B |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | February 23, 2006 |
Last updated | February 16, 2009 |
Start date | June 2002 |
Verified date | September 2005 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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 are available where brain lesions are made that interrupt white matter tracts linking orbital frontal cortex to the striatum, resulting in significant therapeutic benefit for many patients. In this study, we will test the safety and efficacy of Deep Brain Stimulation (DBS)--a reversible method used to modulate brain activity--as an alternative to the standard subcaudate tractotomy (SCT). The physiological consequences of this procedure will be mapped longitudinally using positron emission tomography (PET) measures of brain glucose metabolism. Patients will be clinically monitored for 1 year with longitudinal psychiatric, neurological, neurosurgical, neuropsychological and PET imaging examinations to assess treatment efficacy and side effects.
Status | Completed |
Enrollment | 10 |
Est. completion date | |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | National Alliance for Research on Schizophrenia and Depression |
Canada,
Mayberg HS, Lozano AM, Voon V, McNeely HE, Seminowicz D, Hamani C, Schwalb JM, Kennedy SH. Deep brain stimulation for treatment-resistant depression. Neuron. 2005 Mar 3;45(5):651-60. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hamilton Rating Scale for Depression, 24-item version (HRSD-24) | |||
Primary | Clinical Global Impression (CGI) of Severity/Improvement | |||
Primary | Psychiatric assessments will be performed every two weeks in the clinic. Once final stimulation parameters are established, psychiatric symptoms will be monitored monthly. |
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