Reclaim Deep Brain Stimulation Clinical Study for Treatment-Resistant Depression

Study Overview
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Brief Summary
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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.

Official Title
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Reclaim Deep Brain Stimulation Clinical Study for Treatment-Resistant Depression

Conditions
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Depression

Intervention / Treatment
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* Device: Reclaim™ DBS System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Group - Active Stimulation<br>Receive active stimulation with Reclaim™ DBS System | Device: Reclaim™ DBS System<br> <br> |
| Sham Comparator: Control Group - Sham Stimulation<br>Receive sham stimulation with Reclaim™ DBS System | Device: Reclaim™ DBS System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responders | Montgomery-Åsberg Depression Rating Scale (MADRS); total score can range from 0 (no symptoms) to 60 (severe depression). Response is defined as at least a 50% improvement (decline) in MADRS score. Responder rate is the proportion of participants who experience response. | Baseline to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression Change | Montgomery-Åsberg Depression Rating Scale (MADRS); total score can range from 0 (no symptoms) to 60 (severe depression). Improvement is measured by the groups' mean percent change in MADRS score. An improvement is represented by a decline in MADRS (a negative percent change). | Baseline to 16 weeks | 
| Quality of Life Change | Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF); total score can range from 0 to 100 with higher scores indicating a better quality of life. Improvement is measured by the groups' mean change in Q-LES-Q-SF score. An improvement is represented by an increase in Q-LES-Q-SF (a positive change). | Baseline to 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment Resistant Depression, Treatment Refractory Depression, Deep Brain Stimulation, Depression