NCT00296920

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 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_3 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Last Updated

February 17, 2009

Status Verified

September 1, 2005

Enrollment Period

5.4 years

First QC Date

February 23, 2006

Last Update Submit

February 16, 2009

Conditions

Major Depressive Disorder

Keywords

Deep Brain StimulationTreatment failure

Outcome Measures

Primary Outcomes (3)

  • 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.

Interventions

Deep Brain StimulationDEVICE

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (1)

  • 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. doi: 10.1016/j.neuron.2005.02.014.

    PMID: 15748841RESULT

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Andres Lozano, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

  • Sidney H Kennedy, MD, FRCPC

    Univesity Health Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 23, 2006

First Posted

February 27, 2006

Study Start

June 1, 2002

Primary Completion

November 1, 2007

Last Updated

February 17, 2009

Record last verified: 2005-09

Locations

CA(1)