Magnetic Resonance Imaging Study of Cognitive-Behavior Therapy for Major Depressive Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Nanjing Medical University
Information provided by (Responsible Party):
Chun Wang, Nanjing Medical University Identifier:
First received: October 24, 2011
Last updated: September 24, 2014
Last verified: September 2014
Study hypothesis: psychotherapy and SSRI treatment effect in different brain way: psychotherapy in "up to down" way and SSRI in "down to up" way. The investigators will explore this hypothesis in major depressive disorder outpatients with Magnetic Resonance Imaging analysis in this study. Patients in different groups will be treated by psychotherapy or SSRI treatment. They will all be checked with Magnetic Resonance Imaging pro and after 12 weeks of treatment.

Condition Intervention Phase
Major Depressive Disorder
Drug: SSRI antidepressants
Behavioral: Cognitive-Behavior Therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Magnetic Resonance Imaging Study of Cognitive-Behavior Therapy for Major Depressive Disorder

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: an expected average of 6 months ] [ 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. Minimum and maximum possible values are respectively 0 and 78. Lower scores show more mild depression.

Secondary Outcome Measures:
  • Magnetic Resonance Imaging [ Time Frame: an expected average of 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: December 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive-Behavior Therapy group
treatment with Cognitive-Behavior Therapy
Behavioral: Cognitive-Behavior Therapy
The essence of CBT is a learning process through which an appropriate pattern in cognitive and behavioral could be learn and stored as memory
Other Name: cognitive behavioural therapy(CBT)
Active Comparator: SSRI antidepressants
treatment by SSRI antidepressant
Drug: SSRI antidepressants
SSRI antidepressants are Selective serotonin reuptake inhibitors. They 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 Names:
  • fluoxetine (Prozac)
  • sertraline (Zoloft)
  • paroxetine (Paxil)
  • citalopram (Celexa)
  • escitalopram (Lexapro)
  • fluvoxamine (Luvox)

Detailed Description:
Patients meeting the inclusion criteria undergo an examination that included a diagnostic interview, vision test, and psychophysiological measures. Participants then undergo the baseline fMRI scan within 48 hours, after that, they will receive psychotherapy or SSRI treatment.and returned the scan once they completed the therapy.

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • meet SCID -Ⅰ/P major depressive disorder diagnosis;
  • Right handedness;
  • good visual acuity.

Exclusion Criteria:

  • neurological disease ;
  • serious physical illness (e.g. heart, lung, liver, kidney or blood system disease);
  • with other mental disorder;
  • psychotic symptoms
  • personality disorders;
  • pregnancy;
  • suicidal risk;
  • treatment by antidepressants or other psychotropic medications within 6 months prior to the start of the trial;
  • with contraindication for MRI
  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 identifier: NCT01460212

Contact: Chun Wang, doctor 86 15850566376

China, Jiangsu
Nanjing Brain Hospital Recruiting
Nanjing, Jiangsu, China, 210029
Principal Investigator: Chun Wang         
Sponsors and Collaborators
Nanjing Medical University
Principal Investigator: Chun Wang, doctor Nanjing Medical University
  More Information

Responsible Party: Chun Wang, The attending physician, Dr., Nanjing Medical University Identifier: NCT01460212     History of Changes
Other Study ID Numbers: QYK09184 
Study First Received: October 24, 2011
Last Updated: September 24, 2014
Health Authority: China: Ethics Committee

Keywords provided by Nanjing Medical University:
Cognitive-Behavior Therapy
Magnetic Resonance Imaging
major depressive disorder

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Antidepressive Agents
Psychotropic Drugs processed this record on May 26, 2016