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

Primary Purpose

Major Depressive Disorder

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
SSRI antidepressants
Cognitive-Behavior Therapy
Sponsored by
Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Cognitive-Behavior Therapy, Magnetic Resonance Imaging, major depressive disorder

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Nanjing Brain HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive-Behavior Therapy group

SSRI antidepressants

Arm Description

treatment with Cognitive-Behavior Therapy

treatment by SSRI antidepressant

Outcomes

Primary Outcome Measures

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. Minimum and maximum possible values are respectively 0 and 78. Lower scores show more mild depression.

Secondary Outcome Measures

Magnetic Resonance Imaging

Full Information

First Posted
October 24, 2011
Last Updated
September 24, 2014
Sponsor
Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01460212
Brief Title
Magnetic Resonance Imaging Study of Cognitive-Behavior Therapy for Major Depressive Disorder
Official Title
Magnetic Resonance Imaging Study of Cognitive-Behavior Therapy for Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Cognitive-Behavior Therapy, Magnetic Resonance Imaging, major depressive disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive-Behavior Therapy group
Arm Type
Experimental
Arm Description
treatment with Cognitive-Behavior Therapy
Arm Title
SSRI antidepressants
Arm Type
Active Comparator
Arm Description
treatment by SSRI antidepressant
Intervention Type
Drug
Intervention Name(s)
SSRI antidepressants
Other Intervention Name(s)
fluoxetine (Prozac), sertraline (Zoloft), paroxetine (Paxil), citalopram (Celexa), escitalopram (Lexapro), fluvoxamine (Luvox)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavior Therapy
Other Intervention Name(s)
cognitive behavioural therapy（CBT）
Intervention Description
The essence of CBT is a learning process through which an appropriate pattern in cognitive and behavioral could be learn and stored as memory
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression (HAMD)
Description
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.
Time Frame
an expected average of 6 months
Secondary Outcome Measure Information:
Title
Magnetic Resonance Imaging
Time Frame
an expected average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chun Wang, doctor
Phone
86 15850566376
Email
fm51109@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun Wang, doctor
Organizational Affiliation
Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing Brain Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun Wang

12. IPD Sharing Statement

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

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