Deep Brain Stimulation for Refractory Major Depression
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ClinicalTrials.gov Identifier: NCT00296920 |
Recruitment Status :
Completed
First Posted : February 27, 2006
Last Update Posted : February 17, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Major Depressive Disorder | Device: Deep Brain Stimulation | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 10 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Deep Brain Stimulation for Refractory Major Depression |
Study Start Date : | June 2002 |
Actual Primary Completion Date : | November 2007 |

- Hamilton Rating Scale for Depression, 24-item version (HRSD-24)
- Clinical Global Impression (CGI) of Severity/Improvement
- 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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Ages Eligible for Study: | 30 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00296920
Canada, Ontario | |
University Health Network | |
Toronto, Ontario, Canada, M5T 2S8 |
Principal Investigator: | Andres Lozano, MD | University Health Network, Toronto | |
Principal Investigator: | Sidney H Kennedy, MD, FRCPC | Univesity Health Network |
ClinicalTrials.gov Identifier: | NCT00296920 |
Other Study ID Numbers: |
02-0118-B |
First Posted: | February 27, 2006 Key Record Dates |
Last Update Posted: | February 17, 2009 |
Last Verified: | September 2005 |
Deep Brain Stimulation Treatment failure |
Depressive Disorder Depressive Disorder, Major Mood Disorders Mental Disorders |