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

Major Depressive Disorder Clinical Trial

Official title:

Repetitive Transcranial Magnetic Stimulation(rTMS) in the Treatment of Depression : Effect of TMS on Depression, Cognitive Function, and Regional Cerebral Glucose Metabolism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01198561
• Other study ID #: 2005-08-072
• Status: Recruiting
• Phase: N/A
• First received: September 8, 2010
• Last updated: December 30, 2015
• Start date: February 2006
• Est. completion date: December 2016

Study information

• Verified date: December 2015
• Source: Samsung Medical Center
• Contact: Doh Kwan Kim, M.D., Ph.D.
• Phone: 82-2-3410-3582
• Email: paulkim[@]skku.edu
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• repetitive Transcranial Magnetic Stimulation
10 times repetitive TMS, high frequency

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul	Kangnam-Ku

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton depression rating scale (HAM-D 17)	measuring instrument of severity of depressive symptoms	baseline, 1, 2, and 4 weeks after TMS	No