rTMS Intervention for DMPFC Treatment of Treatment-Resistant Depression Under the Guidance of Personalized Brain Functional Area Dissection (pBFS) Technology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 270
- 试验地点
- 5
- 主要终点
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to Immediate Post-treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Patients who meet the diagnostic criteria for depression in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and are not accompanied by psychiatric symptoms, with single or repeated episodes;
- •(2) The Hamilton Depression Scale (HAMD) score for 17 items before randomization was ≥ 20 points, and the Montgomery Asberg Depression Rating Scale (MADRS) score was ≥ 20 points;
- •(3) Individuals aged ≥ 18 and ≤ 65 years old, regardless of gender;
- •(4) Currently, at least one antidepressant has been used for 6 weeks and the dosage used cannot be lower than the prescribed range of drug use;
- •(5) The Maudsley Staging Method (MSM) assesses patients as having at least moderate refractory levels (MSM score ≥ 7);
- •(6) Before randomization, the current antidepressant treatment regimen should be stable for at least 4 weeks, and the dosage used should not be lower than the prescribed range of drug use;
- •(7) Having received education for 5 years or more;
- •(8) Understand the experiment and sign an informed consent form.
排除标准
- •(1) Meets the DSM-5 diagnostic criteria for other mental disorders, including schizophrenia spectrum disorders, bipolar and related disorders, neurodevelopmental disorders, neurocognitive disorders, or depression caused by substances and/or drugs, or depression caused by other medical issues;
- •(2) Individuals with pacemakers, cochlear implants, or other metal foreign objects, as well as any electronic devices implanted in the body, contraindications for magnetic resonance imaging scans such as claustrophobia, and contraindications for rTMS treatment;
- •(3) Concomitant history of epilepsy (with at least 2 non induced seizures with an interval of more than 24 hours, diagnosed with epilepsy syndrome, or having seizures within the past 12 months);
- •(4) Individuals who have received modified electroconvulsive mECT, rTMS, or light therapy within 3 months;
- •(5) Concomitant organic brain diseases (such as ischemic stroke, cerebral hemorrhage, brain tumors, etc.) and a history of severe brain injury;
- •(6) Complicated with serious heart, liver, kidney diseases, diabetes and other serious physical diseases;
- •(7) Women of childbearing age who are currently pregnant, breastfeeding, or planning or may become pregnant during the trial period;
- •(8) Have a history of drug and alcohol abuse within the past year;
- •(9) First degree relatives suffer from bipolar disorder;
- •(10) There is a significant risk of suicide (the 10th item of the MADRS scale is ≥ 5 points);
- •(11) Difficulty in verbal communication to the point of being unable to communicate normally, understand or follow instructions, and unable to cooperate with treatment and evaluation;
- •(12) Currently participating in clinical trials of other drugs or physical therapies (such as deep brain stimulation (DBS), electroconvulsive therapy (ECT), rTMS);
- •(13) The researchers believe it is not suitable to participate.
结局指标
主要结局
Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to Immediate Post-treatment
时间窗: Change 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).
次要结局
- cognitive change in continuous performance test (CPT)(Baseline, Day 21 (Immediate Post-treatment))
- cognitive change in Trail-Making Test (TMT)(Baseline, Day 21 (Immediate Post-treatment))
- Remission and response rates were estimated using Montgomery-Asberg Depression Rating Scale(MADRS)(Baseline, Day 21 (Immediate Post-treatment))
- Changes in the MADRS from baseline to each visit(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(Baseline, Day 21 (Immediate Post-treatment), 3-week Post-treatment, 9-week Post-treatment)
- cognitive change in Digit Symbol Substitution Test (DSST)(Baseline, Day 21 (Immediate Post-treatment))
- Remission and response rates were estimated using Hamilton Depression Rating Scale (HAMD-17)(Baseline, Day 21 (Immediate Post-treatment))
- cognitive change in Digit Span Test (DST)(Baseline, Day 21 (Immediate Post-treatment))