Changes of Functional Connectivity After rTMS in Depression

NCT ID: NCT01325831

Last Updated: 2012-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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Major Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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transcranial magnetic stimluation

Group Type EXPERIMENTAL

repetitive transcranial magnetic stimulation(rTMS)

Intervention Type DEVICE

10-day course of 10 Hz rTMS on left dorsolateral prefrontal cortex of the subjects.

rTMS_sham

Group Type SHAM_COMPARATOR

Sham repetitive transcranial magnetic stimulation(rTMS)

Intervention Type DEVICE

Sham repetitive transcranial magnetic stimulation(rTMS)

Interventions

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repetitive transcranial magnetic stimulation(rTMS)

10-day course of 10 Hz rTMS on left dorsolateral prefrontal cortex of the subjects.

Intervention Type DEVICE

Sham repetitive transcranial magnetic stimulation(rTMS)

Sham repetitive transcranial magnetic stimulation(rTMS)

Intervention Type DEVICE

Other Intervention Names

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MAGSTIM

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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EUN LEE, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yonsei University College of Medicine, Severance Hospital

Locations

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Department of Psychiatry, Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 27379563 (View on PubMed)

Other Identifiers

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4-2008-0525

Identifier Type: -

Identifier Source: org_study_id

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