Comparative Effectiveness of Repetitive Versus Deep Transcranial Magnetic Stimulation for Major Depression: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Response (yes/no) on Hamilton Rating Scale for Depression-17
研究概览
简要总结
The goal of this randomized controlled trial is to he effectiveness of two different TMS techniques in TRD, repetitive TMS (rTMS) and deep TMS (dTMS). The main questions it aims to answer are:
type of study: clinical trial participant population/health conditions : Major Depressive Disorder To assess the superiority of dTMS over rTMS in TRD To evaluate the predictive capacity of scalable candidate biomarkers Participants will be randomly allocated to one of the two intervention groups (rTMS or dTMS).
详细描述
The primary aim of this trial is to compare the effectiveness of two different TMS techniques in TRD, repetitive TMS (rTMS) and deep TMS (dTMS). Compared to rTMS, dTMS delivers a broader magnetic field, which in turn reduces coil positioning error and maximizes the probability of optimal cortical stimulation. A past RCT comparing both approaches found a greater depression score decrease and response/remission rates for dTMS, but was short of reaching significance for remission rates (primary outcome). Critical components of this RCT were suboptimal, including too few treatment sessions and insufficient statistical power, both of which could have obscured an actual difference between modalities. Proof of a more effective type of TMS over another would translate into increased odds of improvement for TRD patients who live with a chronic and disabling illness.
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
- Single (Outcomes Assessor)
盲法说明
Given the study's design, blinding participants and TMS operators will not be possible. Still, staff responsible for participant assessments and data analysis will be blinded to treatment conditions and external to the clinic staff. Patients will be instructed not to reveal their group assignment to the raters. Patients will not be given the specifics of the treatment parameters and will be instructed not to talk to each other during the study period. Both treatments will be presented as effective to them. Lastly, the data management center will strictly control access to the randomization code.
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Major Depressive Disorder, at least moderate intensity, single or recurrent episode
- •HRSD-17 score of at least 18
- •No improvement to at least two adequate courses of antidepressants (based on the ATHF) or were unable to tolerate at least two separate trials of antidepressants of inadequate dose and duration
- •On a stable antidepressant regimen for the past four weeks before screening
- •Patients with a chronic depressive episode >2 years and who have previously received ECT or ketamine will be eligible to participate
排除标准
- •Having previously received TMS;
- •Substance use disorder within the last three months
- •Diagnosis of bipolar or psychosis spectrum disorder
- •Anxiety or personality disorder that is assessed by a study investigator to be the primary cause and causing greater impairment than MDD
- •Concomitant major unstable medical or neurological illness
- •Intracranial implant, cardiac pacemaker or implanted medication pump
- •Significant laboratory abnormality;
- •Active suicidal intent
- •Pregnancy
- •If participating in psychotherapy, must have been in stable treatment for at least three months before entry into the study, with no anticipation of change
- •Currently taking more than the equivalent of 2 mg of lorazepam of a benzodiazepine daily or any dose of an anticonvulsant due to the potential to limit TMS effectiveness
结局指标
主要结局
Response (yes/no) on Hamilton Rating Scale for Depression-17
时间窗: baseline to Week 6
Defined as a score reduction of 50% or more
Remission (yes/no) on Hamilton Rating Scale for Depression-17
时间窗: Week 6
Defined as a score of 7 or less
Hamilton Rating Scale for Depression-17 (HRSD-17)
时间窗: Baseline to Week 6
score change. Higher score means worse outcome. (Min = 0, Max = 53)
次要结局
- Response (yes/no) on Hamilton Rating Scale for Depression-17(Baseline to Week 18)
- McLean Screening Instrument for Borderline Personality Disorder(Baseline)
- World Health Organization Quality of Life Short Version (WHOQOL-BREF)(Baseline to Week 6, Week 7, Week 10, Week 18)
- Remission (yes/no) on Hamilton Rating Scale for Depression-17(Baseline to Week 18)
- Hamilton Rating Scale for Depression-28(Baseline to Week 6, Week 7, Week 10, Week 18)
- Quick Inventory of Depressive Symptomatology (self-report) (QIDS-SR 16)(Baseline to Week 6, Week 7, Week 10, Week 18)
- Snaith-Hamilton Pleasure Scale (SHAPS)(Baseline to Week 6, Week 7, Week 10, Week 18)
- Columbia-Suicide Severity Rating Scale (C-SSRS)(Baseline to Week 6, Week 7, Week 10, Week 18)
- Hamilton Rating Scale for Depression-17(Baseline to Week 18)
- General Anxiety Disorder-7 (GAD-7)(Baseline to Week 6, Week 7, Week 10, Week 18)
- Rumination Response Scale (RRS)(Baseline to Week 6, Week 7, Week 10, Week 18)
- Cognitive Difficulties Scale (MacNair-R)(Baseline to Week 6, Week 7, Week 10, Week 18)
- Hamilton Anxiety Rating Scale (HAM-A)(Baseline to Week 6, Week 7, Week 10, Week 18)
- Adult AHDH Self-Report Scale(Baseline to Week 18)
- Memory Complaints Scale (MacNair)(Baseline to Week 6, Week 7, Week 10, Week 18)
- Visual Pain Scale(Each treatment day)
- Sex and Gender scale(Baseline)