Changes of Functional Connectivity After rTMS in Depression

Major Depression Clinical Trial

Official title:

Change of Dopamine Pathway After rTMS Treatment in Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01325831
• Other study ID #: 4-2008-0525
• Status: Completed
• Phase: Phase 4
• First received: July 7, 2009
• Last updated: January 31, 2012
• Start date: May 2009
• Est. completion date: June 2011

Study information

• Verified date: January 2012
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder, Major
• Major Depression

Intervention

Device:
• repetitive transcranial magnetic stimulation(rTMS)
10-day course of 10 Hz rTMS on left dorsolateral prefrontal cortex of the subjects.
• Sham repetitive transcranial magnetic stimulation(rTMS)
Sham repetitive transcranial magnetic stimulation(rTMS)

Locations

Country	Name	City	State
Korea, Republic of	Department of Psychiatry, Severance Hospital	Seoul,

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of functional connectivity between pre/post rTMS		14 days	No