Long Term Follow-up of 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. Identifier: NCT03360942
Recruitment Status : Active, not recruiting
First Posted : December 4, 2017
Last Update Posted : August 15, 2018
Information provided by (Responsible Party):
Paul Holtzheimer, Dartmouth-Hitchcock Medical Center

Brief Summary:
The long term follow up of a pilot study in which the invesitagors proposed to test whether high frequency stimulation of the subcallosal cingulate (SCC) is a safe and efficacious antidepressant treatment in five TRD patients, to compare the effects of left-sided vs. right-sided stimulation, and to investigate potential mechanisms of action of this intervention. Importantly, this study will be used to assess the need for and assist in planning a larger, more definitive trial of SCC DBS for TRD.

Condition or disease Intervention/treatment
Treatment Resistant Depression Depressive Disorder, Treatment-Resistant Depression, Bipolar Device: SCC DBS

Detailed Description:

The U.S. lifetime prevalence of major depressive disorder (MDD) is 17%. A number of treatments are available for depression including medications, psychotherapy and various somatic treatments. Unfortunately, up to two-thirds of patients remain symptomatic following first-line treatment and a third fail to achieve remission (defined as full resolution of depressive symptoms) after four established treatments; approximately 10%-20% of depressed patients may show virtually no improvement despite multiple, often aggressive treatments. Thus, a conservative estimate places the U.S. prevalence of treatment-resistant depression (TRD) at 1%-3%. TRD has a high risk of suicide, is a major cause of disability and is responsible for doubling of overall health care costs.

For patients with TRD there are limited evidence-based treatment options. Transcranial magnetic stimulation (TMS) may have efficacy for patients that have failed no more than one antidepressant medication 10-12, but response and remission rates are relatively low (under 30% and 20% respectively). Vagus nerve stimulation (VNS) may have efficacy in patients that have failed 4-6 antidepressant treatments but long-term response and remission rates are again low (about 20% and 10% respectively). Electroconvulsive therapy(ECT) can be effective in TRD patients with remission rates of 50%-60%. However, more than 70% of TRD patients will relapse within 6 months following a successful acute treatment course. For patients that have failed ECT, there are no evidence-based treatment options. Therefore, there is great need for novel treatment approaches for TRD.

Prior clinical trials have shown that SCC DBS has the potential to be a valuable treatment option for patients with TRD. Further developing this treatment will involve confirming its effectiveness and identifying ways to optimize its use. In this study the investigators intend to test the safety and efficacy of chronic SCC DBS as a treatment for TRD and compare the safety and efficacy of left-sided versus right-sided stimulation using a double-blind, randomized, cross-over design.

Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Long Term Follow-up of Deep Brain Stimulation for Treatment-Resistant Depression
Actual Study Start Date : April 18, 2016
Estimated Primary Completion Date : November 22, 2026
Estimated Study Completion Date : November 22, 2028

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
DBS Long Term Follow Up
5 participants who were in a prior study to receive DBS are enrolled to have their progress and DBS devices monitored for a period of 12 years.
Device: SCC DBS
Deep Brain Stimulator
Other Name: Libra(TM) Implantable Deep Brain Stimulation (DBS) System

Primary Outcome Measures :
  1. Depressive symptoms measured by the 17-item Hamilton Depression Rating [ Time Frame: Change from baseline Hamilton-17 score to follow-up visits at 1, 3, 6, 9, 12, 18, and 24 months after initial DBS treatment ]
    Depressive symptoms will be measured by the 17-item Hamilton Depression Rating Scale.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are enrolled in the DBS for TRD study at DHMC will be given the opportunity to enroll in the ten year follow-up study at the end of the DBS for TRD study in which they are currently enrolled. Patients will be informed of the option during the screening phase of the DBS for TRD study as well as a reminder 2 weeks prior to completion of the study. A total of five (5) patients will be enrolled in this study

Inclusion Criteria:

  • Have received DBS for TRD
  • Ability to provide written informed consent
  • Willing to comply with all necessary study visits

Exclusion Criteria:

  • Significant cerebrovascular risk factors or a previous stroke, documented major head trauma or neurodegenerative disorder.
  • Other currently active clinically significant Axis I psychiatric diagnosis including schizophrenia, panic disorder, obsessive-compulsive disorder, generalized anxiety disorder or post-traumatic stress disorder. Patients with severe Axis II personality disorders will also be excluded if the personality disorder is likely to interfere with cooperation and adherence to the study protocol.
  • Current psychotic symptoms.
  • Evidence of global cognitive impairment.
  • Substance abuse or dependence not in full sustained remission (i.e., not active for at least one year).
  • Active suicidal ideation with intent; suicide attempt within the last six months; more than three suicide attempts within the last two years.
  • Pregnancy or plan to become pregnant during the study period.
  • General contraindications for DBS surgery (cardiac pacemaker/defibrillator or other implanted devices).
  • Inability or unwillingness to comply with long-term follow-up.
  • History of intolerance to neural stimulation of any area of the body.
  • Participation in another drug, device or biologics trial within the preceding 30 days.
  • Conditions requiring repeated MRI scans.
  • Conditions requiring diathermy.
  • Conditions requiring anticoagulant medication.
  • Terminal illness associated with expected survival of <12 months.

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 identifier (NCT number): NCT03360942

United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766
Sponsors and Collaborators
Paul Holtzheimer

Responsible Party: Paul Holtzheimer, Deputy Director for Research at the National Center for PTSD, Associate Professor at Dartmouth/Dartmouth Hitchcock., Dartmouth-Hitchcock Medical Center Identifier: NCT03360942     History of Changes
Other Study ID Numbers: D12131
23442 ( Other Identifier: Dartmouth Committee for the Protection of Human Subjects )
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

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