Added Value of a Neuroendocrine Test Battery in the Response to Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment : a Pilot Study in Major Depression (Endo-rTMS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 17-item Hamilton Depression Scale (HAMD)
研究概览
简要总结
The primary objective of the study is to determine the predictive value of the neuroendocrine tests TRH-∆∆TSH (thyreoliberin - thyreostimulin) and DST (dexamethasone suppression test) in the subsequent response to rTMS-TBS (repetitive transcranial magnetic stimulation-theta burst stimulation) treatment, defined as at least a 50% decrease in depression score after 20 sessions of rTMS-TBS.
详细描述
Conduct of research :
This is a monocentric, non-randomized, open-label pilot study involving 50 male and female patients aged 18 to 65, hospitalized for major depression and presenting with an indication for treatment with repeated theta-burst transcranial magnetic stimulation (rTMS-TBS), i.e. a situation of therapeutic failure following 2 well-conducted antidepressant treatments.
At the end of the 20 rTMS-TBS sessions (one session per day, except weekends), the clinical response will be assessed by an investigator "blind" to the endocrine results. This response will be analyzed according to the status of neuroendocrine tests at inclusion (TRH-∆∆TSH and DST) and at the end of the study (for those who had one or more abnormal tests at inclusion and in whom the same tests were repeated at the end of the rTMS-TBS sessions).
During the inclusion visit, the patient and investigator sign the consent form, after double-checking the inclusion and non-inclusion criteria.
Immediately after the tenth rTMS session, an assessment of depression using the HAMD (17-item Hamilton Depression Scale) scale will be carried out by an independent psychiatrist, blind to the results of the neuroendocrine tests. This psychiatrist, who has already administered the HAMD at V0, will repeat the assessments at V1 and V2.
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
- •Patient with a characterized depressive episode defined according to DSM-5 (diagnostic and statistical manual of mental disorders) criteria;
- •Patient between the ages of 18 and 65 years;
- •Inpatient with an inadequate response to two prior well-conducted antidepressant treatments (Hamilton 17-item scale [HAMD-17] score at inclusion≥ 18) ;
- •Patient with written informed consent to participate in the study;
- •Patient enrolled in or receiving social security benefits.
排除标准
- •Patient with endocrinopathy ;
- •Patient with a contraindication to neuroendocrine testing (hypersensitivity to the active substance or to one of the excipients);
- •Patient with a contraindication to rTMS:
- •cochlear implant,
- •cardiac pacemaker,
- •metal clips, stents or other electronic implants within one meter of the stimulation coil,
- •intracranial hypertension,
- •poorly balanced comitiality,
- •in the case of well-balanced comitiality, a neurological consultation with electroencephalogram (EEG) is planned before including the patient;
- •Patient previously treated with monoamine oxidase inhibitor (MAOI) antidepressant or lithium salts (within 6 months prior to inclusion);
- •Pregnant or lactating patient;
- •Patient under court protection or deprived of liberty;
- •Patient under guardianship/guardianship.
研究组 & 干预措施
Treatment resistant major depressed inpatients (TRDs)
干预措施: Repetitive transcranial magnetic stimulation (rTMS) (Procedure)
结局指标
主要结局
17-item Hamilton Depression Scale (HAMD)
时间窗: Change from inclusion result at 6 weeks (after 20 rTMS-TBS sessions)
Clinical response will be defined by at least a 50% decrease in depression score at the end of the 20 rTMS-TBS sessions - measured by the 17-item Hamilton Depression Scale (HAMD) - compared to inclusion (Carrozzino et al, 2020). The predictive value of the TRH-∆∆TSH on the one hand, and the DST on the other, will be assessed using an ROC curve and its AUC (Area Under the Curve) calculation.
次要结局
- Evolution of neuroendocrine parameters(Through study completion, an average of 6 weeks)
- Relationship of the therapeutic response with the evolution of neuroendocrine parameters(Through study completion, an average of 6 weeks)
- Predictive factors(Through study completion, an average of 6 weeks)
- Hamilton Depression Scale (HAMD)(Through study completion, an average of 6 weeks)