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Completed

NCT Number: NCT01325831

Changes of Functional Connectivity After rTMS in Depression

In order to explore the effect of repetitive TMS, which has shown to be effective in intractable depression, we will examine resting-state, default-mode network functional connectivity in patients with major depression. We will use a double-blind, sham-controlled design. Our target sample size is 60(30 patients will be treated by active rTMS, the other 30 will be treated by sham rTMS). We will apply 10-day course of 10 Hz rTMS on left dorsolateral prefrontal cortex of the subjects.

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Key information

Conditions

Major Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Psychiatry, Severance Hospital

Seoul, 120-752, South Korea

About this study

Up to now, 24 patients with major depression and 6 normal controls are enrolled. Twenty-three patients and 4 normal participants have taken 10 days rTMS. One patients and one control withdrew their consent without any reason and one control withdrew the consent because of headache.

We scanned fMRIs(to examine functional connectivity)twice for each participant, which were taken 3 days before the first and 3 days after the last rTMS.

All of participants have not reported side effects except mild headahe. There's been no seizure event up to now.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • DSM-IV major depressive episode
  • Failure of at least 3 different kind of antidepressant

Exclusion criteria

  • Organic brain disorder
  • Other diagnosis of DMS-IV except nicotine dependence
  • History of seizure disorder

Treatment and study plan

repetitive transcranial magnetic stimulation(rTMS)

Device

10-day course of 10 Hz rTMS on left dorsolateral prefrontal cortex of the subjects.

Other names: MAGSTIM

Sham repetitive transcranial magnetic stimulation(rTMS)

Device

Sham repetitive transcranial magnetic stimulation(rTMS)

Primary outcomes

  1. change of functional connectivity between pre/post rTMS

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

Change of Dopamine Pathway After rTMS Treatment in Major Depressive Disorder

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 30, 2011
Registry last updated
Feb 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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