Ignite Creation Date:
2024-05-06 @ 10:50 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03360942
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-02-23
First Post:
2017-08-17
Brief Title:
Long Term Follow-up of Deep Brain Stimulation for Treatment-Resistant Depression
Sponsor:
Paul Holtzheimer
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
Long Term Follow-up of Deep Brain Stimulation for Treatment-Resistant Depression
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The long term follow up of a pilot study in which the invesitagors proposed to test whether high frequency stimulation of the subcallosal cingulate SCC is a safe and efficacious antidepressant treatment in five TRD patients to compare the effects of left-sided vs right-sided stimulation and to investigate potential mechanisms of action of this intervention Importantly this study will be used to assess the need for and assist in planning a larger more definitive trial of SCC DBS for TRD
Detailed Description:
The US 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 US 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 therapyECT 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
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 therapyECT 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 23442 | OTHER | Dartmouth Committee for the Protection of Human Subjects | None |