Reclaim Deep Brain Stimulation Clinical Study for Treatment-Resistant Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Intervention: Reclaim™ DBS System
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment Resistant Depression; Treatment Refractory Depression; Deep Brain Stimulation; Depression

Summary:

      Medtronic, Inc. sponsored an investigational study of the Reclaim™ Deep Brain Stimulation
      (DBS) System in people that have treatment-resistant depression. Depression is a mood
      disorder and a serious medical condition that affects millions of Americans. Depressive
      symptoms may include loss of interest in things typically enjoyed; decreased energy levels;
      difficulty concentrating or making decisions; restlessness; and feelings of pessimism,
      hopelessness, and worthlessness. Treatment-resistant depression is a chronic and severe form
      of depression characterized by failure to respond to traditional forms of treatment, such as
      antidepressant medications and electroconvulsive therapy. Treatment-resistant depression
      significantly impacts quality of life, productivity, and is a major contributor of disability
      world-wide.

      This randomized, double-blind, sham stimulation-controlled, multi-center, prospective,
      parallel design study used deep brain stimulation technology to test whether active bilateral
      stimulation can safely and effectively improve depressive symptoms in patients with
      treatment-resistant depression compared to sham stimulation.

      Participants meeting criteria for the study were implanted with the Reclaim DBS System.
      Participants in the active group, who received active stimulation, were compared to the
      control group, who received sham stimulation, during the 16-week blinded-treatment phase. All
      participants were monitored for changes in depressive symptoms. After the blinded-treatment
      phase, all participants received active stimulation.

      Candidates for the trial were adults who had major depressive disorder and had not responded
      to several treatments for depression. Participants in the study continued to receive their
      current antidepressant medications while participating in the trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Consent to participate in screening and study procedures by signing and dating the
             Informed Consent Form

          -  Are diagnosed with major depressive disorder (MDD)

          -  Have tried at least 4 different treatments, for example antidepressant medications,
             combinations of antidepressant medications, and/or electroconvulsive therapy (ECT)

          -  Screening MADRS score ≥ 28

          -  Have had the current major depressive episode persist for at least 2 years

          -  Females, if of child-bearing potential, must be using an acceptable method of birth
             control

        Exclusion Criteria:

          -  Females: Currently pregnant

          -  Currently enrolled in or plan to enroll in any concurrent drug and/or device study
             that may confound the results of this study

          -  Have a neurological condition that may jeopardize the safety or the conduct of the
             study

          -  Have any medical conditions unsuitable for undergoing DBS surgery