Personalized Brain Functional Sectors (pBFS)-Guided DMPFC With High-dose rTMS for Treatment-resistant Depressive Disorder: a Randomized, Double-blind, Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- change in Montgomery-Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
The investigators aim to evaluate the safety and efficacy of pBFS-guided DMPFC target and high-dose rTMS therapy for the treatment of patients with treatment-resistant depression
详细描述
Repetitive transcranial magnetic stimulation (rTMS) is an established therapy for treatment-resistant depression. Currently, the FDA cleared the SAINT Neuromodulation System for the treatment of Treatment-Resistant Depression(TRD) over the left dorsolateral prefrontal cortex (DLPFC). This methodology has been effective in a short period of time for treatment-resistant depression. However, some patients may not be able to persist in completing the treatment because they cannot bear the pain during treatment. The dorsomedial prefrontal cortex (DMPFC) region is relatively posterior, and DMPFC as an intervention target has been proven to have antidepressant effects, and patients have better pain tolerance during treatment, which can be used as an alternative to DLPFC target, so it is urgent to explore the effectiveness and safety of high-dose iTBS targeting DMPFC in the treatment of depression.
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 in a blind manner in a 2:1 ratio to the active-rTMS group, and sham-rTMS group. Then all participants will undergo a 5-day rTMS modulation followed by two-week and four-week follow-up visits. Participants will keep a stable treatment regime during treatment and the four-week follow-up.
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
- •DSM-5 diagnosis of depressive disorder, recurrent episodes;
- •A total score of at least 20 on the HAMD-17 and Montgomery-Asberg Depression Rating Scale;
- •Aged 18-65 years, female or male;
- •Inadequate response to at least one antidepressant trial of adequate doses and duration;
- •The MSM (Maudsley Staging Method) score ≥ 7;
- •Stable antidepressant regimen for at least 4 weeks before treatment;
- •Understand the trial and sign the informed consent.
排除标准
- •Meet DSM-5 diagnostic criteria for other mental disorders (such as schizophrenia spectrum disorders, bipolar and related disorders, neurodevelopmental disorders, neurocognitive disorders, or depressive disorders due to substances and/or medications, depressive disorders due to other medical problems, etc.);
- •Patients with a cardiac pacemaker, cochlear implant, or other metal foreign body and any electronic equipment implanted in the body, patients with claustrophobia and other contraindications to magnetic resonance scanning, and patients with contraindications to rTMS treatment;
- •Patients with serious or unstable diseases of the cardiovascular, liver, kidney, blood, endocrine, neurological system, and other systems or organs, especially those with organic brain diseases (such as ischemic stroke, cerebral hemorrhage, brain tumor, etc.) and a history of severe brain trauma as judged by the researcher;
- •History of epilepsy (presence of at least 2 uninduced seizures more than 24 hours apart, or diagnosis of the epileptic syndrome, or seizures within the past 12 months); Or currently received medications or other treatments that will lower the seizure threshold;
- •History of ECT, rTMS, VNS, DBS, tDCS, light therapy, or other physical therapy related to mental illness within 3 months;
- •Currently receiving or planning to start formal cognitive or behavioral therapy, or systemic psychological therapy (interpersonal therapy, dynamic therapy, cognitive behavioral therapy, etc.) during the trial.
- •Substance abuse or dependence (including alcohol, drugs, and other psychoactive substances) in the past 1 year;
- •The female of childbearing potential who plans to become pregnant during the trial, and that is pregnant or breastfeeding.
- •Patients in any clinical trials of other drugs or physical therapy within 1 month before the screening.
- •First-degree relatives have bipolar affective disorder.
- •Difficulty or inability to engage in normal communication, understand or follow instructions, and cooperate with treatment and evaluators.
- •Investigators think that was inappropriate to participate.
结局指标
主要结局
change in Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: Baseline, Day 5
The 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 Digit Symbol Substitution Test (DSST)(Baseline, Day 5 (Immediate Post-treatment))
- cognitive change in Trail-Making Test (TMT)(Baseline, Day 5 (Immediate Post-treatment))
- Safety estimated using SSI(Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment)
- Change in Hamilton Depression Scale (HAMD-17)(Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment)
- Change in MADRS(Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment)
- cognitive change in continuous performance test (CPT)(Baseline, Day 5 (Immediate Post-treatment))
- Safety estimated using YMRS(Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment)
- Change in Quick Inventory of Depressive Symptomatology Self-Report (QIDS_SR)(Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment)
- cognitive change in Digit Span Test (DST)(Baseline, Day 5 (Immediate Post-treatment))