Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528938
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-14
Brief Title:
Comparing the Efficacy of Accelerated vs Standard fMRI-guided iTBS in Treating Adolescents Depression
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Pilot Trial Comparing the Feasibility and Efficacy of Accelerated vs Standard fMRI-guided iTBS in Treatment-Resistant Depression in Adolescents
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Repetitive transcranial magnetic stimulation rTMS is a Health Canada approved treatment for major depression Theta burst stimulation TBS a type of rTMS is a very promising new treatment for major depression in adults and adolescents However very few studies have assessed the efficacy of accelerated three times a day TBS in comparison with standard once a day TBS in adolescents The study aims to explore further evidence in hopes to conduct a large-scale randomized multisite placebo-controlled clinical trial evaluating the effects of a functional magnetic resonance imaging fMRI-guided accelerated rTMS protocol vs standard oncedaily rTMS for treatment-resistant depression in adolescents
Detailed Description:
Recently the efficacy of repetitive Transcranial Magnetic Stimulation rTMS has significantly improved for Treatment-Resistant Depression TRD in adults and promising evidence suggesting safety and efficacy of rTMS in adolescents These youth studies currently use outdated stimulation protocols with most of them using treatments on a oncedaily schedule Given the prevalence morbidity and mortality associated with depression in adolescents and considering that over 40 of adolescents do not respond to medications a randomized controlled trial RCT to establish the safety and efficacy of new rTMS protocols for difficult-to-treat depression in adolescents is desperately needed
This open-label randomized controlled trial will compare accelerated intermittent theta burst stimulation iTBS and standard once a day iTBS in adolescents with major depressive disorder MDD For this pilot trial 10 adolescents 5 females 5 males with treatment-resistant depression will be recruited Each participant will undergo a 30-40-minute magnetic resonance imaging MRI scan after which they will receive iTBS applied to the left dorsolateral prefrontal cortex DLPFC once a day for 6 weeks standard treatment or for an accelerated duration of 3 times a day for 2 weeks Symptoms will be assessed through clinical assessments as well as self-report questionnaires Prior to treatment start each participant will complete the clinical assessments as well as the self-report questionnaires for a baseline measurement The self-report measures will be completed every 5th treatment total of 7 times including baseline The clinical assessments will be completed after the 15th and 30th treatment as well as 2-4- and 12-weeks post treatment course total of 6 times including baseline The main outcome of this trial is a clinical response rate which will be defined as a 50 reduction in depressive symptoms based off of the Childrens Depression Rating Scale Revised for depression CDRS-R The secondary outcome of this trial is suicidal ideation which will be measured by the Beck Scale for Suicidal Ideation BSS as well as several other outcomes such as anxiety sleep quality physical activity and stress The ultimate goal of this study is to provide initial evidence for conducting a large-scale randomized multisite placebo-controlled clinical trial evaluating the effects of an fMRI-guided accelerated rTMS protocol vs standard oncedaily rTMS for treatment-resistant depression in adolescents
This open-label randomized controlled trial will compare accelerated intermittent theta burst stimulation iTBS and standard once a day iTBS in adolescents with major depressive disorder MDD For this pilot trial 10 adolescents 5 females 5 males with treatment-resistant depression will be recruited Each participant will undergo a 30-40-minute magnetic resonance imaging MRI scan after which they will receive iTBS applied to the left dorsolateral prefrontal cortex DLPFC once a day for 6 weeks standard treatment or for an accelerated duration of 3 times a day for 2 weeks Symptoms will be assessed through clinical assessments as well as self-report questionnaires Prior to treatment start each participant will complete the clinical assessments as well as the self-report questionnaires for a baseline measurement The self-report measures will be completed every 5th treatment total of 7 times including baseline The clinical assessments will be completed after the 15th and 30th treatment as well as 2-4- and 12-weeks post treatment course total of 6 times including baseline The main outcome of this trial is a clinical response rate which will be defined as a 50 reduction in depressive symptoms based off of the Childrens Depression Rating Scale Revised for depression CDRS-R The secondary outcome of this trial is suicidal ideation which will be measured by the Beck Scale for Suicidal Ideation BSS as well as several other outcomes such as anxiety sleep quality physical activity and stress The ultimate goal of this study is to provide initial evidence for conducting a large-scale randomized multisite placebo-controlled clinical trial evaluating the effects of an fMRI-guided accelerated rTMS protocol vs standard oncedaily rTMS for treatment-resistant depression in adolescents
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None