Pharmacotherapy and Psychotherapy for MDD After Remission on Psychology and Neuroimaging

Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01831440
• Other study ID #: ZKX10022
• Status: Recruiting
• Phase: N/A
• First received: March 28, 2013
• Last updated: April 12, 2013
• Start date: January 2011
• Est. completion date: December 2014

Study information

• Verified date: April 2013
• Source: Nanjing Medical University
• Contact: Ma Hui
• Phone: 025-82296357
• Email: mahui_njmu[@]126.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical 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.

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Drug:
• 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.

Locations

Country	Name	City	State
China	Nanjing Brain Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (7)

Kuehner C. An evaluation of the 'Coping with Depression Course' for relapse prevention with unipolar depressed patients. Psychother Psychosom. 2005;74(4):254-9. — View Citation

Mattisson C, Bogren M, Horstmann V, Munk-Jörgensen P, Nettelbladt P. The long-term course of depressive disorders in the Lundby Study. Psychol Med. 2007 Jun;37(6):883-91. Epub 2007 Feb 19. — View 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. — View Citation

Petersen TJ. Enhancing the efficacy of antidepressants with psychotherapy. J Psychopharmacol. 2006 May;20(3 Suppl):19-28. Review. — View 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. — View 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. — View 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. Epub 2007 Mar 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Magnetic Resonance Imaging	Scanning sequency:3D?resting-state?task-state?Diffusion Tensor Imaging(DTI) Task:explicit and implicit emotional processes.	one year	Yes
Secondary	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.	one year	Yes
Secondary	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.	one year	Yes

External Links

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