Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518642
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Transcranial Direct Current Stimulation tDCS in Young Individuals With Major Depressive Disorder a Literature Review and Feasibility Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Transcranial Direct Current Stimulation tDCS in Young Individuals With Major Depressive Disorder a Literature Review and Feasibility Study
Status:
COMPLETED
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:
Objectives 1 To assess the therapeutic effects of tDCS on improving depressive symptoms in young individuals with Major Depressive Disorder MDD relative to sham stimulation and 2 to evaluate the tolerability and feasibility of tDCS in young individuals with Major Depressive Disorder to explore the feasibility for a scale-up study
Hypothesis 1 we hypothesize the tDCS stimulation of the dorsolateral prefrontal cortex dLPFC will reduce symptoms of depression more than sham stimulation demonstrated by significant difference in change of Hamilton Depression Rating Scale HDRS and 2 tDCS active stimulation of the dLPFC will be tolerable and feasible among patients with MDD as demonstrated by minimal adverse effects measured in the Adverse Events Questionnaire adherence with reasons of drop out their motivation and enjoyment to participate in the study
Hypothesis 1 we hypothesize the tDCS stimulation of the dorsolateral prefrontal cortex dLPFC will reduce symptoms of depression more than sham stimulation demonstrated by significant difference in change of Hamilton Depression Rating Scale HDRS and 2 tDCS active stimulation of the dLPFC will be tolerable and feasible among patients with MDD as demonstrated by minimal adverse effects measured in the Adverse Events Questionnaire adherence with reasons of drop out their motivation and enjoyment to participate in the study
Detailed Description:
The incidence of probable depression during the fifth peak of COVID-19 was 246 within the HK population with the youths having experienced a disproportionately higher rate A recent epidemiology survey conducted in HK revealed the 12-month prevalence of suicidal ideation among young individuals above secondary school age to be an alarming 84 While guidelines and RCTs support the use of medication and psychotherapy as a standalone or combination treatments for major depressive disorder MDD in youths a large proportion do not respond to either medication or psychotherapy There is therefore an unmet need for new effective treatment options for depression that can be tolerated by young individuals Transcranial direct current simulation tDCS has its acute-effect is physiological change that reduces the threshold of membrane polarisation and increased the synaptic excitability A handful of studies suggested that anodal stimulation of the dorsal lateral prefrontal cortex DLPFC is effective in reducing depressive symptoms in adults however whether similar effects applies to youth remains unknown tDCS is portable relatively inexpensive and easy to use proving to be very safe and tolerable for young individuals with minimal and temporary side effects
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