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Changes of Functional Connectivity After rTMS in Depression

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ClinicalTrials.gov Identifier: NCT01325831
Recruitment Status : Completed
First Posted : March 30, 2011
Last Update Posted : February 2, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Major Depression Device: repetitive transcranial magnetic stimulation(rTMS) Device: Sham repetitive transcranial magnetic stimulation(rTMS) Phase 4

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Change of Dopamine Pathway After rTMS Treatment in Major Depressive Disorder
Study Start Date : May 2009
Primary Completion Date : June 2011
Study Completion Date : June 2011
Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. change of functional connectivity between pre/post rTMS [ Time Frame: 14 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01325831     History of Changes
Other Study ID Numbers: 4-2008-0525
First Posted: March 30, 2011    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: January 2012

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