NCT01831440

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 15, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 15, 2013

Status Verified

April 1, 2013

Enrollment Period

3 years

First QC Date

March 28, 2013

Last Update Submit

April 12, 2013

Conditions

Depressive Disorder

Keywords

depressionremissionPharmacotherapypsychotherapyneuroimagingpsychology

Outcome Measures

Primary Outcomes (1)

  • 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.

    one year

Secondary Outcomes (3)

  • Magnetic Resonance Imaging

    one year

  • The Beck Depression Inventory (BDI)

    one year

  • Generic Quality of Life Inventory-74

    one year

Study Arms (2)

medicine combined CBT

OTHER

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 (SSRI antidepressants)

OTHER

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

Drug: medicine

Interventions

medicine combined CBTBEHAVIORAL

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.

Also known as: antidepressant combined cognitive-behavioral therapy
medicine combined CBT
medicineDRUG

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.

Also known as: SSRI antidepressants
medicine (SSRI antidepressants)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of major depressive disorder (MDD)
  • Hamilton Rating Scale for Depression(HAMD) less than 7

You may not qualify if:

  • Bipolar disorder
  • Substance dependence
  • Neurological disorder or other mental disorder
  • Severe body disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Brain Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (8)

  • 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.

    PMID: 17306047BACKGROUND

  • 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.

    PMID: 15947516BACKGROUND

  • 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.

    PMID: 12884889BACKGROUND

  • 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.

    PMID: 17367751BACKGROUND

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

    PMID: 16644768BACKGROUND

  • 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.

    PMID: 19374457BACKGROUND

  • 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.

    PMID: 11059998BACKGROUND

  • 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.

    PMID: 37641013DERIVED

Related Links

MeSH Terms

Conditions

Depressive DisorderDepression

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Officials

  • Zhang Ning

    Nanjing Brain Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ma Hui

CONTACT

025-82296357mahui_njmu@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice-President of Nanjing Brain Hospital

Study Record Dates

First Submitted

March 28, 2013

First Posted

April 15, 2013

Study Start

January 1, 2011

Primary Completion

January 1, 2014

Study Completion

December 1, 2014

Last Updated

April 15, 2013

Record last verified: 2013-04

Locations

CN(1)