NCT07611773招募中不适用
Clinical Efficacy of tDCS in Major Depression: A Controlled Clinical Trial and Analysis of Electrophysiological Biomarker Predictors
Ionclinics & Deionic SL1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2026年6月14日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 270
- 试验地点
- 1
研究概览
简要总结
The purpose of this randomized controlled trial is to investigate the non-inferiority, and possible superiority, of a high-dose home-based tDCS protocol compared with a conventional home-based protocol, and to assess its cost-effectiveness, in patients with major depression.
As a secondary aim, we aim to assess the predictive value of baseline EEG for clinical response to high-dose home-based tDCS treatment in patients with major depression.
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 (Investigator, Outcomes Assessor)
盲法说明
EEG analyst will be blinded from group treatment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or over.
- •Patients diagnosed with Major Depressive Disorder with a current depressive episode, based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (American Psychiatric Association, 2013).
- •Score on the Hamilton Depression Rating Scale (HDRS-17) ≥16 (Hamilton et al., 1960).
- •Patients on a stable prescription of antidepressants/pharmacological medication and who agree to continue this throughout the study; and/or, if undergoing psychotherapy, who have maintained this treatment consistently for at least 6 weeks.
- •Demonstrate the ability to apply home-based tDCS appropriately, either independently or with the help of a carer.
- •Have access to an electronic device with a camera to enable monitoring of the intervention, as well as to contact the participant.
- •Have the ability and willingness to commit to the study team to complete all phases of the study.
- •Volunteer to participate and sign the specific informed consent form for this study.
排除标准
- •Patients with a current manic episode as determined by the Young Mania Rating Scale (YMRS), or a psychotic episode as defined by the MINI scale.
- •Patients who answer 'yes' to questions 4, 5 or 6 of the Columbia Suicide Severity Rating Scale (C-SSRS), a risk assessment and identification tool.
- •Patients with treatment-resistant depression, defined as an inadequate clinical response to two or more courses of antidepressant treatment at appropriate doses and duration.
- •Any previous hospitalisation for suicidal behaviour.
- •Presenting with current chronic or severe insomnia (< 4 hours' sleep per night) or sleep apnoea.
- •Presence of any structural lesion (e.g., any structural neurological condition or more subcortical lesions than would be expected for their age, or having suffered a stroke affecting the stimulated area or connected areas) or any other clinically significant abnormality that may affect safety, participation in the study, or confound the interpretation of study results, as determined by the investigator.
- •History or presence of any other condition or comorbidity associated with TDM: cardiac or neurological conditions, cognitive impairment.
- •History of or current diagnosis of any other mental disorder: obsessive-compulsive disorder, bipolar disorder (type 1 or 2), anxiety disorder, agoraphobia, eating disorders, personality disorders.
- •Any exclusion criteria other than those established by clinical guidelines on non-invasive brain stimulation (Woods et al., 2016):
- •Metal implants or head injuries, any electronic devices such as cochlear implants or cardiac pacemakers
- •Brain stimulation within the last 6 months.
- •Clinical or family history of epilepsy or seizure episodes.
- •Presence of dermatological problems (allergic skin reaction at the electrode site, psoriasis, etc.)
- •History of drug or alcohol abuse during the study or in the 3 months prior (with the exception of nicotine).
- •Pending trial or litigation during the course of the trial.
- •Pregnancy.
研究组 & 干预措施
High-dose home-tDCS
Experimental
干预措施: High-dose home-tDCS (Device)
Conventional home-tDCS
Active Comparator
干预措施: Conventional home-tDCS (Device)
研究者
研究点 (1)
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