This study is a multicenter, randomized, double-blind, placebo-controlled trial aimed at exploring the effectiveness and safety of rTMS intervention with DMPFC targets guided by pBFS in patients with treatment-resistant depression.
Repetitive transcranial magnetic stimulation (rTMS) is an established therapy for treatment-resistant depression. The dorsomedial prefrontal cortex (DMPFC), which serves as a connection intermediary of the aberrant functional network in cognitive control and rumination in depression, is highly correlated with disease manifestations and post-treatment improvements through several studies involving neuroimaging and brain injury. Research has shown that the response of DMPFC to rTMS is more subject to improving the dimensions of anxiety and insomnia in depression. Therefore, exploring the novel target DMPFC is also beneficial for distinguishing disease dimensions in the future, thereby enabling personalized treatment and improving clinical treatment efficacy. After being informed about the study and potential risks. All patients giving written informed consent will undergo a screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized double-blind in a 1:1 ratio to the active rTMS group, or sham-control group. Then all participants will undergo a 21-day rTMS modulation and a 3-week, 9-week, and 6-month post-treatment follow-up visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
270
Participants will receive 3 sessions per day of 1800 pulses per session, lasting for 21 days. Individualized targets will be generated using the pBFS method.
The parameters in the sham arms are the same as the active stimulation groups. Stimulation was delivered by the same device as the active group fitted with a sham coil.
Hebei Mental Health Center
Hebei, Baoding, China
RECRUITINGWest China Hospital, Sichuan University
Chengdu, China
NOT_YET_RECRUITINGInner Mongolia Mental Health Center
Hohhot, China
RECRUITINGChange in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to Immediate Post-treatment
The Montgomery-Asberg Depression Rating Scale (MADRS) is a validated instrument stratifying the severity of depressive episodes in adults. The MADRS has an overall score ranging from 0 (no depression) to 60 (worst depression).
Time frame: Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to Immediate Post-treatment
Remission and response rates were estimated using Montgomery-Asberg Depression Rating Scale(MADRS)
The response is defined as a symptom improvement of ≥50% and remission is defined as a score ≤10 on MADRS
Time frame: Baseline, Day 21 (Immediate Post-treatment)
Remission and response rates were estimated using Hamilton Depression Rating Scale (HAMD-17)
The Hamilton Depression Rating Scale (HAMD) is the most widely used clinician-administered depression assessment scale. The HAMD-17 version consists of 17 items，and has an overall score ranging from 0 (no depression) to 52 (worst depression). Higher scores represent higher depression severity. The response is defined as a symptom improvement of ≥50% and remission is defined as a score ≤7 on HAMD-17
Time frame: Baseline, Day 21 (Immediate Post-treatment)
Changes in the MADRS from baseline to each visit
The MADRS has an overall score ranging from 0 (no depression) to 60 (worst depression). Higher scores represent higher depression severity.
Time frame: Baseline, Day 21 (Immediate Post-treatment), 3-week Post-treatment, 9-week, and 6-month Post-treatment
Changes in the HAMD-17 from baseline to each visit
The Hamilton Depression Rating Scale (HAMD) is the most widely used clinician-administered depression assessment scale. The HAMD-17 version consists of 17 items，and has an overall score ranging from 0 (no depression) to 52 (worst depression). Higher scores represent higher depression severity.
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Shandong Daizhuang Hospital
Jining, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Xinxiang Medical University
Xinxiang, China
RECRUITINGTime frame: Baseline, Day 21 (Immediate Post-treatment), 3-week Post-treatment, 9-week Post-treatment
cognitive change in Digit Symbol Substitution Test (DSST)
Cognitive scores are measured using Chinese brief cognitive test (C-BCT), the DSST equires a subject to match symbols to numbers according to a key located on the top of the page
Time frame: Baseline, Day 21 (Immediate Post-treatment)
cognitive change in continuous performance test (CPT)
CPT from the C-BCT measures a person's sustained and selective attention
Time frame: Baseline, Day 21 (Immediate Post-treatment)
cognitive change in Trail-Making Test (TMT)
The TMT test from the C-BCT can provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning
Time frame: Baseline, Day 21 (Immediate Post-treatment)
cognitive change in Digit Span Test (DST)
DST from the C-BCT is a measure of verbal short term and working memory that can be used in two formats, Forward Digit Span and Reverse Digit Span
Time frame: Baseline, Day 21 (Immediate Post-treatment)