NCT06009523招募中不适用
Effects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation in Treatment-resistant Depression : a Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from Baseline in suicidal ideation on the Scale for Suicide Ideation (SSI) at "Day 19"
研究概览
简要总结
The main objective of this study is to demonstrate that 15 transcranial direct current stimulation (tDCS) sessions of 30 minutes at 2 mA intensity are effective to reduce suicidal ideation
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening visit to determine eligibility for study entry. Patient who meet the eligibility requirements be able to start the 15 tDCS sessions at the rate of one session per day. After the last session, patients will perform three follow-up visits on D19, D49 and D79
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age over 18 years
- •Written informed consent
- •Diagnosis of recurrent or isolated depressive episode according to DSM IV criteria (A.P.A. 1994).
- •Stable antidepressant treatment for 3 weeks
- •MADRS score ≥ 20
- •SSI score > 3
- •Subject affiliated to a health insurance system
- •Woman with effective contraception and agreeing to maintain it throughout the study period.
排除标准
- •Depression with psychotic features Axis I (DSM IV) co-morbid diagnosis of schizophrenia, alcohol and/or other substance dependence (or abuse) (lifetime)
- •Patient who has already undergone an electroconvulsive therapy course for the current episode and does not respond to this treatment
- •Patient deprived of liberty
- •Patient with high suicide risk (item 10 MADRS > 4) in the absence of hospitalization
- •Contraindication to tDCS: intracerebral metallic implant (with the exception of dental implants), cardiac pacemaker, active or non-implanted devices in the region of the head, acute eczema in the planned stimulation area
- •Pregnant, parturient or breastfeeding woman
- •Simultaneous participation in another interventional research
结局指标
主要结局
Change from Baseline in suicidal ideation on the Scale for Suicide Ideation (SSI) at "Day 19"
时间窗: Baseline and "Day 19"
The main judgment criterion is the evolution of suicidal ideation which is evaluated by the Beck Scale for Suicide Ideation (SSI) between Baseline and "Day 19"
次要结局
- Change from Baseline of clinical response defined by the MADRS (Montgomery and Asberg depression scale) at "Day 19" post-tDCS sessions(Baseline and "Day 19")
- Change from Baseline of clinical response defined by the MADRS (Montgomery and Asberg depression scale) at "Day 49" post-tDCS sessions(Baseline and "Day 49")
- Change from Baseline of clinical response defined by the MADRS (Montgomery and Asberg depression scale) at "Day 79" post-tDCS sessions(Baseline and "Day 79")
- Change from Baseline in quality-of-life assessed by the SF36 (Short Form (36) Health Survey) at "Day 19" post-tDCS sessions(Baseline and "Day 19")
- Change from Baseline in quality-of-life assessed by the SF36 (Short Form (36) Health Survey) at "Day 79" post-tDCS sessions(Baseline and "Day 79")
- Change from Baseline in suicidal ideation assessed by the implicit association test at "Day 19" post-tDCS sessions(Baseline and "Day 19")
- Change from Baseline in suicidal ideation assessed by the implicit association test at "Day 49" post-tDCS sessions(Baseline and "Day 49")
- Change from Baseline in quality-of-life assessed by the SF36 (Short Form (36) Health Survey) at "Day 49" post-tDCS sessions(Baseline and "Day 49")
- Change from Baseline in suicidal ideation assessed by the implicit association test at "Day 79" post-tDCS sessions(Baseline and "Day 79")
研究者
研究点 (2)
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