A Prospective, Multicenter, Randomized, Single-Blind, Exploratory Clinical Trial to Validate the Efficacy and Safety and Predict Treatment Response of a Theta Burst Stimulation Protocol of Repetitive Transcranial Magnetic Stimulation in Treatment-Resistant Depression
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Depressive Symptom Severity
研究概览
简要总结
This study will evaluate the efficacy and safety of a theta burst stimulation (TBS) protocol of repetitive transcranial magnetic stimulation (rTMS) in adults with treatment-resistant depression. Participants will be randomized to either antidepressant treatment plus active rTMS TBS or antidepressant treatment plus sham stimulation for the first 10 sessions followed by active rTMS TBS for the next 10 sessions. The main objective is to compare the change in Hamilton Depression Rating Scale (HAM-D) total score after 10 treatment sessions between groups and to explore predictors of treatment response.
详细描述
This is a prospective, multicenter, randomized, double-blind, exploratory clinical trial evaluating the efficacy and safety of rTMS theta burst stimulation (TBS) in patients with depression.
A total of 120 participants will be enrolled, including 80 adults (≥19 years) with treatment-resistant depression and 40 adolescents (15-17 years) with depressive disorders. Participants will be stratified by age group and randomized in a 1:1 ratio to one of two treatment arms.
In the combined treatment arm, participants will receive antidepressant therapy plus active bilateral sequential TBS (bsTBS) for 20 sessions over approximately 4 to 7 weeks. In the comparator arm, participants will receive antidepressant therapy plus sham stimulation for the first 10 sessions, followed by active TBS for the remaining 10 sessions.
The primary outcome is the change in depressive symptom severity after 10 treatment sessions, measured by HAM-D in adults and age-appropriate scales in adolescents. Secondary outcomes include sleep, cognitive function, global clinical improvement, social functioning, and neuroimaging biomarkers. Safety outcomes include adverse events and suicidal ideation assessments.
This study aims to explore the efficacy of TBS across different age groups and to identify predictors of treatment response.
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
- Double (Participant, Outcomes Assessor)
盲法说明
This is a double-blind study for participants and outcome assessors. Stimulation settings are managed separately by designated personnel according to pre-specified conditions so that participants and assessors remain blinded, particularly through the primary endpoint assessment after 10 treatment sessions.
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥15 years
- •Diagnosis of depressive disorder based on DSM criteria
- •Adults: treatment-resistant depression
- •Adolescents: depressive disorder requiring treatment
- •Moderate or greater depressive symptoms
- •Adults: HAM-D ≥17, MADRS ≥14
- •Adolescents: age-appropriate validated scale (e.g., CDRS-R)
- •Currently receiving or eligible for antidepressant treatment
排除标准
- •Bipolar disorder, schizophrenia, or psychotic disorder
- •Substance use disorder (recent)
- •Neurological disorders (e.g., epilepsy, brain injury)
- •Severe medical illness
- •Metal implants or contraindications to TMS
- •Pacemaker or implanted device
- •Prior rTMS or ECT
- •Pregnancy
- •Any condition deemed unsuitable by investigator
研究组 & 干预措施
Antidepressant + Active rTMS TBS
干预措施: antidepressant therapy (Drug)
Antidepressant + Active rTMS TBS
干预措施: Active rTMS Theta Burst Stimulation (Device)
Antidepressant + Sham then Active rTMS TBS
干预措施: antidepressant therapy (Drug)
Antidepressant + Sham then Active rTMS TBS
干预措施: Sham Stimulation (Device)
结局指标
主要结局
Change in Depressive Symptom Severity
时间窗: Baseline and at 10 treatment sessions (~ 2 weeks)
Change in depressive symptom severity measured by the Hamilton Depression Rating Scale (HAM-D; range 0-52, higher scores indicate more severe depression)
次要结局
未报告次要终点
研究者
Jung-Sun Lee
Professor, Department of Psychiatry
Asan Medical Center