A Clinical Evaluation of Subcallosal Cingulate Gyrus Deep Brain Stimulation for Treatment-Resistant Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01801319
First received: February 26, 2013
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

This is a randomized, placebo-controlled double-blind cross-over trial evaluating the safety, efficacy, daily functioning, and health-related quality of life of Subcallosal Cingulate Gyrus Deep Brain Stimulation (SCG DBS) for participants with Treatment-Resistant Depression (TRD). A total of 40 eligible participants will be randomized to four treatment sequences (10 participants per sequence). Each participant will be treated over a 6-month period with active or sham stimulation in which both the participants and the attending psychiatrists will be blinded to treatment allocation.


Condition Intervention
Treatment Resistant Depression
Depressive Disorder
Device: Libra Deep Brain Stimulation System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Clinical Evaluation of Subcallosal Cingulate Gyrus Deep Brain Stimulation for Treatment-Resistant Depression

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Primary Efficacy: Changes in the Hamilton Depression Rating Scale-17 [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    evaluate change in HAMD-17 3 months and 6 months after implantation


Secondary Outcome Measures:
  • The incidence of all adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The incidence of all adverse events (i.e. hospitalization due to worsening depression, suicidal ideation, or behavior, medical treatment, and device related events) that occur over study duration.

  • Showing SCG-DBS significantly increases health related quality of life compared to sham stimulation in patients with TRD [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The following health related quality of life measures will be evaluated: Sheehan Disability Scale-Visual Analog Scale (SDS-VAS), Short Form-12 (SF-12), Sexual Functioning questionnaire (SEX FX) and Endicott Work Productivity Scale (EWPS). Each measure will be evaluated at baseline and the after each treatment period.


Estimated Enrollment: 40
Study Start Date: June 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Stimulation
Libra Deep Brain Stimulation System is implanted and activated post implantation
Device: Libra Deep Brain Stimulation System
Sham Comparator: No Stimulation
The Libra DBS System is implanted and not activated
Device: Libra Deep Brain Stimulation System

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women (non-pregnant) ages 21-70 years;
  2. Diagnosed with non-psychotic major depressive disorder, single or recurrent episode by DSM-IV-TR criteria;
  3. First episode onset before age 45;
  4. Current episode > 12 months duration;
  5. In the current episode: Documented resistance (i.e. persistence of the major depressive episode) to a minimum of 4 adequate depression treatments from at least 3 different treatment categories (e.g. SSRI's, SNRI's, TCA's, MAO-inhibitors, Mirtazipine, Nefazodone, Trazodone, Bupropion, lithium augmentation, thyroid augmentation, ECT); Adequacy of treatments as defined by a score of at least 3 according to the amended Antidepressant Treatment History Form (ATHF) criteria;
  6. Hamilton Depression Rating Scale (HDRS) of > 20 at 3 separate baseline visits, rated by 2 separate psychiatrists, Baseline 2 and Baseline 3 HDRS scores cannot improve ≥ 25%;

Exclusion Criteria:

  1. A diagnosis of a bipolar I or bipolar II disorder by DSM-IV-TR criteria;
  2. Meets criteria for borderline or antisocial personality disorder in the last 12 months by DSM-IV-TR criteria, derived from the Cluster B Personality.
  3. In the current depressive episode, has been diagnosed with General Anxiety Disorder (GAD) - as defined by the DSM-IV-TR, and GAD is the primary diagnosis;
  4. Has an intracranial Central Nervous System (CNS) disease that impairs motor, sensory or cognitive function or that requires intermittent or chronic medication (e.g., Parkinson's Disease, migraine, stroke, Huntington's, head trauma, etc.) with exception to non-migraine headaches;
  5. Has been diagnosed with fibromyalgia or has a current condition which requires chronic pain narcotic usage (e.g. morphine, methadone);
  6. Has been currently diagnosed with chronic fatigue syndrome;
  7. Substantial suicidal risk as defined by (1) a current plan and intent, (2) clinician judgment that there is a clear immediate intent for self-harm, (3) more than 3 suicide attempts within the last 12 months;
  8. Co-morbid obsessive compulsive disorder, post-traumatic stress disorder, panic disorder, bulimia or anorexia nervosa if previously present, must be in remission for 6 months as defined by DSM-IV-TR criteria, derived from the MINI;
  9. Alcohol, medication, or illegal substance dependence within last 12 months;
  10. Advanced cardiovascular disease which renders anesthesia and surgery as unsafe as determined by neurosurgeon;
  11. Plans to use diathermy;
  12. Have any metallic implants in the brain such as aneurysm clips or cochlear implants;
  13. Currently participating in another investigational device, drug or surgical trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01801319

Contacts
Contact: Sakina Rizvi 416-340-3466 Sakina.Rizvi@uhn.on.ca

Locations
Canada, Ontario
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Principal Investigator: Sidney Kennedy, M.D.         
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Sidney Kennedy, M.D. Toronto General Hospital
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01801319     History of Changes
Other Study ID Numbers: C-08-07, Health Canada 148956
Study First Received: February 26, 2013
Last Updated: March 1, 2013
Health Authority: Canada: Health Canada

Keywords provided by St. Jude Medical:
major depressive disorder (MDD)
deep brain stimulation (DBS)
subcallosal cingulate gyrus
Therapy-Resistant Depression
Electrical Stimulation of the Brain
Brain Stimulation, Deep

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014