NCT05964023招募中不适用
Personalized Brain Functional Sector-guided rTMS Therapy Targeting DLPFC VS "5-centimeter Rule" for Major Depression
Changping Laboratory4 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年8月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Changes in Montgomery-Asberg Depression Rating Scale (MADRS) scores
研究概览
简要总结
The investigators aim to investigate whether the intervention effect of pBFS-guided rTMS therapy targeting DLPFC is superior to the intervention effect of the traditional "5 cm-rule" guided rTMS therapy in patients with depressive disorders.
详细描述
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 1:1 ratio to the pBFS group, or 5-cm rule group. Then all participants will undergo a 21-day rTMS modulation and 7-day, 14-day, and 45-day post-treatment follow-up visits. Participants will not take any other treatment during the intervention and the 7-day and 14-day post-treatment visits.
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
- •Meet the diagnostic criteria of DSM-5(Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) for the depression disorder without psychotic symptoms, and currently experiencing recurrence episodes.
- •Inpatients or outpatients aged 18-65 years (inclusive), male or female.
- •Total HAMD-17 score ≥20 before randomization.Total MADRS score ≥25 before randomization.
- •Inadequate response to at least one antidepressant trial of adequate doses and duration.
- •Currently not taking any antidepressant medication. If previously medicated, a washout period of 7 days is required.
- •Voluntarily participate in the trial and sign informed consent. Able to comply with the planned visit, examination and treatment plan, and other study procedures.
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 plans to become pregnant during the trial and the female 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.
- •There is a significant risk of suicide (MADRS item 10 ≥ 5).
- •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
Changes in Montgomery-Asberg Depression Rating Scale (MADRS) scores
时间窗: Baseline and Day 21
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
- changes in MADRS(Baseline, Day 7, Day 14, Day 21 (immediate post-treatment), 7-day post-treatment, 14-day post-treatment, 45-day post-treatment)
- cognitive change in Trail-Making Test (TMT)(Baseline, Day 21 (Immediate Post-treatment))
- cognitive change in Digit Span Test (DST)(Baseline, Day 21 (Immediate Post-treatment))
- cognitive change in continuous performance test (CPT)(Baseline, Day 21 (Immediate Post-treatment))
- changes in HAMD(Baseline, Day 7, Day 14, Day 21 (immediate post-treatment), 7-day post-treatment, 14-day post-treatment, 45-day post-treatment)
- cognitive change in Digit Symbol Substitution Test (DSST)(Baseline, Day 21 (Immediate Post-treatment))
研究者
研究点 (4)
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