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

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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

Study Description
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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.

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Magnetic Resonance Imaging Study of Cognitive-Behavior Therapy for Major Depressive Disorder
Study Start Date : December 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Magnetic Resonance Imaging [ Time Frame: an expected average of 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460212


Contacts
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Contact: Chun Wang, doctor 86 15850566376 fm51109@163.com

Locations
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China, Jiangsu
Nanjing Brain Hospital Recruiting
Nanjing, Jiangsu, China, 210029
Principal Investigator: Chun Wang         
Sponsors and Collaborators
Nanjing Medical University
Investigators
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Principal Investigator: Chun Wang, doctor Nanjing Medical University
More Information
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Responsible Party: Chun Wang, The attending physician, Dr., Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01460212    
Other Study ID Numbers: QYK09184
First Posted: October 26, 2011    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014
Keywords provided by Chun Wang, Nanjing Medical University:
Cognitive-Behavior Therapy
Magnetic Resonance Imaging
major depressive disorder
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Fluvoxamine
Citalopram
Fluoxetine
Paroxetine
Sertraline
Antidepressive Agents
Serotonin Uptake Inhibitors
 Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Cytochrome P-450 CYP1A2 Inhibitors