Magnetic Resonance Imaging Study of Cognitive-Behavior Therapy for Major Depressive Disorder
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 major-depressive-disorder
Started Dec 2011
Longer than P75 for phase_4 major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2011
CompletedFirst Posted
Study publicly available on registry
October 26, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedSeptember 25, 2014
September 1, 2014
3 years
October 24, 2011
September 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
an expected average of 6 months
Secondary Outcomes (1)
Magnetic Resonance Imaging
an expected average of 6 months
Study Arms (2)
Cognitive-Behavior Therapy group
EXPERIMENTALtreatment with Cognitive-Behavior Therapy
SSRI antidepressants
ACTIVE COMPARATORtreatment by SSRI antidepressant
Interventions
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.
The essence of CBT is a learning process through which an appropriate pattern in cognitive and behavioral could be learn and stored as memory
Eligibility Criteria
You may qualify if:
- meet SCID -Ⅰ/P major depressive disorder diagnosis;
- Right handedness;
- good visual acuity.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanjing Brain Hospital
Nanjing, Jiangsu, 210029, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chun Wang, doctor
Nanjing Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- The attending physician, Dr.
Study Record Dates
First Submitted
October 24, 2011
First Posted
October 26, 2011
Study Start
December 1, 2011
Primary Completion
December 1, 2014
Study Completion
October 1, 2015
Last Updated
September 25, 2014
Record last verified: 2014-09