Pilot Study on the Identification of Cortical Excitability Changes Measured by Transcranial Magnetic Stimulation (TMS) as Markers of Antidepressant Response
试验速览
- 阶段
- 不适用
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Variation of the CSP between day 1 and day 28
研究概览
简要总结
Depression is a common issue but there is no marker of response to an antidepressant treatment.The measurement of variation of the cortical excitability in responders to a selective serotonin reuptake inhibitor (SSRI) (compared to no-responders) had never been done before. In the study of Robol et al. (2004) concerning the acute effects of citalopram on markers of cortical excitability, the authors have pointed out an increase on the cortical silent period (CSP) after administration of citalopram (2.5 hours). The investigators hypothesize that this effect remains later and that the diminution of cortical excitability could be a biomarker of antidepressant response. In this case, they expect that the variation of CSP between day 1 and day 28 is higher in responders to a SSRI (citalopram) compared to non-responders. the investigators lead a pilot, prospective, multicentric study in drug-naive patients to compare the variation of the markers of cortical excitability (the CSP but to the resting motor threshold RMT, the motor evoked potential MEP, the intra-cortical inhibition ICI and the intra-cortical facilitation ICF) between day 1 and day 28 in responders to citalopram, compared to non-responders.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •major depressive episode (according to DSM 5 criteria). Severity of depressive episode assessed by Hamilton Depressive Rating Scale 21 items (HAMD-21) : score > 15 (significant impairment), low suicide risk (score < 2 on suicide item).
- •Drug-naive patient (or antidepressant stopped for more than 3 months).
- •Patient covered by security social system.
- •Patient who is able to read and understand the information paper. Patient who is able to sign the consent.
- •For women of childbearing age, effective method of contraception (estrogen-progestin contraceptive or intra-uterine device or tubal ligation) for more than 1 month (negative pregnancy test).
排除标准
- •Coprescription of psychoactive or neurological drugs known to alter cortical excitability
- •Other psychiatric disorders (psychotic disorders, eating disorders).
- •Change of antidepressive drug during the study.
- •Abuse or addiction at other substances than nicotine or caffeine.
- •Unsteady consumption of nicotine or caffeine.
- •Dermatologic disease, dementia, medical history of seizure or epilepsy, brain tumor, metallic biomedical implants in brain.
- •Ongoing treatment by magnetic or electric stimulation (for example : transcutaneous nerve stimulation or spinal cord stimulation).
- •Women of childbearing age without effective contraception, pregnant or breastfeeding.
- •Patient who was already included in a clinical trial within 30 days before the inclusion visit.
- •Patient deprived of liberty and under guardianship.
研究组 & 干预措施
Treatment by citalopram
The patients will receive a treatment by citalopram at 20mg/day. If patients respond by at least 20% on the HAMD-21 scale at day 14 : continuation at 20 mg/day. If patients do not respond by at least 20% at day 14 : increase the dose at 40 mg/day. The patients who will not respond by at least 50% on the HAMD-21 scale at day 28 will be excluded of the study and will undergo a new treatment plan. The patients who will respond by at least 50% on HAMD-21 at day 28 will continue citalopram at the same dose and will be reappraised at day 60. The patients will be assessed for the markers of neuroexcitability at day 1, day 3, day 7, day 14, day 28 and day 60.
干预措施: Measurements of markers of cortical excitability by TMS (Device)
结局指标
主要结局
Variation of the CSP between day 1 and day 28
时间窗: 28 days
The difference in variation of the cortical silent period (CSP) between day 1 and day 28 in responders compared to non-responders. A decrease by at least 50% on Hamilton Depression rating Scale (HAMD-21) define response to citalopram.The HAMD-21 assesses the intensity of the depressive symptoms with 21 items. Its score is between 0 (no depression) and 73 (the maximum of intensity).
次要结局
- Variations in UKU (Udvalg pour Kliniske Undersøgelser Side Effect Rating Scale) at different times(60 days)
- Variations in Morisky compliance scale(60 days)
- Variation of the RMT between day 1 and day 28(28 days)
- Variation of the MEP between day 1 and day 28(28 days)
- Variation of the ICI between day 1 and day 28(28 days)
- Variation of the ICF between day 1 and day 28(28 days)
- Variation of the markers of cortical excitability at other times(14 days)
- Variation in HAMD-21 between day 1 and day 60 for the responders at day 28(60 days)