Clinical trial NCT00837486: Reclaim Deep Brain Stimulation Clinical Study for Treatment-Resistant Depression
Official title: Reclaim Deep Brain Stimulation Clinical Study for Treatment-Resistant Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Keywords: Treatment Resistant Depression
Treatment Refractory Depression
Deep Brain Stimulation
Depression
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2009-02-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Responders
timeFrame: Baseline to 16 weeks
Secondary outcomes:
measure: Depression Change
timeFrame: Baseline to 16 weeks
measure: Quality of Life Change
timeFrame: Baseline to 16 weeks
Other outcomes:
measure: Long-term Open-label Responders
timeFrame: at the 24-month visit
measure: Therapy-related Adverse Events
timeFrame: from enrollment to study closure (average follow-up of 36 months)
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
References:
citation: 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.
citation: Giacomo 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.
citation: Fairbrother 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.
citation: Hitti 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.
citation: Kubu 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.