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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01801319
Recruitment Status : Unknown
Verified April 2017 by Abbott Medical Devices.
Recruitment status was:  Active, not recruiting
First Posted : February 28, 2013
Last Update Posted : April 26, 2017
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
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 or disease Intervention/treatment Phase
Treatment Resistant Depression Depressive Disorder Device: Libra Deep Brain Stimulation System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Clinical Evaluation of Subcallosal Cingulate Gyrus Deep Brain Stimulation for Treatment-Resistant Depression
Study Start Date : June 2011
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Primary Efficacy: Changes in the Hamilton Depression Rating Scale-17 [ Time Frame: 3 and 6 months ]
    evaluate change in HAMD-17 3 months and 6 months after implantation

Secondary Outcome Measures :
  1. The incidence of all adverse events [ Time Frame: 6 months ]
    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.

  2. Showing SCG-DBS significantly increases health related quality of life compared to sham stimulation in patients with TRD [ Time Frame: 6 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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): NCT01801319

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Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
Abbott Medical Devices
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Principal Investigator: Sidney Kennedy, M.D. Toronto General Hospital
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT01801319    
Other Study ID Numbers: C-08-07
Health Canada 148956 ( Other Identifier: Health Canada )
First Posted: February 28, 2013    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Keywords provided by Abbott Medical Devices:
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:
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Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders