Depression Clinical Trial
Official title:
Reclaim Deep Brain Stimulation Clinical Study for Treatment-Resistant Depression
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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