Multimodal Magnetic Resonance Imaging-based Study of Electroconvulsive Efficacy Prediction in Adolescents With Depression: a Multicenter Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Changes in CDRS-R (Children's Depression Rating Scale, Revised) scores
研究概览
简要总结
The aim of this project is to investigate the multimodal magnetic resonance brain imaging changes in adolescents with major depressive disorder (MDD) before and after electroconvulsive therapy. Development of a predictive model for the efficacy of electroconvulsive therapy in adolescent MDD.
详细描述
This is a multicenter, prospective, observational study. We will divide the adolescent MDD patients into two groups according to the treatment modality as follows: Group 1 (Modified Electroconvulsive Therapy (MECT), n=60); Group 2 (Non-Modified Electroconvulsive Therapy (Non-MECT), n=60). Patients in group 1 will be treated with MECT according to standard clinical care. Group 2 will receive conventional drug therapy. A healthy control group (n=60) will also be recruited.
The most modern MRI sequences examining brain structure and function are used at 4 time points: at baseline (just before MECT series), the second examination (just after MECT series) and the third and forth (follow-up) examination (3 and 6 months after MECT series). Blood, urine and feces samples and the evaluation of clinical effect and side-effects to MECT are performed at the same time points.
The primary outcome for the treatment phase is the treatment remission rate and response rate. The secondary outcomes included: symptom scale, Quality of life, Sleep therapy, Symptoms of anxiety, Rumination and safety assessment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Modified electroconvulsive therapy group
The adolescent MDD receiving modified electroconvulsive therapy and conventional medication.
干预措施: Modified Electroconvulsive Therapy (Device)
Modified electroconvulsive therapy group
The adolescent MDD receiving modified electroconvulsive therapy and conventional medication.
干预措施: Conventional pharmacotherapy (Drug)
Non-modified electroconvulsive therapy group
The adolescent MDD receiving only conventional medication.
干预措施: Conventional pharmacotherapy (Drug)
结局指标
主要结局
Changes in CDRS-R (Children's Depression Rating Scale, Revised) scores
时间窗: The treatment period was baseline, 2-4 weeks. The follow-up period was 1 month, 3 months, 6 months.
Clinical response (≥ 50% reduction in CDRS-R scores from baseline).
次要结局
- Changes in BDI (Beck's Depression Inventory) scores(The treatment period was baseline, 2-4 weeks. The follow-up period was 1 month, 3 months, 6 months.)
- Changes in suicide risk on C-SSRS (Columbia Suicide Severity Rating Scale) scores(Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months)
- Changes in SCARED (Screen for Child Anxiety Related Disorders) scores(Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months)
- Changes in PSQI (Pittsburgh Sleep Quality Index) scores(Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months)
- Changes in functional MRI(Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months)
- Changes in CGI-S (Clinical Global Impressions-Severity Scales) scores(Baseline of treatment period, 2-4 weeks)
- Changes in CGI-I (Clinical Global Impressions-Improvement Scales) scores(The treatment period was 2-4 weeks)
- Changes in AE（Adverse Event）Scale(The treatment period was 2-4 weeks; The follow-up period was 1 month, 3 months, 6 months.)
- Changes in Cerebral Blood Flow(Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months)
- Changes in PedsQL4.0 (The Pediatric Quality of Life Inventory 4.0) scores(Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months)
- Changes in RSS (Ruminative Responses Scale) scores(Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months)
- Assessment of OB/VQ（Olweus Bully/Victim Questionnaire）(Baseline of treatment period)
- Assessment of SAE（Serious Adverse Event）Scale(The treatment period was 2-4 weeks; The follow-up period was 1 month, 3 months, 6 months.)
- Changes in THINC-it(Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months)
- Changes in structural MRI T1 and T2(Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months)
- Changes in concentration of Glu and GABA in ACC(Baseline of treatment period, 2-4 weeks; The follow-up period was 3 months, 6 months)
- Assessment of CTQ（Childhood Trauma Questionnaire）(Baseline of treatment period)
研究者
Xinyu Zhou
Professor
First Affiliated Hospital of Chongqing Medical University