Deep Brain Stimulation (DBS) for Treatment-Resistant Depression (TRD)
Condition: Treatment Resistant Depression; Depressive Disorder, Treatment-Resistant; Depression, Bipolar
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant; Bipolar Disorder
Study type: Interventional

Summary: 
      In this pilot study, we propose 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.
    

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 we 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.
    

Intervention name(s): SCC DBS
Intervention type(s): Device
Intervention description(s): Deep Brain Stimulator
Other intervention name(s): Libra(TM) Implantable Deep Brain Stimulation (DBS) System
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Treatment Resistant Depression; Treatment Refractory Depression; Treatment Resistant Bipolar Disorder; Treatment Refractory Bipolar Disorder; Deep brain stimulation; DBS