The Influence of Pharmacotherapy and Psychotherapy for MDD After Remission on Psychology and Neuroimaging:A Comparative Longitudinal Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Hamilton Rating Scale for Depression (HAMD)
研究概览
简要总结
The purpose of this study is to determine the level of residual symptoms and psychosocial factors affecting recovery of psychosocial functions in MDD patients who reach remission, and investigate the recovery process of psychosocial functions.
The investigators suppose that even the patient is well-treated by drug,there are still many residual symptoms,and they also exist different degree of damage in the structure and functions of brain. CBT could help them obtain better recovery,especially in psychosocial functions.
详细描述
Objective
At present, clinical remission of depression is defined as a final HAMD score of less than 7. However, in clinical practice, the psychosocial functions of patients who reach remission are far from complete recovery. The recovery of psychosocial functions lags behind the disappearance of symptoms.so,we aim to determine the level of residual symptoms and psychosocial factors affecting recovery of psychosocial functions in MDD patients who reach remission, and investigate the recovery process of psychosocial functions.
Method:200 MDD patients who met the inclusion criteria were randomly divided into CBT group and control group.All of subjects would complete the psychological assessment at 0,1st,2nd,6th and 12th months for CBT group and 0,2nd,12th months for control group.ALL participants would undergo magnetic resonance imaging at 0,2nd,12th months.The scanning sequence is 3D,resting-state,task-state and diffusion tensor imaging(DTI).During the magnetic resonance imaging(MRI) scans, subjects performed the facial and gender recognition tasks with three different facial stimuli(positive/neutral/negative).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of major depressive disorder (MDD)
- •Hamilton Rating Scale for Depression(HAMD) less than 7
排除标准
- •Bipolar disorder
- •Substance dependence
- •Neurological disorder or other mental disorder
- •Severe body disease
研究组 & 干预措施
medicine combined CBT
Besides clinical routine antidepressant treatment,participants receive CBT weekly for 8 weeks and monthly until the end of the study.
干预措施: medicine combined CBT (Behavioral)
medicine (SSRI antidepressants)
clinical routine antidepressant treatment--Selective serotonin reuptake inhibitors(SSRIs).
干预措施: medicine (Drug)
结局指标
主要结局
Hamilton Rating Scale for Depression (HAMD)
时间窗: one year
The 24-item version of the Hamilton Rating Scale for Depression (HAMD; Hamilton, 1960) will be used for measuring severity of depressive symptoms.remission of depression is defined as a final HAMD score of less than 7.
次要结局
- Magnetic Resonance Imaging(one year)
- The Beck Depression Inventory (BDI)(one year)
- Generic Quality of Life Inventory-74(one year)
研究者
Ning Zhang
Vice-President of Nanjing Brain Hospital
Nanjing Medical University
