Ignite Creation Date:
2024-05-06 @ 3:09 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04530942
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-25
First Post:
2020-08-25
Brief Title:
The Efficacy and Prediction of Deep Brain Stimulation for Treatment-resistant Depression
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
The Efficacy and Prediction of Deep Brain Stimulation for Treatment-resistant Depression
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
Several open-label trials have shown the therapeutic promise of deep brain stimulation DBS targeted to striatal and surrounding capsular areas in treatment-resistant depression TRD However the results of placebo-controlled trials have been mixed with one showing a large difference between active and sham DBS and another finding no difference
Main aim of this study is establishing whether active DBS results in more treatment responders than sham DBS Secondary aims are establishing an adverse events profile establishing effects on quality of lifeneuropsychological and neuroimaging measures and finding predictors of response
Main aim of this study is establishing whether active DBS results in more treatment responders than sham DBS Secondary aims are establishing an adverse events profile establishing effects on quality of lifeneuropsychological and neuroimaging measures and finding predictors of response
Detailed Description:
Major Depressive Disorder MDD is a highly prevalent psychiatric disorder with an estimated lifetime prevalence of 146 across high-income countriesEffective therapeutic options for MDD include psychotherapy different classes of antidepressants and electroconvulsive therapy ECT Nevertheless up to 30 of patients do not respond to four consecutive antidepressant strategies and 52 of pharmacotherapy resistant patients do not respond to ECTSuch patients are designated an advanced stage of Treatment Resistant Depression TRD which is associated with more hospitalizations more suicide attempts and higher costs than non-TRD patients
Deep Brain Stimulation DBS is a promising therapeutic option for TRD patients DBS consists of implanting electrodes in specific brain areas and then optimizing stimulation parameters eg voltage frequency pulse width to modulate brain activity of the targeted area Since 2005 several open label trials have reported promising effects of DBS in TRD targeting different brain structures involved in the neurobiology of MDD the Subcallosal Cingulate Gyrus SCGMedial Forebrain Bundle MFBVentral CapsuleVentral Striatum VCVS and Nucleus Accumbens NAc Response rates defined as a symptom decrease of at least 50 range from 30 to 90 with most studies finding a response rate around 50
However results of the first two randomized trials are mixed The first randomized controlled trial RCT of VCVS DBS in TRD did not find differences in response rates following active 3 of 14 patients or sham stimulation 2 of 15 patients after four months of stimulation In contrast another group found a strong antidepressant effect in 16 patients with TRD following active ventral Anterior Limb of the Internal Capsule vALIC DBS compared to sham stimulation in a randomized crossover phase
Therefore this trial aims to establishing whether active DBS results in more treatment responders than sham DBS Secondary aims are establishing an adverse events profile establishing effects on quality of lifeneuropsychological and neuroimaging measures and finding predictors of response
Deep Brain Stimulation DBS is a promising therapeutic option for TRD patients DBS consists of implanting electrodes in specific brain areas and then optimizing stimulation parameters eg voltage frequency pulse width to modulate brain activity of the targeted area Since 2005 several open label trials have reported promising effects of DBS in TRD targeting different brain structures involved in the neurobiology of MDD the Subcallosal Cingulate Gyrus SCGMedial Forebrain Bundle MFBVentral CapsuleVentral Striatum VCVS and Nucleus Accumbens NAc Response rates defined as a symptom decrease of at least 50 range from 30 to 90 with most studies finding a response rate around 50
However results of the first two randomized trials are mixed The first randomized controlled trial RCT of VCVS DBS in TRD did not find differences in response rates following active 3 of 14 patients or sham stimulation 2 of 15 patients after four months of stimulation In contrast another group found a strong antidepressant effect in 16 patients with TRD following active ventral Anterior Limb of the Internal Capsule vALIC DBS compared to sham stimulation in a randomized crossover phase
Therefore this trial aims to establishing whether active DBS results in more treatment responders than sham DBS Secondary aims are establishing an adverse events profile establishing effects on quality of lifeneuropsychological and neuroimaging measures and finding predictors of response
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None