Suspended

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

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What is being tested

medicine combined CBT

+ medicine

BehavioralDrug
Who is being recruted

Behavior+3

+ Mental Disorders

+ Behavioral Symptoms

From 18 to 55 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: January 2011
See protocol details

Summary

Principal SponsorNanjing Medical University
Study ContactMa HuiMore contacts
Last updated: April 15, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2011

Actual date on which the first participant was enrolled.

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).

Principal SponsorNanjing Medical University
Study ContactMa HuiMore contacts
Last updated: April 15, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMental DisordersBehavioral SymptomsMood DisordersDepressionDepressive Disorder

Criteria

2 inclusion criteria required to participate
Clinical diagnosis of major depressive disorder (MDD)

Hamilton Rating Scale for Depression(HAMD) less than 7

4 exclusion criteria prevent from participating
Bipolar disorder

Neurological disorder or other mental disorder

Severe body disease

Substance dependence

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Nanjing Brain Hospital

Nanjing, ChinaOpen Nanjing Brain Hospital in Google Maps
SuspendedOne Study Center