Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06172413
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-31
First Post:
2023-12-07
Brief Title:
Transcranial Alternating Current Stimulation for Treatment-Resistant Depression
Sponsor:
Xuanwu Hospital Beijing
Organization:
Xuanwu Hospital Beijing
Study Overview
Official Title:
Twice-daily 15 mA Transcranial Alternating Current Stimulation for Treatment-Resistant Depression
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
This trial aims to investigate the effect of twice-daily 15 mA transcranial alternating current stimulation tACS through three conductive electrodes attached to the scalp in subjects with treatment-resistant depression TRD Two hundred adult subjects with TRD will be included in this randomized double-blind parallelized multi-centre study The primary outcome is the change of the Montgomery-Asberg Depression Rating Scale MADRS after four weeks of tACS
Detailed Description:
This is an 8-week multicenter double-blind sham-controlled randomized parallel-group trial
TRD is defined as failure of response to at least two antidepressant medication trials based on the Massachusetts General Hospital antidepressant treatment response questionnaire MGH-ATRQ Patients will be randomized if they remain moderately ill assessed by Hamilton Depression Scale-item 17 HAMD-17 score 20 The primary outcome is a change in the MADRS total score after four weeks of tACS
Remission is defined as MADRS total score 10 at Week 4 and Week 8 Response is a 50 reduction in MADRS total score from baseline to Week 4 and Week 8
All participants will receive 40 sessions with stimulation at 775 Hz and 15 mA Active group or sham stimulation Sham group
Each session will last 40 minutes from Monday to Friday at a fixed daytime interval for four continuous weeks
TRD is defined as failure of response to at least two antidepressant medication trials based on the Massachusetts General Hospital antidepressant treatment response questionnaire MGH-ATRQ Patients will be randomized if they remain moderately ill assessed by Hamilton Depression Scale-item 17 HAMD-17 score 20 The primary outcome is a change in the MADRS total score after four weeks of tACS
Remission is defined as MADRS total score 10 at Week 4 and Week 8 Response is a 50 reduction in MADRS total score from baseline to Week 4 and Week 8
All participants will receive 40 sessions with stimulation at 775 Hz and 15 mA Active group or sham stimulation Sham group
Each session will last 40 minutes from Monday to Friday at a fixed daytime interval for four continuous weeks
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