Skip to main content
Clinical Trials/NCT01831440
NCT01831440
Unknown
N/A

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

Nanjing Medical University1 site in 1 country200 target enrollmentJanuary 2011

Overview

Phase
N/A
Intervention
medicine combined CBT
Conditions
Depressive Disorder
Sponsor
Nanjing Medical University
Enrollment
200
Locations
1
Primary Endpoint
Hamilton Rating Scale for Depression (HAMD)
Last Updated
13 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
December 2014
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Nanjing Medical University
Responsible Party
Principal Investigator
Principal Investigator

Ning Zhang

Vice-President of Nanjing Brain Hospital

Nanjing Medical University

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

Arms & Interventions

medicine combined CBT

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

Intervention: medicine combined CBT

medicine (SSRI antidepressants)

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

Intervention: medicine

Outcomes

Primary Outcomes

Hamilton Rating Scale for Depression (HAMD)

Time Frame: 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 Outcomes

  • Magnetic Resonance Imaging(one year)
  • The Beck Depression Inventory (BDI)(one year)
  • Generic Quality of Life Inventory-74(one year)

Study Sites (1)

Loading locations...

Similar Trials