NCT07510880招募中不适用
Home tDCS for the Treatment of Major Depression: A Randomised Clinical Trial
Ionclinics & Deionic SL3 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2026年4月14日最近更新:
适应症
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
- 198
- 试验地点
- 3
- 主要终点
- MADRS
研究概览
简要总结
The purpose of this multicentric randomized controlled trial is to compare the effectiveness and safety of home-based tDCS for the treatment of major depression versus tDCS treatment in a healthcare centre, and explore the effects of an accelerated home-tDCS protocol.
The change in depression index at the end of treatment, measured with MADRS, will be the primary outcome.
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
Although it is impossible to blind participants due to the nature of the study, the evaluator and statistician will be blinded.
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
- •Spanish or Catalan speakers of both sexes between the ages of 18 and
- •Patients diagnosed with major depression, based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Specifically, patients will be included who meet the criteria for a major depressive episode with a longitudinal diagnosis of major depressive disorder, single or recurrent episode; or bipolar disorder type 1 or
- •Patients must obtain a moderate or higher score, therefore we establish a lower limit of 15 points on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Alonzo et al., 2019).
- •Patients receiving or not receiving pharmacological treatment for depression will be included, and this will be recorded as an additional variable.
- •Have the ability and willingness to commit to the study team for supervision of the intervention sessions and close monitoring of safety.
- •Demonstrate the acquisition of the ability to properly apply home tDCS independently or with the help of a companion.
排除标准
- •Patients with psychotic, schizoaffective, or personality disorders (both cluster A and B).
- •Patients with a history of neurological disease, intellectual disability, or cognitive impairment (inability to understand instructions or operate equipment).
- •Any exclusion criteria 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 in the last 6 months. Clinical or family history of epilepsy.
- •Patients with dermatological problems, such as an allergic skin reaction at the electrode site.
- •High risk of suicide. Assessed through an interview with a psychiatrist and the use of the Spanish-validated Columbia Suicide Risk Scale (C-SSRS) (Al-Halabí et al., 2016).
- •Drug or alcohol abuse during the study or in the previous 3 months (except for nicotine).
- •Changes in pharmacological or non-pharmacological treatment (such as structured psychotherapy) during the study or in the 3 months prior to starting the trial.
- •Pregnancy.
研究组 & 干预措施
Accelerated home tDCS
Experimental
Home tDCS applied over 3 weeks (42 sessions)
干预措施: Accelerated protocol of home Transcranial direct current stimulation (Device)
Conventional home tDCS
Active Comparator
Home tDCS applied over 9 weeks (42 sessions)
干预措施: Conventional protocol of in person Transcranial direct current stimulation (Device)
Conventional ambulatory tDCS
Active Comparator
Ambulatory tDCS applied over 9 weeks (42 sessions)
干预措施: Conventional protocol of home Transcranial direct current stimulation (Device)
结局指标
主要结局
MADRS
时间窗: End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.
Mean score change based on Montgomery-Asberg Depression Rating Scale (MADRS) of the three arms at the end of the treatment compared to baseline.
次要结局
- MADRS(2nd week of treatment.)
- MADRS(3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.)
- HDRS-17(End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.)
- HDRS-17(2nd week of treatment.)
- HDRS-17(3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.)
- HARS(End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.)
- HARS(2nd week of treatment.)
- HARS(3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.)
- PHQ9(End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.)
- PHQ9(2nd week of treatment.)
- PHQ9(3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.)
- Clinical Global Impression(End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.)
- Clinical Global Impression(2nd week of treatment.)
- Clinical Global Impression(3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.)
研究者
研究点 (3)
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