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Depressive DisorderNCT01831440

Pharmacotherapy and Psychotherapy for MDD After Remission on Psychology and Neuroimaging

A study testing medicine combined CBT and medicine in people with Depressive Disorder, run by Nanjing Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Depressive Disorder
What is being tested?
medicine combined CBT and medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
Jan 2011to Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Ma Hui contact

025-82296357

mahui_njmu@126.com

China1 site, 1 recruiting

  • Nanjing Brain Hospital

    Nanjing, Jiangsu, 210029

    Ma Hui, 025-82296357, mahui_njmu@126.com

    Zhang Ning

    Recruiting

Other trials in China

About this study

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

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.

Read the 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).

Being tested
medicine combined CBT, medicine
Keywords
depression, remission, Pharmacotherapy, psychotherapy, neuroimaging, psychology
Medical subject headings
Depressive Disorder, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • medicine combined CBTBehavioural

    Also called antidepressant combined cognitive-behavioral therapy

    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.

  • medicineDrug

    Also called SSRI antidepressants

    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.

Study groups in NCT01831440
Study groupRoleWhat they receive
medicine combined CBTOtherBesides clinical routine antidepressant treatment,participants receive CBT weekly for 8 weeks and monthly until the end of the study.
Receives: Behavioral: medicine combined CBT
medicine (SSRI antidepressants)Otherclinical routine antidepressant treatment--Selective serotonin reuptake inhibitors（SSRIs）.
Receives: Drug: medicine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: one year

Secondary outcomes (3)

  1. Magnetic Resonance Imaging

    Scanning sequency：3D、resting-state、task-state、Diffusion Tensor Imaging（DTI） Task:explicit and implicit emotional processes.

    Measured: one year

  2. 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.

    Measured: one year

  3. 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.

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2013 (estimated)
  2. Study startJan 2011
  3. Primary completionJan 2014 (estimated)
  4. Study completionDec 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01831440
Sponsor's protocol ID
ZKX10022
Status last verified
Apr 2013
First submitted
28 Mar 2013
Last updated
15 Apr 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17306047

  • 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.

    PubMed 15947516

  • 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.

    PubMed 12884889

  • 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.

    PubMed 17367751

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

    PubMed 16644768

  • 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.

    PubMed 19374457

  • 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.

    PubMed 11059998

  • 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.

    PubMed 37641013

Questions about this trial

What is this clinical trial studying?

A study testing medicine combined CBT and medicine in people with Depressive Disorder, run by Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ma Hui (025-82296357, mahui_njmu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hamilton Rating Scale for Depression (HAMD） (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01831440, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2013.

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