Clinical trial NCT01831440: Pharmacotherapy and Psychotherapy for MDD After Remission on Psychology and Neuroimaging
Official title: The Influence of Pharmacotherapy and Psychotherapy for MDD After Remission on Psychology and Neuroimaging：A Comparative Longitudinal Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Disorder
Keywords: depression
remission
Pharmacotherapy
psychotherapy
neuroimaging
psychology
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2013-04-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of major depressive disorder (MDD)
* Hamilton Rating Scale for Depression(HAMD) less than 7

Exclusion Criteria:

* Bipolar disorder
* Substance dependence
* Neurological disorder or other mental disorder
* Severe body disease

Primary outcomes:
measure: Hamilton Rating Scale for Depression (HAMD）
timeFrame: one year
Secondary outcomes:
measure: Magnetic Resonance Imaging
timeFrame: one year
measure: The Beck Depression Inventory (BDI)
timeFrame: one year
measure: Generic Quality of Life Inventory-74
timeFrame: one year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Brain Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Brain Hospital
name: Zhang Ning
role: PRINCIPAL_INVESTIGATOR
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