- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00296920
Deep Brain Stimulation for Refractory Major Depression
February 16, 2009 updated by: University Health Network, Toronto
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 with a minimum four major depressive episodes, (iv) current episode duration of no less than twelve months; (v) current episode treatment failure to a minimum of four treatment classes-including serotonin-reuptake inhibitors (SSRI), other novel agents, monoamine oxidase inhibitors (MAOI), tricyclics; somatic treatments such as ECT or vagus nerve stimulation (VNS); some form of psychotherapy.
Exclusion criteria (i) previous brain surgery (ii) neurological disorder of any type, (iii) significant psychiatric comorbidity as defined by DSM IV diagnostic criteria (such as schizophrenia, panic disorder) (iv) serious medical conditions or contraindication for surgery such as cardiac pacemaker/defibrillator or other implanted devices.
Full medical records from a treating psychiatrist will first be reviewed by Dr. Kennedy.
Eligible patients will then undergo a full psychiatric, neurological and neuropsychological evaluation (Appendix 1 and 2).
Final selection will be made by consensus of the investigative team in collaboration with a senior independent psychiatrist Robert Cooke, MD with expertise in intractable mood disorders.
Informed consent will be obtained prior to entering the study.
Study Type
Interventional
Enrollment
10
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ontario
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Toronto, Ontario, Canada, M5T 2S8
- University Health Network
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Hamilton Rating Scale for Depression, 24-item version (HRSD-24)
|
Clinical Global Impression (CGI) of Severity/Improvement
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Psychiatric assessments will be performed every two weeks in the clinic. Once final stimulation parameters are established, psychiatric symptoms will be monitored monthly.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Andres Lozano, MD, University Health Network, Toronto
- Principal Investigator: Sidney H Kennedy, MD, FRCPC, Univesity Health Network
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2002
Primary Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
February 23, 2006
First Submitted That Met QC Criteria
February 23, 2006
First Posted (Estimate)
February 27, 2006
Study Record Updates
Last Update Posted (Estimate)
February 17, 2009
Last Update Submitted That Met QC Criteria
February 16, 2009
Last Verified
September 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02-0118-B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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