Pharmacotherapy and Psychotherapy for MDD After Remission on Psychology and Neuroimaging
Primary Purpose
Depressive Disorder
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
medicine combined CBT
medicine
Sponsored by
About this trial
This is an interventional prevention trial for Depressive Disorder focused on measuring depression, remission, Pharmacotherapy, psychotherapy, neuroimaging, psychology
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
Sites / Locations
- Nanjing Brain HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
medicine combined CBT
medicine (SSRI antidepressants)
Arm Description
Besides clinical routine antidepressant treatment,participants receive CBT weekly for 8 weeks and monthly until the end of the study.
clinical routine antidepressant treatment--Selective serotonin reuptake inhibitors(SSRIs).
Outcomes
Primary Outcome Measures
Hamilton Rating Scale for Depression (HAMD)
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 Outcome Measures
Magnetic Resonance Imaging
Scanning sequency:3D、resting-state、task-state、Diffusion Tensor Imaging(DTI) Task:explicit and implicit emotional processes.
The Beck Depression Inventory (BDI)
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
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.
Full Information
NCT ID
NCT01831440
First Posted
March 28, 2013
Last Updated
April 12, 2013
Sponsor
Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01831440
Brief Title
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
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder
Keywords
depression, remission, Pharmacotherapy, psychotherapy, neuroimaging, psychology
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
medicine combined CBT
Arm Type
Other
Arm Description
Besides clinical routine antidepressant treatment,participants receive CBT weekly for 8 weeks and monthly until the end of the study.
Arm Title
medicine (SSRI antidepressants)
Arm Type
Other
Arm Description
clinical routine antidepressant treatment--Selective serotonin reuptake inhibitors(SSRIs).
Intervention Type
Behavioral
Intervention Name(s)
medicine combined CBT
Other Intervention Name(s)
antidepressant combined cognitive-behavioral therapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
medicine
Other Intervention Name(s)
SSRI antidepressants
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression (HAMD)
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Magnetic Resonance Imaging
Description
Scanning sequency:3D、resting-state、task-state、Diffusion Tensor Imaging(DTI) Task:explicit and implicit emotional processes.
Time Frame
one year
Title
The Beck Depression Inventory (BDI)
Description
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.
Time Frame
one year
Title
Generic Quality of Life Inventory-74
Description
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.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ma Hui
Phone
025-82296357
Email
mahui_njmu@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhang Ning
Organizational Affiliation
Nanjing Brain Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing Brain Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ma Hui
Phone
025-82296357
Email
mahui_njmu@126.com
First Name & Middle Initial & Last Name & Degree
Zhang Ning
12. IPD Sharing Statement
Citations:
PubMed Identifier
17306047
Citation
Mattisson C, Bogren M, Horstmann V, Munk-Jorgensen P, Nettelbladt P. The long-term course of depressive disorders in the Lundby Study. Psychol Med. 2007 Jun;37(6):883-91. doi: 10.1017/S0033291707000074. Epub 2007 Feb 19.
Results Reference
background
PubMed Identifier
15947516
Citation
Kuehner C. An evaluation of the 'Coping with Depression Course' for relapse prevention with unipolar depressed patients. Psychother Psychosom. 2005;74(4):254-9. doi: 10.1159/000085150.
Results Reference
background
PubMed Identifier
12884889
Citation
Paykel ES, Scott J, Teasdale JD, Johnson AL, Garland A, Moore R, Jenaway A, Cornwall PL, Hayhurst H, Abbott R, Pope M. Prevention of relapse in residual depression by cognitive therapy: a controlled trial. Arch Gen Psychiatry. 1999 Sep;56(9):829-35. doi: 10.1001/archpsyc.56.9.829.
Results Reference
background
PubMed Identifier
17367751
Citation
Watkins E, Scott J, Wingrove J, Rimes K, Bathurst N, Steiner H, Kennell-Webb S, Moulds M, Malliaris Y. Rumination-focused cognitive behaviour therapy for residual depression: a case series. Behav Res Ther. 2007 Sep;45(9):2144-54. doi: 10.1016/j.brat.2006.09.018. Epub 2007 Mar 26.
Results Reference
background
PubMed Identifier
16644768
Citation
Petersen TJ. Enhancing the efficacy of antidepressants with psychotherapy. J Psychopharmacol. 2006 May;20(3 Suppl):19-28. doi: 10.1177/1359786806064314.
Results Reference
background
PubMed Identifier
19374457
Citation
Vitiello B. Combined cognitive-behavioural therapy and pharmacotherapy for adolescent depression: Does it improve outcomes compared with monotherapy? CNS Drugs. 2009;23(4):271-80. doi: 10.2165/00023210-200923040-00001.
Results Reference
background
PubMed Identifier
11059998
Citation
Scott J, Teasdale JD, Paykel ES, Johnson AL, Abbott R, Hayhurst H, Moore R, Garland A. Effects of cognitive therapy on psychological symptoms and social functioning in residual depression. Br J Psychiatry. 2000 Nov;177:440-6. doi: 10.1192/bjp.177.5.440.
Results Reference
background
Links:
URL
http://www.cbtchina.com.cn/
Description
Click here for more information about Chinese Cognitive-Behavioral Therapy(CCBT)
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Pharmacotherapy and Psychotherapy for MDD After Remission on Psychology and Neuroimaging
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