Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372834
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-04-15
Brief Title:
Adjuvant Accelerated piTBS for Reducing Suicidal Ideation in TRD Patients
Sponsor:
Tri-Service General Hospital
Organization:
Tri-Service General Hospital
Study Overview
Official Title:
Efficacy of Adjuvant Accelerated Prolonged Intermittent Theta Burst Stimulation for Reducing Suicidal Ideation in Therapy-resistant Depressed Patients A Randomized Sham-controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-06
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:
In this double-blind randomized sham-controlled trial the investigators aimed to examine the effect of accelerated piTBS on suicide risk in a group of treatment-resistant patients with MDD ie TRD using an extensive suicide assessment scale the primary outcome The investigators hypothesized that this intensified treatment protocol would be safe in TRD patients with suicide ideations and would result in significant decreases in suicide risk in the active treatment condition as compared to the sham condition
Detailed Description:
Less than half of patients with major depressive disorder MDD remit after first-line therapy ie pharmacotherapy andor psychotherapy A progressively smaller proportion of patients remit with each subsequent medication trial and a remission rate of only 10-15 after a fourth antidepressant trial Patients with MDD are considered to have a treatment-resistant depression TRD whey they do not achieve response to first-line antidepressants Repetitive Transcranial Magnetic Stimulation rTMS applied over the DLPFC for modulating brain activity and network connectivity has well-documented positive effects on major depressive disorder MDD especially TRD rTMS research in treating MDD has shown a dose-response relationship and more recently studies have shown a trend towards administering more stimuli over a shorter period of time and at higher frequencies leading to accelerated protocols An optimized rTMS parameter called intermittent theta burst stimulation iTBS is a novel protocol that consists of intermittently delivering bursts of 3 TMS pulses at high frequency 50 Hz every 200 ms for 2 s 5Hz every 10 s total 600 pulses allowing for greater long-lasting effects on cortical excitability and a more important number of rTMS pulses to be delivered in a shorter duration than standardized high frequency HF rTMS protocols iTBS induces a long-term potentiation LTP-like effect by increasing the postsynaptic concentration of calcium ions and has been applied to treat MDD iTBS has been proved to be safe and well tolerated and to have antidepressant properties Prolonged iTBS piTBS total 1800 pulses has been recently applied to treat MDD with favorable antidepressant properties An accelerated protocol of piTBS has been recently approved to treat medication-refractory MDD by FDA
MDD is associated with a 23 fold increase in prevalence of suicidal ideation as compared to the general population The lifetime rate of death due to suicide among MDD patients is 15-20 Research indicates that 30 of TRD patients will attempt suicide during their lifetime which is a two-to-four times greater proportion than MDD patients who respond to treatment Research indicates that rTMS improves several preconditions for suicide including mood memory attention executive functioning rTMS is thought to have molecular effects similar to those seen with electroconvulsive therapy ECT which is effective in treating suicidal patients such as increased BDNF increased monoamine turnover and normalization of the hypothalamic-pituitary-adrenal axis Some research indicates that rTMS may reduce suicidal ideations of patients with MDD However powered sham-controlled rTMS clinical trials focusing on the efficacy to improve suicide risks are limited
The study aims to investigate the efficacy of accelerated piTBS over the left DLPFC as an add-on therapy to improve suicide ideations in TRD patients Moreover it provides data on other secondary outcomes and neurophysiological data for this intervention condition
MDD is associated with a 23 fold increase in prevalence of suicidal ideation as compared to the general population The lifetime rate of death due to suicide among MDD patients is 15-20 Research indicates that 30 of TRD patients will attempt suicide during their lifetime which is a two-to-four times greater proportion than MDD patients who respond to treatment Research indicates that rTMS improves several preconditions for suicide including mood memory attention executive functioning rTMS is thought to have molecular effects similar to those seen with electroconvulsive therapy ECT which is effective in treating suicidal patients such as increased BDNF increased monoamine turnover and normalization of the hypothalamic-pituitary-adrenal axis Some research indicates that rTMS may reduce suicidal ideations of patients with MDD However powered sham-controlled rTMS clinical trials focusing on the efficacy to improve suicide risks are limited
The study aims to investigate the efficacy of accelerated piTBS over the left DLPFC as an add-on therapy to improve suicide ideations in TRD patients Moreover it provides data on other secondary outcomes and neurophysiological data for this intervention condition
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?:
False
Is an FDA AA801 Violation?:
None