Pharmacotherapy and Psychotherapy for MDD After Remission on Psychology and Neuroimaging
- Conditions
- Depressive Disorder
- Interventions
- Drug: medicineBehavioral: medicine combined CBT
- Registration Number
- NCT01831440
- Lead Sponsor
- Nanjing Medical University
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Clinical diagnosis of major depressive disorder (MDD)
- Hamilton Rating Scale for Depression(HAMD) less than 7
- Bipolar disorder
- Substance dependence
- Neurological disorder or other mental disorder
- Severe body disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description medicine (SSRI antidepressants) medicine clinical routine antidepressant treatment--Selective serotonin reuptake inhibitors（SSRIs）. medicine combined CBT medicine combined CBT Besides clinical routine antidepressant treatment,participants receive CBT weekly for 8 weeks and monthly until the end of the study.
- Primary Outcome Measures
Name Time Method Hamilton Rating Scale for Depression (HAMD） 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.
- Secondary Outcome Measures
Name Time Method Magnetic Resonance Imaging one year Scanning sequency：3D、resting-state、task-state、Diffusion Tensor Imaging（DTI） Task:explicit and implicit emotional processes.
The Beck Depression Inventory (BDI) one year The Beck Depression Inventory (BDI), created by Dr. Aaron T. Beck, is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression.
Generic Quality of Life Inventory-74 one year Generic Quality of Life Inventory-74(GQOLI-74)created by Dr.Yang Desen and Dr. Li Lingjiang in 1998. It will be used for measuring the quality of life,efficacy and side effect.
Trial Locations
- Locations (1)
Nanjing Brain Hospital
🇨🇳Nanjing, Jiangsu, China