The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Cerebral Blood Flow from baseline
研究概览
简要总结
The study will apply state of the art radiology through advanced magnetic resonance imaging (MRI) techniques to investigate structural and functional brain effects of electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS).
详细描述
As a multi-disciplinary collaboration, imaging findings will be correlated to psychiatric response parameters, neuropsychological functioning as well as neurochemical and genetic biomarkers that can elucidate the underlying mechanisms. The aim is to document both treatment effects and potential harmful effects of ECT and TMS
Sample, three groups:
ECT: n = 50 patients in a major depressive episode (bipolar and major depressive disorder) who have accepted treatment with ECT.
TMS: n = 50 patients in a major depressive episode (bipolar and major depressive disorder) who have accepted treatment with TMS.
HC: = 50 age and gender matched healthy volunteers not receiving ECT nor TMS.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients (>18) referred to the center of ECT and accepted for treatment
- •because of moderate and severe depression
- •fulfilling the criteria for the following ICD-10 diagnosis: F 31.3 and F31.4; F32.1 and F32.2 and F32.3; F33.1 and F33.2 and F33.
- •In addition, the symptom intensity must be verified by a MADRS score ≥
- •There is no upper age for participation, however, the responsible clinician will consider if patients are eligible for inclusion (functioning, enabled to give informed consent).
- •Patients (>18) referred to the center of TMS and accepted for treatment
- •because of moderate and severe depression
- •fulfilling the criteria for the following ICD-10 diagnosis: F 31.3 and F31.4; F32.1 and F32.2 and F32.3; F33.1 and F33.2 and F33.
- •In addition, the symptom intensity must be verified by a MADRS score ≥
- •There is no upper age for participation, however, the responsible clinician will consider if patients are eligible for inclusion (functioning, enabled to give informed consent).
- •Healthy controls:
- •Age and gender matched (to the patient groups).
- •No history of psychiatric illness and no current depression.
- •No contraindication for MRI scanning.
排除标准
- •ECT / TMS treatment within the last 12 months.
- •Patients unable to give informed consent (according to the responsible clinician or ECT / TMS responsible).
- •Patients who cannot participate in the MR scanning
结局指标
主要结局
Change in Cerebral Blood Flow from baseline
时间窗: Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment)
Estimated by Arterial Spin Labeling MRI
Change in MADRS from baseline
时间窗: Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment)
Depression rating by MADRS score
次要结局
- Changes in functional MRI(Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment))
- Change in performance on test of spatial navigation(Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment))
- Change fraction of in Isotropic hindered water(Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment))
- Changes in structural MRI T1 and T2 and RSI(Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment))
- Change in concentration of NAA, Choline, myo Inositol(Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment))