NCT06477276已完成不适用
A Multicenter, Randomized, Controlled, Double-Blind Trial on the Efficacy and Safety of Amygdala Temporal Interference Stimulation for the Treatment of Depression.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 3
- 主要终点
- Quick Inventory of Depressive Symptomatology - Self-Report (16-item version)
研究概览
简要总结
The current investigation employs a directed neuromodulation technique, specifically targeting the right amygdala, to ascertain its therapeutic efficacy in managing depressive episodes. The intervention's safety and efficacy will be evaluated using an assessment incorporating depressive symptomatology, cognitive abilities, and daily functions.
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, Investigator)
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
- •Participants must be aged between 18 and 65, with no gender restrictions;
- •A diagnosis of depression made by the study physician based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
- •HAMD-17 score of 17 or higher;
- •Participants must not have changed their antidepressant medication regimen from 30 days prior to signing the informed consent form through the duration of the experiment;
- •Eligible individuals or their authorized representatives must demonstrate, as assessed by the study physician, a comprehensive understanding of the study's objectives and procedures, be capable of adhering to the requirements set forth in the study protocol and provide their signature on the informed consent form.
排除标准
- •Eligible participants must not have a history of psychiatric disorders such as schizophrenia, as judged by the investigator, which may impact the evaluation of the study's efficacy;
- •Participants must not have a history of seizures or prior episodes of epilepsy;
- •The presence of metallic foreign objects within the cranial structure or metallic cardiac implants;
- •Participants must not have a diagnosis of organic brain disease nor a history of significant cranial trauma or neurosurgical intervention;
- •Participants received electroconvulsive therapy or other physical therapies (such as transcranial magnetic stimulation therapy);
- •The researcher evaluated the individual's mental state and determined it to present a significant risk of suicidal ideation or behavior;
- •Pregnant or breastfeeding;
- •Participants who are concurrently engaged in other clinical interventional trials;
- •Participants presenting with other circumstances that the investigator deems unsuitable for the intervention being studied.
结局指标
主要结局
Quick Inventory of Depressive Symptomatology - Self-Report (16-item version)
时间窗: 4 weeks
次要结局
- Hamilton Depression Rating Scale (17-item version)(Baseline, 1 week, 4 weeks and 8 weeks)
- Quick Inventory of Depressive Symptomatology - Self-Report (16-item version)(Baseline, 1 week and 8 weeks)
- Snaith-Hamilton Pleasure Scale(Baseline, 1 week, 4 weeks and 8 weeks)
- Hamilton Anxiety Rating Scale(Baseline, 4 weeks and 8 weeks)
- Pittsburgh Sleep Quality Index(Baseline, 4 weeks and 8 weeks)
- 36-Item Short Form Health Survey(Baseline and 8 weeks)
- World Health Organization Quality of Life Assessment - Brief Version(Baseline and 8 weeks)
研究者
ZHANG CHENCHEHG
Clinical Neuroscience Center Deputy Director
Ruijin Hospital
研究点 (3)
Loading locations...
相似试验
已完成
不适用
Transcranial Direct Current Stimulation (tDCS) in the Treatment of Major Depressive Disorder (MDD)Major Depressive DisorderNCT01078948Centre for Addiction and Mental Health24
已完成
不适用
STEM-Parkinson's DiseaseParkinson's Disease and ParkinsonismParkinson DiseaseNCT04797611Scion NeuroStim188
招募中
不适用
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual DysfunctionNeurogenic Dysfunction of the Urinary BladderSacral NeuromodulationBowel DysfunctionQuality of LifeMultiple SclerosisSexual DysfunctionNCT05380856Odense University Hospital60
已完成
3 期
NeuroAiD II™ (MLC901) in Mild Traumatic Brain InjuryTraumatic Brain InjuryNCT04861688Moleac Pte Ltd.182
招募中
不适用
Spinal Cord Stimulation and Small Fiber Peripheral NeuropathyDiabetic Peripheral NeuropathyNCT06287736Ohio State University60