NCT01198561

Brief Summary

The objective of this study is to investigate the antidepressant efficacy of rTMS, and to assess cortical metabolism before and after rTMS sessions in patients with major depression. We also aimed to investigate differences between the responders and nonresponders to rTMS and what would predict clinical response to rTMS.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2010

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 31, 2015

Status Verified

December 1, 2015

Enrollment Period

10.8 years

First QC Date

September 8, 2010

Last Update Submit

December 30, 2015

Conditions

Keywords

repetitive Transcranial Magnetic StimulationMajor Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Hamilton depression rating scale (HAM-D 17)

    measuring instrument of severity of depressive symptoms

    baseline, 1, 2, and 4 weeks after TMS

Study Arms (1)

repetitive Transcranial Magnetic Stimulation

repetitive Transcranial Magnetic Stimulation is a depressive patient group treated with rTMS

Device: repetitive Transcranial Magnetic Stimulation

Interventions

10 times repetitive TMS, high frequency

repetitive Transcranial Magnetic Stimulation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with major depressive disorder, who were not responsive to antidepressants

You may qualify if:

  • Twenty patients fulfilling the diagnostic criteria of major depression according to DSM IV will be enrolled in the study.
  • Antidepressant medication will be maintained throughout the study period.

You may not qualify if:

  • To exclude the effect of drug changes on post-rTMS cerebral glucose metabolism, the combinations and dosage of pre-rTMS antidepressant drugs will remain unchanged until the post-rTMS 18FDG PET is done.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, Kangnam-Ku, 135-710, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma and DNAs

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Doh K KIm, Ph.D

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Doh Kwan Kim, M.D., Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D. / Professor

Study Record Dates

First Submitted

September 8, 2010

First Posted

September 10, 2010

Study Start

February 1, 2006

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 31, 2015

Record last verified: 2015-12

Locations