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Changes of Functional Connectivity After rTMS in Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01325831
First received: July 7, 2009
Last updated: January 31, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Major Depression
 Device: repetitive transcranial magnetic stimulation(rTMS)
Device: Sham repetitive transcranial magnetic stimulation(rTMS)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Change of Dopamine Pathway After rTMS Treatment in Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • change of functional connectivity between pre/post rTMS [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: May 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: transcranial magnetic stimluation Device: repetitive transcranial magnetic stimulation(rTMS)
10-day course of 10 Hz rTMS on left dorsolateral prefrontal cortex of the subjects.
Other Name: MAGSTIM
Sham Comparator: rTMS_sham Device: Sham repetitive transcranial magnetic stimulation(rTMS)
Sham repetitive transcranial magnetic stimulation(rTMS)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01325831

Locations
Korea, Republic of
Department of Psychiatry, Severance Hospital
Seoul,, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: EUN LEE, M.D., Ph.D. Yonsei University College of Medicine, Severance Hospital
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01325831     History of Changes
Other Study ID Numbers: 4-2008-0525
Study First Received: July 7, 2009
Last Updated: January 31, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
 Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013