Long Term Follow-up of Deep Brain Stimulation for Treatment-Resistant Depression
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03360942|
Recruitment Status : Active, not recruiting
First Posted : December 4, 2017
Last Update Posted : August 15, 2018
|Condition or disease||Intervention/treatment|
|Treatment Resistant Depression Depressive Disorder, Treatment-Resistant Depression, Bipolar||Device: SCC DBS|
The U.S. lifetime prevalence of major depressive disorder (MDD) is 17%. A number of treatments are available for depression including medications, psychotherapy and various somatic treatments. Unfortunately, up to two-thirds of patients remain symptomatic following first-line treatment and a third fail to achieve remission (defined as full resolution of depressive symptoms) after four established treatments; approximately 10%-20% of depressed patients may show virtually no improvement despite multiple, often aggressive treatments. Thus, a conservative estimate places the U.S. prevalence of treatment-resistant depression (TRD) at 1%-3%. TRD has a high risk of suicide, is a major cause of disability and is responsible for doubling of overall health care costs.
For patients with TRD there are limited evidence-based treatment options. Transcranial magnetic stimulation (TMS) may have efficacy for patients that have failed no more than one antidepressant medication 10-12, but response and remission rates are relatively low (under 30% and 20% respectively). Vagus nerve stimulation (VNS) may have efficacy in patients that have failed 4-6 antidepressant treatments but long-term response and remission rates are again low (about 20% and 10% respectively). Electroconvulsive therapy(ECT) can be effective in TRD patients with remission rates of 50%-60%. However, more than 70% of TRD patients will relapse within 6 months following a successful acute treatment course. For patients that have failed ECT, there are no evidence-based treatment options. Therefore, there is great need for novel treatment approaches for TRD.
Prior clinical trials have shown that SCC DBS has the potential to be a valuable treatment option for patients with TRD. Further developing this treatment will involve confirming its effectiveness and identifying ways to optimize its use. In this study the investigators intend to test the safety and efficacy of chronic SCC DBS as a treatment for TRD and compare the safety and efficacy of left-sided versus right-sided stimulation using a double-blind, randomized, cross-over design.
|Study Type :||Observational|
|Actual Enrollment :||5 participants|
|Official Title:||Long Term Follow-up of Deep Brain Stimulation for Treatment-Resistant Depression|
|Actual Study Start Date :||April 18, 2016|
|Estimated Primary Completion Date :||November 22, 2026|
|Estimated Study Completion Date :||November 22, 2028|
DBS Long Term Follow Up
5 participants who were in a prior study to receive DBS are enrolled to have their progress and DBS devices monitored for a period of 12 years.
Device: SCC DBS
Deep Brain Stimulator
Other Name: Libra(TM) Implantable Deep Brain Stimulation (DBS) System
- Depressive symptoms measured by the 17-item Hamilton Depression Rating [ Time Frame: Change from baseline Hamilton-17 score to follow-up visits at 1, 3, 6, 9, 12, 18, and 24 months after initial DBS treatment ]Depressive symptoms will be measured by the 17-item Hamilton Depression Rating Scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360942
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03766|