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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Doh Kwan Kim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01198561
First received: September 8, 2010
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

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 Intervention
Major Depressive Disorder
Device: repetitive Transcranial Magnetic Stimulation

Study Type: Observational
Study Design: 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

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Hamilton depression rating scale (HAM-D 17) [ Time Frame: baseline, 1, 2, and 4 weeks after TMS ] [ Designated as safety issue: No ]
    measuring instrument of severity of depressive symptoms


Biospecimen Retention:   Samples With DNA

serum, plasma and DNAs


Estimated Enrollment: 40
Study Start Date: February 2006
Estimated Study Completion Date: August 2013
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Magnetic stimulation Device: repetitive Transcranial Magnetic Stimulation
10 times repetitive TMS, high frequency
Other Name: 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.

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: September 8, 2010
Last Updated: June 29, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 29, 2014