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Magnetic Resonance Imaging Study of Attributional Retraining for Major Depressive Disorder

This study is not yet open for participant recruitment.
Verified October 2011 by Nanjing Medical University
Sponsor:
Information provided by (Responsible Party):
Chun Wang, Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01460212
First received: October 24, 2011
Last updated: October 25, 2011
Last verified: October 2011
History of Changes
  Purpose

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 arrtibutional retraining 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: attributional retraining
 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 Attributional Retraining for Major Depressive Disorder

Resource links provided by NLM:

U.S. FDA Resources

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: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: attributional retraining group
treatment with attributional retraining
 Behavioral: attributional retraining
one of cognitive behavioural therapies
Other Name: attributional therapy (cognitive behavioural therapy)
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 acorrding to special condition of every patient.
Other Names:
  • fluoxetine (Prozac)
  • sertraline (Zoloft)
  • paroxetine (Paxil)
  • citalopram (Celexa)
  • escitalopram (Lexapro)
  • fluvoxamine (Luvox)

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01460212

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

Locations
China, Jiangsu
Nanjing Brain Hospital Not yet recruiting
Nanjing, Jiangsu, China, 210029
Sponsors and Collaborators
Nanjing Medical University
Investigators
Principal Investigator: Chun Wang, doctor Nanjing Medical University
  More Information

No publications provided

Responsible Party: Chun Wang, The attending physician, Dr., Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01460212     History of Changes
Other Study ID Numbers: QYK09184
Study First Received: October 24, 2011
Last Updated: October 25, 2011
Health Authority: China: Ethics Committee

Keywords provided by Nanjing Medical University:
attributional retraining
Magnetic Resonance Imaging
major depressive disorder

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Citalopram
Fluoxetine
Paroxetine
Sertraline
Fluvoxamine
Serotonin Uptake Inhibitors
Dexetimide
Psychotropic Drugs
 Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antidepressive Agents, Second-Generation
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists

ClinicalTrials.gov processed this record on June 18, 2013