Pharmacotherapy and Psychotherapy for MDD After Remission on Psychology and Neuroimaging

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Nanjing Medical University
Sponsor:
Information provided by (Responsible Party):
Ning Zhang, Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01831440
First received: March 28, 2013
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Depressive Disorder
Behavioral: medicine combined CBT
Drug: medicine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Influence of Pharmacotherapy and Psychotherapy for MDD After Remission on Psychology and Neuroimaging:A Comparative Longitudinal Study

Resource links provided by NLM:


Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Hamilton Rating Scale for Depression (HAMD) [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Scanning sequency:3D、resting-state、task-state、Diffusion Tensor Imaging(DTI) Task:explicit and implicit emotional processes.

  • The Beck Depression Inventory (BDI) [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
medicine combined CBT
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:Clinical routine antidepressant treatment CBT:During the treatment period,weekly for 8 weeks,and monthly for the maintenance phase.Therapists receive group supervision monthly.
Other Name: antidepressant combined cognitive-behavioral therapy
medicine (SSRI antidepressants)
clinical routine antidepressant treatment——Selective serotonin reuptake inhibitors(SSRIs).
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.
Other Name: SSRI antidepressants

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).

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01831440

Contacts
Contact: Ma Hui 025-82296357 mahui_njmu@126.com

Locations
China, Jiangsu
Nanjing Brain Hospital Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Ma Hui    025-82296357    mahui_njmu@126.com   
Principal Investigator: Zhang Ning         
Sponsors and Collaborators
Nanjing Medical University
Investigators
Principal Investigator: Zhang Ning Nanjing Brain Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Ning Zhang, Vice-President of Nanjing Brain Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01831440     History of Changes
Other Study ID Numbers: ZKX10022
Study First Received: March 28, 2013
Last Updated: April 12, 2013
Health Authority: China: Ministry of Health

Keywords provided by Nanjing Medical University:
depression
remission
Pharmacotherapy
psychotherapy
neuroimaging
psychology

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Antidepressive Agents
Central Nervous System Agents
Pharmacologic Actions
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014