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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01198561
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Months): 130
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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	Phase
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 Design

• Study Type: Observational
• Anticipated 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: Feb 1, 2006
• Anticipated Primary Completion Date: Dec 1, 2016
• Anticipated Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Hamilton depression rating scale (HAM-D 17) [baseline, 1, 2, and 4 weeks after TMS]

   measuring instrument of severity of depressive symptoms

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul	Kangnam-Ku	Korea, Republic of	135-710

Sponsors and Collaborators

• Samsung Medical Center

Investigators

• Principal Investigator: Doh K KIm, Ph.D, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Doh Kwan Kim, M.D., Ph.D. / Professor, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT01198561
• Other Study ID Numbers: 2005-08-072
• First Posted: Sep 10, 2010
• Last Update Posted: Dec 31, 2015
• Last Verified: Dec 1, 2015

• Keywords provided by Doh Kwan Kim, M.D., Ph.D. / Professor, Samsung Medical Center: repetitive Transcranial Magnetic Stimulation; Major Depressive Disorder
• Additional relevant MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major

Study Results

No Results Posted as of Dec 31, 2015