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临床试验/NCT01831440
NCT01831440Unknown不适用

The Influence of Pharmacotherapy and Psychotherapy for MDD After Remission on Psychology and Neuroimaging:A Comparative Longitudinal Study

Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物

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

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

Other

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)

Other

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

发起方
Nanjing Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ning Zhang

Vice-President of Nanjing Brain Hospital

Nanjing Medical University

研究点 (1)

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