Reclaim Deep Brain Stimulation Clinical Study for Treatment-Resistant Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00837486
First received: February 3, 2009
Last updated: May 6, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention Phase
Depression
Device: Reclaim™ DBS System
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reclaim Deep Brain Stimulation Clinical Study for Treatment-Resistant Depression

Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:
  • Responders [ Time Frame: Baseline to 16 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Depression Change [ Time Frame: Baseline to 16 weeks ] [ Designated as safety issue: No ]
    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).

  • Quality of Life Change [ Time Frame: Baseline to 16 weeks ] [ Designated as safety issue: No ]
    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).


Other Outcome Measures:
  • Long-term Open-label Responders [ Time Frame: at the 24-month visit ] [ Designated as safety issue: No ]
    This measure is for long-term, open-label stimulation. Response is defined as at least a 50% improvement (decline) in MADRS score. Responder rate is the proportion of participants who experience response. All enrolled participants are included in the analysis, even if they withdrew early. Participants that withdrew early are counted as non-responders.

  • Therapy-related Adverse Events [ Time Frame: from enrollment to study closure (average follow-up of 36 months) ] [ Designated as safety issue: Yes ]
    Adverse events related to the device, implant procedure, and/or stimulation are reported. Events with a prevalence of greater than 5% of subjects are reported. This measure describes the experience of all study participants (both Active and Control Groups combined), and includes the operative, blinded-treatment,and the long-term open-label follow-up phases combined. Active Group participants began therapy after randomization, while Control Group participants began therapy after 16 weeks of sham stimulation.


Enrollment: 30
Study Start Date: February 2009
Study Completion Date: April 2013
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Group - Active Stimulation
Receive active stimulation with Reclaim™ DBS System
Device: Reclaim™ DBS System
Sham Comparator: Control Group - Sham Stimulation
Receive sham stimulation with Reclaim™ DBS System
Device: Reclaim™ DBS System

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837486

Locations
United States, Massachusetts
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
MedtronicNeuro
  More Information

Publications:
Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT00837486     History of Changes
Other Study ID Numbers: 1626, G080033
Study First Received: February 3, 2009
Results First Received: March 13, 2015
Last Updated: May 6, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by MedtronicNeuro:
Treatment Resistant Depression
Treatment Refractory Depression
Deep Brain Stimulation
Depression

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

ClinicalTrials.gov processed this record on July 29, 2015