Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01460212
Recruitment Status : Unknown
Verified September 2014 by Chun Wang, Nanjing Medical University.
Recruitment status was:  Recruiting
First Posted : October 26, 2011
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):
Chun Wang, Nanjing Medical University

Tracking Information
First Submitted Date  ICMJE October 24, 2011
First Posted Date  ICMJE October 26, 2011
Last Update Posted Date September 25, 2014
Study Start Date  ICMJE December 2011
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2011)
Hamilton Rating Scale for Depression (HAMD) [ Time Frame: an expected average of 6 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01460212 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2011)
Magnetic Resonance Imaging [ Time Frame: an expected average of 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Magnetic Resonance Imaging Study of Cognitive-Behavior Therapy for Major Depressive Disorder
Official Title  ICMJE Magnetic Resonance Imaging Study of Cognitive-Behavior Therapy for Major Depressive Disorder
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • 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)
  • 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)
Study Arms  ICMJE
  • Experimental: Cognitive-Behavior Therapy group
    treatment with Cognitive-Behavior Therapy
    Intervention: Behavioral: Cognitive-Behavior Therapy
  • Active Comparator: SSRI antidepressants
    treatment by SSRI antidepressant
    Intervention: Drug: SSRI antidepressants
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 25, 2011)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2015
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01460212
Other Study ID Numbers  ICMJE QYK09184
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chun Wang, Nanjing Medical University
Study Sponsor  ICMJE Nanjing Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chun Wang, doctor Nanjing Medical University
PRS Account Nanjing Medical University
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP