Controlled Randomized Non-comparative Trial Assessing Active Transcranial Direct Current Stimulation [tDCS] on Left Dorsoleteral Prefrontal Cortex Versus Active tDCS Active on Right Orbitofrontal Cortex to Treat Unipolar Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- BSS scores
研究概览
简要总结
The study aims at investigating if tDCS applied to left DLPFC or to right OFC to treatment as usual is effective in reducing severe suicidal ideas in major depressive episode.
详细描述
Depressive disorders are one of the most frequent pathologies in psychiatry. The lifetime prevalence of the characterized depressive episode is indeed particularly high, between 16.6% in the United States and 24.1% in France. Because of this high prevalence, and because they constitute a pathology with a high risk of suicidal behavior (SC), depressive disorders are a major target of medical strategies for suicide prevention. In addition to suicidal ideation, impulsivity, considered as the tendency to express spontaneous, excessive and/or unplanned behaviors, is recognized as being a major factor precipitating SCs.
With a pilot, prospective, multicenter design, the perspectives of DEPIMPULSE include being able to develop an innovative therapeutic approach in the reduction of risky behaviors, in particular suicidal ideation, associated impulsivity, suicidal risk in patients suffering from depression, while improving our understanding of the behavioral aspects and associated cognitions.
The treatment will be delivered during 5 consecutive days (D1 to D5).
Baseline measures (D0) will be compared to those obtained after the treatment administration (last day of treatment (D5) and 2 weeks (+W2) and 1 month (+W4) after the end of treatment.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Man or woman older than 18 years oldRight-handed
- •Signed Informed Consent form
- •Subject affiliated to or beneficiary from a French social security regime
- •Inpatient or outpatient at the Adult Psychiatry Service
- •Diagnosis of Major Depressive Disorder according to the 5th edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria and confirmation by the MINI Structured Clinical Interview
- •MADRS score ≥ 18
- •Beck Scale for Suicide Ideation (BSS) score ≥8
- •Under antidepressant treatment
- •Absence of severe progressive neurologic and/or somatic pathologies (specially tumors, degenerative diseases)
排除标准
- •tDCS contraindication
- •Younger than 18 years old
- •Left-handed
- •under mood stabilizer and/or antiepileptic
- •treated by ECT or rTMS or tDCS for the current eposide
- •Subject under measure of protection or guardianship of justice
- •Presence of other psychiatric pahtologies
- •Subject beneficiary from a legal protection regime
- •Subject unlikely to cooperate or low cooperation stated by investigator
- •Subject not covered by social security
- •Pregnant woman
- •Subject being in the exclusion period of another study or provided for by the "National Volunteer File"
结局指标
主要结局
BSS scores
时间窗: Baseline (Day 0), Day 5 (D5)
Difference of Beck's Scale for Suicide Ideation \[BSS\] score between Day 0 and Day 5, and between the arm active tDCS on left DLPFC and the arm active tDCS on right COF. This scale contains 19 items to assess the risk level for suicide among general population. French version of this scale is designed for autovaluation. Each item is quoted from 0 (no suicidal thoughts) to 2 (high degrees of suicidal intent).
次要结局
- BSS scores(Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS)
- C-SSRS scores(Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS)
- UPPS scores(Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS)
- Severity of depressive symptoms evaluated by the clinician(Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS)
- BIS-10 scores(Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS)
- BART scores(Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS)
- Severity of depressive symptoms evaluated by the patient(Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS)
- Delay discounting with MCQ scores(Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS)
- Psychological and Physical Pain-Visual Analogic Scale (PPP-VAS)(Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS)
- Cognitive assessment(Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS)
- Quality of life measured with the EQ-5D-5L(Baseline (Day 0), Day 5 (D5), Week 2(+W2) and Week 4 (+W4) post-tDCS)