Clinical, Cognitive and Neural Effect of Potentiation of Electroconvulsive Therapy (ECT) by Repetitive Transcranial Magnetic Stimulation (rTMS) at 10 ECT in Patients With Characterized Pharmacoresistant Depressive Episode
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Response rate after 10 ECT
研究概览
简要总结
Electroconvulsive therapy (ECT) is one of the most effective treatments for treatment-resistant depression (TRD). However, due to response delay and cognitive impairment, ECT remains an imperfect treatment. In this multicenter, randomized, double-blind, sham-controlled study, our objective is to assess the priming effect of rTMS sessions before ECT on clinical, cognitive and neural response in patients with TRD.
详细描述
80 patients with TRD will be assigned to active or sham rTMS before ECT treatment. Five sessions of active/sham rTMS will be administered over the left dorsolateral prefrontal cortex (20 Hz, 90% resting motor threshold, 20 2 s trains with 60-s intervals, 800 pulses/session) before ECT (which was active for all patients) started. Then, from the sixth ECT session, an rTMS session will occur the day before each ECT session. Clinical assessment, cognitive assessment and brain imaging (structural MRI, resting state functional MRI, MR spectroscopy) will take place before and after 10 ECT sessions. Clinical, cognitive and neural changes will be compared between both groups after 10 ECT sessions.
The primary outcome will be the response rate after 10 ECT, i.e. the percentage of patients who achieved a reduction of 50% or more from their initial Hamilton Depression Scale score (HAMD-21 items).
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Major Depressive Disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria
- •HAMD score ≥15
- •In case of unipolar disorder: no remission after at least two different antidepressants prescribed at a dose and duration sufficient for the current episode
- •In the case of bipolar disorder: no remission despite lithium at an adequate plasma level combined with lamotrigine or quetiapine monotherapy at full dose
- •No change of antidepressant or mood stabilizer treatment for at least 15 days
- •To be rTMS-naive
- •Without benzodiazepine or antiepileptic treatment for at least 15 days
- •To understand spoken and written French
- •Having given their informed, written consent
排除标准
- •Contraindication to Electroconvulsive therapy (ECT), repeated Transcranial Magnetic Stimulation (rTMS), Magnetic Resonance Imaging (MRI), anesthesia
- •Patients who have received ECT in the last 6 months
- •Patients suffering from poorly stabilized epilepsy, serious neurological or systemic disorders
- •Patients with a serious substance use disorder (other than nicotine or caffeine) according to DSM-5 criteria
- •Patients suffering from severe hearing problems
- •Subjects already treated with an electrical or magnetic stimulation technique
- •Women who do not have adequate contraception, pregnant or breastfeeding women
- •Being deprived of liberty by an administrative or judicial decision
- •Patients participating or having participated in an interventional clinical trial within 30 days before the inclusion visit
结局指标
主要结局
Response rate after 10 ECT
时间窗: Day 0 and Day 40
the percentage of patients who achieved a reduction of 50% or more from their initial Hamilton Depression Scale score (HAMD-21 items)
次要结局
- The relative improvement of depressive symptoms throughout the study (self-reported)(Day 0, Day 4, Day 19, Day 26, Day 40)
- Brain activity and biochemical changes(Day 0 and Day 40)
- Attention (objective)(Day 0 and Day 40)
- Autobiographical memory (objective)(Day 0 and Day 40)
- Dose of medication(Day 5, Day 9, Day 11, Day 16, Day 18, Day 23, Day 25, Day 30, Day 32, Day 37)
- Global cognitive functioning (objective)(Day 0 and Day 40)
- Seizure threshold(Day 5, Day 9, Day 11, Day 16, Day 18, Day 23, Day 25, Day 30, Day 32, Day 37)
- Changes in regional gray matter density(Day 0 and Day 40)
- Changes in cortical thickness(Day 0 and Day 40)
- The relative improvement of depressive symptoms throughout the study (assessed by a clinician)(Day 0, Day 4, Day 19, Day 26, Day 40)
- Adverse effects(Day 4, Day 19, Day 26, Day 40)
- Subjective assessment of cognitive functioning(Day 4, Day 19, Day 26, Day 40)
- Verbal memory performances (objective)(Day 0 and Day 40)
- Postictal Suppression(Day 5, Day 9, Day 11, Day 16, Day 18, Day 23, Day 25, Day 30, Day 32, Day 37)
- Subjective assessment of memory(Day 4, Day 19, Day 26, Day 40)
- Visuospatial and constructional ability (objective)(Day 0 and Day 40)
- Seizure duration(Day 5, Day 9, Day 11, Day 16, Day 18, Day 23, Day 25, Day 30, Day 32, Day 37)
研究者
Maud Rothärmel
Principal investigator
Centre Hospitalier du Rouvray