Personalized Functional-Connectivity-Targeted Accelerated Intermittent Theta-Burst Stimulation Versus Sham for Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From pre-treatment baseline (Day -1) to 4 weeks post-treatment (Week 4; Day 34, corresponding to 28 days after the first post-treatment assessment visit)
研究概览
简要总结
This randomized, double-blind, sham-controlled, parallel-group clinical trial will evaluate the efficacy and safety of individualized functional connectivity-guided accelerated intermittent theta-burst stimulation (iTBS) in adults with major depressive disorder (MDD). A total of 90 participants will be randomly assigned in a 1:1 ratio to receive either active iTBS or matched sham stimulation. Treatment will be administered over 5 consecutive days, with 10 stimulation sessions per day.
For each participant, an individualized stimulation target within the left dorsolateral prefrontal cortex will be identified using resting-state functional magnetic resonance imaging (MRI). The primary objective is to compare the change in depressive symptoms, measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), from pre-treatment baseline (Day -1) to 4 weeks post-treatment (Week 4; Day 34) between the active and sham groups. Changes in other clinical symptoms, treatment response, remission, and safety will also be assessed during follow-up through 8 weeks after treatment.
Multimodal MRI, resting-state electroencephalography (EEG), and transcranial magnetic stimulation combined with EEG (TMS-EEG) will be collected at prespecified time points. These measures will be used to explore treatment-related changes in brain function and connectivity and to identify potential neuroimaging and neurophysiological biomarkers associated with clinical improvement and the maintenance of treatment effects.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 四盲 (受试者、医护人员、研究者、结局评估者)
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Aged 22 to 65 years, regardless of sex. Right-handed.
- Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for major depressive disorder, confirmed using the Mini International Neuropsychiatric Interview (MINI), version 7.0.The current major depressive episode has lasted for at least 4 weeks.
- Montgomery-Åsberg Depression Rating Scale (MADRS) total score of 20 or greater at both screening and baseline.
- Stable depressive symptoms, defined as a difference in MADRS total score between screening and baseline of no more than 20%.
- Currently medication-free or receiving a stable dose of psychiatric medication for at least 4 weeks before enrollment, with agreement to maintain the same medication regimen through the Week 4 follow-up.
- Able to provide a complete and verifiable history of previous antidepressant treatments.
- Eligible to undergo magnetic resonance imaging (MRI).
- Able to complete all protocol-specified resting-state electroencephalography (EEG) and transcranial magnetic stimulation-electroencephalography (TMS-EEG) assessments.
- Able to understand and comply with the study procedures and provide written informed consent.
排除标准
- Current or previous diagnosis of bipolar disorder, a psychotic disorder, primary obsessive-compulsive disorder, post-traumatic stress disorder, or another psychiatric disorder considered incompatible with study participation.
- A response of "yes" to Item 4 or Item 5 of the suicidal ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) during the current depressive episode; suicidal behavior within the 6 months before screening; or current high suicide risk as determined by the investigator.
- A change of more than 20% in MADRS total score between screening and baseline.
- A skull defect or fracture, treatment-resistant epilepsy, brain tumor, stroke, or another serious medical or neurological condition that may affect study participation or safety.
- A cardiac pacemaker, cochlear implant, MRI-incompatible metallic foreign body, implanted electronic device, claustrophobia, or another contraindication to MRI or transcranial magnetic stimulation.
- Pregnant or breastfeeding.
- Participation in another drug or medical-device clinical trial within 1 month before screening.
- Receipt of electroconvulsive therapy, repetitive transcranial magnetic stimulation, transcranial direct current stimulation, vagus nerve stimulation, deep brain stimulation, light therapy, or another systematic neuromodulation treatment within 1 month before screening.
- Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in the study.
研究组 & 干预措施
Active: Accelerated iTBS
Participants in this arm will receive personalized functional-connectivity-targeted accelerated intermittent theta-burst stimulation to the left dorsolateral prefrontal cortex. The treatment consists of 10 sessions per day for 5 consecutive days, with 1,800 pulses per session, 90,000 pulses total, 90% resting motor threshold with depth adjustment, and a 50-minute inter-session interval.
干预措施: Personalized Functional-Connectivity-Targeted Accelerated iTBS (Device)
Sham: Accelerated iTBS
Participants in this arm will receive sham accelerated intermittent theta-burst stimulation using the same imaging-based targeting workflow and the same 10 sessions per day for 5 consecutive days schedule. The sham system is designed to match coil positioning, sound, and scalp sensation, while delivering no effective cortical magnetic field.
干预措施: Sham Accelerated iTBS (Device)
结局指标
主要结局
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From pre-treatment baseline (Day -1) to 4 weeks post-treatment (Week 4; Day 34, corresponding to 28 days after the first post-treatment assessment visit)
时间窗: Pre-treatment baseline (Day -1) to 4 weeks post-treatment (Week 4; Day 34)
Change in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline (Day -1) to 4 weeks post-treatment (Week 4; Day 34, corresponding to 28 days after the first post-treatment assessment visit). The MADRS assesses the severity of depressive symptoms, with higher scores indicating greater severity. A greater reduction indicates greater improvement in depressive symptoms
次要结局
- Montgomery-Åsberg Depression Rating Scale (MADRS) Response Rate(Pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 4 weeks post-treatment (Week 4; Day 34), 6 weeks post-treatment (Week 6; Day 48), and 8 weeks post-treatment (Week 8; Day 62).)
- Montgomery-Åsberg Depression Rating Scale (MADRS) Remission Rate(1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 4 weeks post-treatment (Week 4; Day 34), 6 weeks post-treatment (Week 6; Day 48), and 8 weeks post-treatment (Week 8; Day 62).)
- Change From Pre-treatment baseline (Day -1) in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Follow-up Visits(Pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 6 weeks post-treatment (Week 6; Day 48), and 8 weeks post-treatment (Week 8; Day 62).)
- Change in the 30-Item Inventory of Depressive Symptomatology-Self-Report (IDS-SR30) Total Score(Screening (Day -8), pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 4 weeks post-treatment (Week 4; Day 34), 6 weeks post-treatment (Week 6; Day 48), and 8 weeks post-treatment (Week 8; Day 62).)
- Change in 17-item Hamilton Depression Rating Scale (HAM-D-17) Total Score(Screening (Day -8), pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 4 weeks post-treatment (Week 4; Day 34), 6 weeks post-treatment (Week 6; Day 48), and 8 weeks post-treatment (Week 8; Day 62).)
- Change in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score(Pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 4 weeks post-treatment (Week 4; Day 34), 6 weeks post-treatment (Week 6; Day 48), and 8 weeks post-treatment (Week 8; Day 62).)
- Change in Clinical Global Impression (CGI) Score(Pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 4 weeks post-treatment (Week 4; Day 34), 6 weeks post-treatment (Week 6; Day 48), and 8 weeks post-treatment (Week 8; Day 62).)
- Change in Pittsburgh Sleep Quality Index (PSQI) Total Score(Pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 4 weeks post-treatment (Week 4; Day 34), and 8 weeks post-treatment (Week 8; Day 62).)
- Change in MATRICS Consensus Cognitive Battery (MCCB) Scores(Pre-treatment baseline (Day -1), 1 day post-treatment (Day 6), 1 week post-treatment (Week 1; Day 13), 4 weeks post-treatment (Week 4; Day 34), and 8 weeks post-treatment (Week 8; Day 62).)
研究者
Gang Wang
Prof.
Capital Medical University
标识符
- NCT 编号
- NCT07843875
- 其他研究编号
- 2026(43), YG202603, 3-1-99-2026-pt22
日期
- 首次提交
- (2个月前)
- 首次发布
- (前天)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 否