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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00186784
Other study ID # TMS1871
Secondary ID
Status Completed
Phase Phase 0
First received September 13, 2005
Last updated August 2, 2011
Start date December 2000
Est. completion date July 2011

Study information

Verified date August 2011
Source St. Joseph's Healthcare Hamilton
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

Repetitive Transcranial Magnetic Stimulation (rTMS) can improve mood and decrease sadness in patients with depression.

In this study, the investigators seek to increase their understanding about how rTMS improves depression, and to determine which form of rTMS is most effective for depression, when used in combination with antidepressant medication.


Description:

Patients will be assigned for 4 treatment arms, receiving either left high frequency plus right low frequency, or left high frequency plus right sham, or left sham, plus right low frequency, or left sham plus right sham treatment. All subjects will receive treatments for 10 days and will be followed for another 4 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Major Depression

- No physical health problems

Exclusion Criteria:

- History of Epilepsy

- Metal in the head/neck or skull

- Pacemaker

- Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Transcranial Magnetic Stimulation (TMS)
treatment for 10 days

Locations

Country Name City State
Canada St.Joseph's Healthcare, rTMS Laboratory, Mood Disorders Program, 100 West Fifth Street Hamilton Ontario

Sponsors (2)

Lead Sponsor Collaborator
St. Joseph's Healthcare Hamilton Queen's University, Kingston, Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hamilton Depression Rating Scale Pre TMS and post TMS No
Primary Beck Depression Rating Scale pre TMS and post TMS No
Secondary Quantitive Electroencephalographic(QEEG)activity and measures of regional cerebral blood flow pre TMS and post TMS as well as post phase II, second set of TMS No
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