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Changes of Functional Connectivity After rTMS in Depression

Primary Purpose

Major Depression

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
repetitive transcranial magnetic stimulation(rTMS)
Sham repetitive transcranial magnetic stimulation(rTMS)
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychiatry, Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

transcranial magnetic stimluation

rTMS_sham

Arm Description

Outcomes

Primary Outcome Measures

change of functional connectivity between pre/post rTMS

Secondary Outcome Measures

Full Information

First Posted
July 7, 2009
Last Updated
January 31, 2012
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01325831
Brief Title
Changes of Functional Connectivity After rTMS in Depression
Official Title
Change of Dopamine Pathway After rTMS Treatment in Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
transcranial magnetic stimluation
Arm Type
Experimental
Arm Title
rTMS_sham
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
repetitive transcranial magnetic stimulation(rTMS)
Other Intervention Name(s)
MAGSTIM
Intervention Description
10-day course of 10 Hz rTMS on left dorsolateral prefrontal cortex of the subjects.
Intervention Type
Device
Intervention Name(s)
Sham repetitive transcranial magnetic stimulation(rTMS)
Intervention Description
Sham repetitive transcranial magnetic stimulation(rTMS)
Primary Outcome Measure Information:
Title
change of functional connectivity between pre/post rTMS
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EUN LEE, M.D., Ph.D.
Organizational Affiliation
Yonsei University College of Medicine, Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, Severance Hospital
City
Seoul,
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
27379563
Citation
Kang JI, Lee H, Jhung K, Kim KR, An SK, Yoon KJ, Kim SI, Namkoong K, Lee E. Frontostriatal Connectivity Changes in Major Depressive Disorder After Repetitive Transcranial Magnetic Stimulation: A Randomized Sham-Controlled Study. J Clin Psychiatry. 2016 Sep;77(9):e1137-e1143. doi: 10.4088/JCP.15m10110.
Results Reference
derived

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Changes of Functional Connectivity After rTMS in Depression

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