Efficacy and Safety of Accelerated Intermittent Theta-burst Stimulation (a-iTBS) in Adolescents With Depressive Disorder: A Randomized, Double-Blind, Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in CDRS-R (Children's Depression Rating Scale) scores from baseline
研究概览
简要总结
This study aims to assess the feasibility, safety, acceptability, and preliminary efficacy trends of a Accelerated Intermittent Theta-burst Stimulation (a-iTBS) intervention for adolescent depression through a pilot clinical trial. The findings will inform the design and optimization of subsequent formal randomized controlled trials, providing essential evidence for their execution.
详细描述
This study is a randomized, double-blind, controlled pilot trial aimed at evaluating the feasibility, safety, acceptability, and preliminary efficacy trends of Accelerated Intermittent Theta-burst Stimulation (a-iTBS) for the treatment of adolescent depression.
Adolescents diagnosed with Major Depressive Disorder (MDD) will be randomly assigned in a 1:1:1 ratio to one of three groups: the experimental target a-iTBS treatment group, the conventional target a-iTBS treatment group, and the sham stimulation group. All three groups will receive 10 consecutive days of a-iTBS stimulation (5 Hz, 90% RMT) or sham stimulation intervention, using the Blackdolphin TMS Robot (SLD-YXRJ) by Xi'an Solide Brain Modulation Ltd. Co., with 50 sessions in total. The intervention frequency and procedure will remain consistent across all groups.
In the experimental target a-iTBS treatment group, participants will undergo MRI-guided identification of the left dorsolateral prefrontal cortex (DLPFC) region, where the voxel most negatively correlated with the functional connectivity of the subgenual anterior cingulate cortex (sgACC) will serve as the stimulation target. In the conventional target a-iTBS treatment group, participants will have the standard F3 target in the DLPFC identified via MRI guidance as the stimulation site. Participants in the sham stimulation group will receive a placebo treatment, simulating the a-iTBS procedure without generating an effective magnetic field output.
The primary outcome of the treatment phase is the efficacy rate or the remission rate of depressive symptoms. Secondary outcomes include symptom scales, anxiety symptoms, suicide risk, quality of life, sleep, rumination, and cognition. Safety will be monitored through adverse events, vital signs, laboratory tests, and tolerability assessments.
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
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Age 12 - 18 (2) Diagnosis of major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed through the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime version (K-SADS-PL), currently in a depressive episode (3) Score≥40 on the CDRS-R (4) Stable pharmacological treatment: At least 4 weeks of stable psychiatric medication use prior to enrollment, with continuation of the same psychiatric medication regimen throughout the study.
排除标准
- •Psychiatric comorbidities other than anxiety disorders
- •Depression with psychotic symptoms
- •Young Mania Rating Scale (YMRS) score >13
- •A history of neurological disorders (e.g., epilepsy, brain injury) or severe somatic diseases (e.g., thyroid disorders, lupus, diabetes, pulmonary, hepatic, or renal impairment, major trauma)
- •Patients currently using anticonvulsants or high-dose benzodiazepines
- •A history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or other neuromodulation treatments
- •A history of alcohol or substance abuse or dependence
- •Women who are pregnant or breastfeeding
- •Current high suicide risk
- •Potential complicating factors related to transcranial magnetic stimulation, such as scalp conditions or perforations that may affect magnetic field delivery
- •Contraindications to MRI -
研究组 & 干预措施
Experimental target a-iTBS treatment group
Participants will undergo MRI-guided identification of the voxel in the left dorsolateral prefrontal cortex (DLPFC) that is most negatively correlated with the functional connectivity of the subgenual anterior cingulate cortex (sgACC) as the stimulation site. Accelerated Intermittent Theta-burst Stimulation (a-iTBS) (5 Hz, 90% RMT) will be administered using the Blackdolphin TMS Robot device (model SLD-YXRJ) by Xi'an Solide Brain Modulation Ltd. Co., with 50 sessions over 10 consecutive days.
干预措施: Experimental target a-iTBS treatment (Device)
Conventional target a-iTBS treatment group
Participants will undergo MRI-guided identification of the standard F3 target in the dorsolateral prefrontal cortex (DLPFC) as the stimulation site. Accelerated Intermittent Theta-burst Stimulation (a-iTBS) (5 Hz, 90% RMT) will be administered using the Blackdolphin TMS Robot device (model SLD-YXRJ) by Xi'an Solide Brain Modulation Ltd. Co., with 50 sessions over 10 consecutive days.
干预措施: Conventional target a-iTBS treatment (Device)
Sham stimulation treatment group
Participants will receive a sham stimulation treatment designed to simulate the a-iTBS procedure without generating an effective magnetic field output. The intervention will use a dedicated sham stimulation coil, which is identical in appearance, operation, and stimulation protocol to the experimental group. This coil is designed to maintain the same auditory and tactile sensations as the active stimulation but is equipped with an electromagnetic shielding structure or an internal reverse coil arrangement to effectively prevent magnetic flux from penetrating the skull, ensuring no actual neuromodulatory effects.
干预措施: Sham stimulation treatment (Device)
结局指标
主要结局
Change in CDRS-R (Children's Depression Rating Scale) scores from baseline
时间窗: Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months
Response rate of depressive symptoms (defined as ≥50% reduction in CDRS-R score) or remission rate of depressive symptoms (defined as CDRS-R score ≤28). The CDRS-R scale ranges from 0 to 54, with higher scores indicating worse depressive symptoms.
次要结局
- Change in BDI-II (Baker Depression Scale) scores from baseline(Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months)
- Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) scores from baseline(Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months)
- Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale)(Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months)
- Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline(Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months)
- Change in PedsQL4.0 (The Pediatric Quality of Life Inventory) scores from baseline(Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months)
- Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline(Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months)
- Change in CGI-I (Clinical Global Impressions-Improvement Scales) scores from baseline(Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months)
- Change in RSS (Ruminative Responses Scale)(Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months)
研究者
Xinyu Zhou
professor
First Affiliated Hospital of Chongqing Medical University