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

• Conditions: Major Depressive Disorder
• Interventions: Device: repetitive Transcranial Magnetic Stimulation

• Registration Number: NCT01198561
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-02
• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-09-08
• Study First Posted: 2010-09-10
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-30
• Last Update Posted: 2015-12-31
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
repetitive Transcranial Magnetic Stimulation	repetitive Transcranial Magnetic Stimulation	repetitive Transcranial Magnetic Stimulation is a depressive patient group treated with rTMS

Primary Outcome Measures

Name	Time	Method
Hamilton depression rating scale (HAM-D 17)	baseline, 1, 2, and 4 weeks after TMS	measuring instrument of severity of depressive symptoms

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Kangnam-Ku, Korea, Republic of