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Repetitive Transcranial Magnetic Stimulation(rTMS) in the Treatment of Depression

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ClinicalTrials.gov Identifier: NCT01198561
Recruitment Status : Unknown
Verified December 2015 by Doh Kwan Kim, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : September 10, 2010
Last Update Posted : December 31, 2015
Sponsor:
Information provided by (Responsible Party):
Doh Kwan Kim, Samsung Medical Center

Brief Summary:
The objective of this study is to investigate the antidepressant efficacy of rTMS, and to assess cortical metabolism before and after rTMS sessions in patients with major depression. We also aimed to investigate differences between the responders and nonresponders to rTMS and what would predict clinical response to rTMS.

Condition or disease Intervention/treatment
Major Depressive Disorder Device: repetitive Transcranial Magnetic Stimulation

Detailed Description:
The specific aims of this study is to: (1) evaluate the antidepressant efficacy of rTMS on major depression; (2) evaluate the effects of rTMS on cognitive function in depressive patients; (3) assess the effects of rTMS on cerebral glucose metabolism in depressive patients as measured by 18FDG PET; (4) investigate the differences of the regional cerebral glucose uptake changes during rTMS between responders and nonresponders to rTMS.

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Repetitive Transcranial Magnetic Stimulation(rTMS) in the Treatment of Depression : Effect of TMS on Depression, Cognitive Function, and Regional Cerebral Glucose Metabolism
Study Start Date : February 2006
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
repetitive Transcranial Magnetic Stimulation
repetitive Transcranial Magnetic Stimulation is a depressive patient group treated with rTMS
Device: repetitive Transcranial Magnetic Stimulation
10 times repetitive TMS, high frequency



Primary Outcome Measures :
  1. Hamilton depression rating scale (HAM-D 17) [ Time Frame: baseline, 1, 2, and 4 weeks after TMS ]
    measuring instrument of severity of depressive symptoms


Biospecimen Retention:   Samples With DNA
serum, plasma and DNAs


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with major depressive disorder, who were not responsive to antidepressants
Criteria

Inclusion Criteria:

  • Twenty patients fulfilling the diagnostic criteria of major depression according to DSM IV will be enrolled in the study.
  • Antidepressant medication will be maintained throughout the study period.

Exclusion Criteria:

  • Exclusion criteria are current neurological or other psychiatric disorders, as well as a history of epileptic seizures, substantial brain damage or neurosurgical operation, according to established safety criteria.
  • To exclude the effect of drug changes on post-rTMS cerebral glucose metabolism, the combinations and dosage of pre-rTMS antidepressant drugs will remain unchanged until the post-rTMS 18FDG PET is done.

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): NCT01198561


Contacts
Contact: Doh Kwan Kim, M.D., Ph.D. 82-2-3410-3582 paulkim@skku.edu

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Kangnam-Ku, Korea, Republic of, 135-710
Contact: Doh Kwan Kim, M.D., Ph.D.    82-2-3410-3582    paulkim@skku.edu   
Principal Investigator: Doh Kwan Kim, M.D., Ph.D.         
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Doh K KIm, Ph.D Samsung Medical Center

Responsible Party: Doh Kwan Kim, M.D., Ph.D. / Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01198561     History of Changes
Other Study ID Numbers: 2005-08-072
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: December 31, 2015
Last Verified: December 2015

Keywords provided by Doh Kwan Kim, Samsung Medical Center:
repetitive Transcranial Magnetic Stimulation
Major Depressive Disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders