Pharmacotherapy and Psychotherapy for MDD After Remission on Psychology and Neuroimaging

NCT ID: NCT01831440

Last Updated: 2013-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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).

Conditions

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Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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medicine combined CBT

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

Group Type OTHER

medicine combined CBT

Intervention Type BEHAVIORAL

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.

medicine (SSRI antidepressants)

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

Group Type OTHER

medicine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type BEHAVIORAL

medicine

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.

Intervention Type DRUG

Other Intervention Names

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antidepressant combined cognitive-behavioral therapy SSRI antidepressants

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ning Zhang

Vice-President of Nanjing Brain Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhang Ning

Role: PRINCIPAL_INVESTIGATOR

Nanjing Brain Hospital

Locations

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Nanjing Brain Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ma Hui

Role: CONTACT

025-82296357

Facility Contacts

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Ma Hui

Role: primary

025-82296357

References

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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.

Reference Type BACKGROUND
PMID: 17306047 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15947516 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12884889 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17367751 (View on PubMed)

Petersen TJ. Enhancing the efficacy of antidepressants with psychotherapy. J Psychopharmacol. 2006 May;20(3 Suppl):19-28. doi: 10.1177/1359786806064314.

Reference Type BACKGROUND
PMID: 16644768 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19374457 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11059998 (View on PubMed)

Zhong J, Xu J, Wang Z, Yang H, Li J, Yu H, Huang W, Wan C, Ma H, Zhang N. Changes in brain functional networks in remitted major depressive disorder: a six-month follow-up study. BMC Psychiatry. 2023 Aug 28;23(1):628. doi: 10.1186/s12888-023-05082-3.

Reference Type DERIVED
PMID: 37641013 (View on PubMed)

Related Links

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http://www.cbtchina.com.cn/

Click here for more information about Chinese Cognitive-Behavioral Therapy(CCBT)

Other Identifiers

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ZKX10022

Identifier Type: -

Identifier Source: org_study_id

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