Pharmacotherapy and Psychotherapy for MDD After Remission on Psychology and Neuroimaging

Nanjing Medical University

Status: Unknown

Conditions: Depressive Disorder

Treatments: Drug: medicine; Behavioral: medicine combined CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT01831440

ZKX10022

Details and patient eligibility

About

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.

Full 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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

medicine combined CBT

Other group

Description:

Besides clinical routine antidepressant treatment,participants receive CBT weekly for 8 weeks and monthly until the end of the study.

Treatment:

Behavioral: medicine combined CBT

medicine (SSRI antidepressants)

Other group

Description:

clinical routine antidepressant treatment--Selective serotonin reuptake inhibitors（SSRIs）.

Treatment:

Drug: medicine