Reclaim Deep Brain Stimulation Clinical Study for Treatment-Resistant Depression
2 other identifiers
interventional
30
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 depression
Started Feb 2009
Typical duration for phase_2 depression
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 3, 2009
CompletedFirst Posted
Study publicly available on registry
February 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
May 28, 2015
CompletedMay 28, 2015
May 1, 2015
1.8 years
February 3, 2009
March 13, 2015
May 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Depression Change
Baseline to 16 weeks
Quality of Life Change
Baseline to 16 weeks
Other Outcomes (2)
Long-term Open-label Responders
at the 24-month visit
Therapy-related Adverse Events
from enrollment to study closure (average follow-up of 36 months)
Study Arms (2)
Active Group - Active Stimulation
ACTIVE COMPARATORReceive active stimulation with Reclaim™ DBS System
Control Group - Sham Stimulation
SHAM COMPARATORReceive sham stimulation with Reclaim™ DBS System
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedtronicNeurolead
Study Sites (5)
Massachusetts General Hospital
Charlestown, Massachusetts, 02129, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Butler Hospital
Providence, Rhode Island, 02906, United States
Related Publications (5)
Dougherty DD, Rezai AR, Carpenter LL, Howland RH, Bhati MT, O'Reardon JP, Eskandar EN, Baltuch GH, Machado AD, Kondziolka D, Cusin C, Evans KC, Price LH, Jacobs K, Pandya M, Denko T, Tyrka AR, Brelje T, Deckersbach T, Kubu C, Malone DA Jr. A Randomized Sham-Controlled Trial of Deep Brain Stimulation of the Ventral Capsule/Ventral Striatum for Chronic Treatment-Resistant Depression. Biol Psychiatry. 2015 Aug 15;78(4):240-8. doi: 10.1016/j.biopsych.2014.11.023. Epub 2014 Dec 13.
PMID: 25726497RESULTGiacomo ED, Placenti V, Colmegna F, Clerici M. Obsessive-Compulsive Disorder in Pregnancy and Postpartum: The Possible Etiologic Role and Implications of Obsessive-Compulsive Personality Disorder. J Clin Psychiatry. 2021 Oct 19;82(6):21lr14069. doi: 10.4088/JCP.21lr14069. No abstract available.
PMID: 34670028DERIVEDFairbrother N, Collardeau F. High Prevalence of Perinatal-Occurring Obsessive-Compulsive Disorder: Reply to Di Giacomo et al. J Clin Psychiatry. 2021 Oct 19;82(6):21lr14069a. doi: 10.4088/JCP.21lr14069a. No abstract available.
PMID: 34670027DERIVEDHitti FL, Cristancho MA, Yang AI, O'Reardon JP, Bhati MT, Baltuch GH. Deep Brain Stimulation of the Ventral Capsule/Ventral Striatum for Treatment-Resistant Depression: A Decade of Clinical Follow-Up. J Clin Psychiatry. 2021 Oct 19;82(6):21m13973. doi: 10.4088/JCP.21m13973.
PMID: 34670026DERIVEDKubu CS, Brelje T, Butters MA, Deckersbach T, Malloy P, Moberg P, Troster AI, Williamson E, Baltuch GH, Bhati MT, Carpenter LL, Dougherty DD, Howland RH, Rezai AR, Malone DA Jr. Cognitive outcome after ventral capsule/ventral striatum stimulation for treatment-resistant major depression. J Neurol Neurosurg Psychiatry. 2017 Mar;88(3):262-265. doi: 10.1136/jnnp-2016-313803. Epub 2016 Sep 22.
PMID: 27659923DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
With this 30-subject cohort, and only 29 subjects completing the blinded-treatment phase per protocol, the comparisons of response rates and improvements were not adequately powered.
Results Point of Contact
- Title
- Eric Williamson, Clinical Evidence Specialist
- Organization
- Medtronic Neuromodulation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2009
First Posted
February 5, 2009
Study Start
February 1, 2009
Primary Completion
December 1, 2010
Study Completion
April 1, 2013
Last Updated
May 28, 2015
Results First Posted
May 28, 2015
Record last verified: 2015-05