Pharmacotherapy and Psychotherapy for MDD After Remission on Psychology and Neuroimaging
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|ClinicalTrials.gov Identifier: NCT01831440|
Recruitment Status : Unknown
Verified April 2013 by Ning Zhang, Nanjing Medical University.
Recruitment status was: Recruiting
First Posted : April 15, 2013
Last Update Posted : April 15, 2013
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.
|Condition or disease||Intervention/treatment|
|Depressive Disorder||Behavioral: medicine combined CBT Drug: medicine|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Influence of Pharmacotherapy and Psychotherapy for MDD After Remission on Psychology and Neuroimaging：A Comparative Longitudinal Study|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||December 2014|
medicine combined CBT
Besides clinical routine antidepressant treatment,participants receive CBT weekly for 8 weeks and monthly until the end of the study.
Behavioral: medicine combined CBT
medicine：Clinical routine antidepressant treatment CBT：During the treatment period，weekly for 8 weeks，and monthly for the maintenance phase.Therapists receive group supervision monthly.
Other Name: antidepressant combined cognitive-behavioral therapy
medicine (SSRI antidepressants)
clinical routine antidepressant treatment——Selective serotonin reuptake inhibitors（SSRIs）.
Participants receive only clinical routine antidepressant treatment,Which include fluoxetine (Prozac); sertraline (Zoloft); paroxetine (Paxil); citalopram (Celexa) ;escitalopram (Lexapro) and fluvoxamine (Luvox). It will be chosen according to special condition of every patient.
Other Name: SSRI antidepressants
- 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.
- Magnetic Resonance Imaging [ Time Frame: one year ]Scanning sequency：3D、resting-state、task-state、Diffusion Tensor Imaging（DTI） Task:explicit and implicit emotional processes.
- The Beck Depression Inventory (BDI) [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01831440
|Contact: Ma Huiemail@example.com|
|Nanjing Brain Hospital||Recruiting|
|Nanjing, Jiangsu, China, 210029|
|Contact: Ma Hui 025-82296357 firstname.lastname@example.org|
|Principal Investigator: Zhang Ning|
|Principal Investigator:||Zhang Ning||Nanjing Brain Hospital|