Research on the Efficacy and Brain Network Mechanism of Personalized Targeting Intermittent Theta Burst Stimulation (iTBS) Based on Functional Magnetic Resonance Imaging for the Treatment of Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Change in the 17-Item Hamilton Rating Scale for Depression (HAMD-17) Score from Baseline to 4 weeks post treatment
研究概览
简要总结
The study will compare the efficacy of intermittent Theta Burst Stimulation (iTBS) with DLPFC-pgACC personalized target for major depressive disorder (MDD) and explore possible brain network mechanisms. The stimulated targets will be located by magnetic resonance imaging (MRI) based on functional MRI based on functional connectivity respectively. This study aims to identify that functional connectivity targeted iTBS protocols on DLPFC-pgACC personalized target have a better antidepressant efficacy compared the sham group and certify that pgACC is an effective potential effector target.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 60 years old
- •Meet the criteria of the Diagnostic and Statistical Manual of Mental Disorder- V of MDD, single or recurrent
- •Meet the threshold on the total HAMD17 score of >17 at both screening and baseline visits
- •Able to provide informed consent
排除标准
- •any other current or past psychiatric axis-I or axis-II disorders
- •severe physical illnesses
- •psychotic symptoms, alcohol or drug abuse
- •A history of neurological disorders including seizure, cerebral trauma
- •MRI evidence of structural brain abnormalities
- •Contraindications to MRI and rTMS
- •Acute suicide
- •Female that is pregnant or breastfeeding
研究组 & 干预措施
functional MRI-guided iTBS(sham group)
The stimulating site of the left DLPFC is targeted based on functional MRI, where the most negative functional connectivity with the left pgACC. The MNI coordinate is (-10, 42, 6).
干预措施: sham iTBS combined with antidepressants (Combination Product)
functional MRI-guided iTBS (pgACC-DLPFC)
The stimulating site of the left DLPFC is targeted based on functional MRI, where the most negative functional connectivity with the left pgACC. The MNI coordinate is (-10, 42, 6).
干预措施: iTBS combined with antidepressants (Combination Product)
结局指标
主要结局
Change in the 17-Item Hamilton Rating Scale for Depression (HAMD-17) Score from Baseline to 4 weeks post treatment
时间窗: baseline and 4-week post treatment
The HAMD-17 total score comprises a sum of the 17 individual item scores. Each item is rated on a 3 points scale from 0 to 2. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression.
次要结局
- Therapeutic response rate and remission rate(immediately post-treatment)
- Change in the Beck Scale for Suicidal Ideation-Chinese Version (BSI-CV) Score(baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment)
- Change From Baseline Functional Connectivity to Immediately Post-treatment(baseline、immediately post treatment and 4-week post-treatment)
- Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score(baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment)
- Change in the Hamilton Anxiety Scale (HAMA) Score(baseline, immediately post-treatment and 2-week, 4-week and 8-week post-treatment)