Transcranial Magnetic Treatment (TMS) in Unipolar Depression

August 2, 2011 updated by: St. Joseph's Healthcare Hamilton

Repetitive Transcranial Magnetic Stimulation (rTMS) in Unipolar Depression

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3K7
        • St.Joseph's Healthcare, rTMS Laboratory, Mood Disorders Program, 100 West Fifth Street

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Major Depression
  • No physical health problems

Exclusion Criteria:

  • History of Epilepsy
  • Metal in the head/neck or skull
  • Pacemaker
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hamilton Depression Rating Scale
Time Frame: Pre TMS and post TMS
Pre TMS and post TMS
Beck Depression Rating Scale
Time Frame: pre TMS and post TMS
pre TMS and post TMS

Secondary Outcome Measures

Outcome Measure
Time Frame
Quantitive Electroencephalographic(QEEG)activity and measures of regional cerebral blood flow
Time Frame: pre TMS and post TMS as well as post phase II, second set of TMS
pre TMS and post TMS as well as post phase II, second set of TMS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Joseph's Healthcare Hamilton

Collaborators

Queen's University, Kingston, Ontario

Investigators

  • Principal Investigator: Gary Hasey, MD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

August 3, 2011

Last Update Submitted That Met QC Criteria

August 2, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMS1871

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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