Changes of Functional Connectivity After rTMS in Depression
Change of Dopamine Pathway After rTMS Treatment in Major Depressive Disorder
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2009
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 7, 2009
CompletedFirst Posted
Study publicly available on registry
March 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFebruary 2, 2012
January 1, 2012
2.1 years
July 7, 2009
January 31, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
change of functional connectivity between pre/post rTMS
14 days
Study Arms (2)
transcranial magnetic stimluation
EXPERIMENTALrTMS_sham
SHAM COMPARATORInterventions
10-day course of 10 Hz rTMS on left dorsolateral prefrontal cortex of the subjects.
Sham repetitive transcranial magnetic stimulation(rTMS)
Eligibility Criteria
You may qualify if:
- DSM-IV major depressive episode
- Failure of at least 3 different kind of antidepressant
You may not qualify if:
- Organic brain disorder
- Other diagnosis of DMS-IV except nicotine dependence
- History of seizure disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychiatry, Severance Hospital
Seoul, 120-752, South Korea
Related Publications (1)
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.
PMID: 27379563DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
EUN LEE, M.D., Ph.D.
Yonsei University College of Medicine, Severance Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2009
First Posted
March 30, 2011
Study Start
May 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
February 2, 2012
Record last verified: 2012-01