Deep Brain Stimulation for Refractory Major Depression

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Deep Brain Stimulation

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Deep Brain Stimulation, Treatment failure

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Health Network

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00296920

First Posted

February 23, 2006

Last Updated

February 16, 2009

Sponsor

University Health Network, Toronto

Collaborators

National Alliance for Research on Schizophrenia and Depression

1. Study Identification

Unique Protocol Identification Number

NCT00296920

Brief Title

Deep Brain Stimulation for Refractory Major Depression

Official Title

Deep Brain Stimulation for Refractory Major Depression

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Completed

Study Start Date

June 2002 (undefined)

Primary Completion Date

November 2007 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University Health Network, Toronto

Collaborators

National Alliance for Research on Schizophrenia and Depression

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

Deep Brain Stimulation, Treatment failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Deep Brain Stimulation

Primary Outcome Measure Information:

Title

Hamilton Rating Scale for Depression, 24-item version (HRSD-24)

Title

Clinical Global Impression (CGI) of Severity/Improvement

Title

Psychiatric assessments will be performed every two weeks in the clinic. Once final stimulation parameters are established, psychiatric symptoms will be monitored monthly.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andres Lozano, MD

Organizational Affiliation

University Health Network, Toronto

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sidney H Kennedy, MD, FRCPC

Organizational Affiliation

Univesity Health Network

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Health Network

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 2S8

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

15748841

Citation

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.

Results Reference

result

Major Depressive Disorder

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial