Transcranial Magnetic Treatment (TMS) in Unipolar Depression

This study has been completed.
Sponsor:
Collaborator:
Queen's University, Kingston, Ontario
Information provided by:
St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT00186784
First received: September 13, 2005
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Unipolar Depression
Procedure: Transcranial Magnetic Stimulation (TMS)
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation (rTMS) in Unipolar Depression

Resource links provided by NLM:


Further study details as provided by St. Joseph's Healthcare Hamilton:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale [ Time Frame: Pre TMS and post TMS ] [ Designated as safety issue: No ]
  • Beck Depression Rating Scale [ Time Frame: pre TMS and post TMS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: December 2000
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Transcranial Magnetic Stimulation (TMS)
    treatment for 10 days
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major Depression
  • No physical health problems

Exclusion Criteria:

  • History of Epilepsy
  • Metal in the head/neck or skull
  • Pacemaker
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00186784

Locations
Canada, Ontario
St.Joseph's Healthcare, rTMS Laboratory, Mood Disorders Program, 100 West Fifth Street
Hamilton, Ontario, Canada, L8N 3K7
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
Queen's University, Kingston, Ontario
Investigators
Principal Investigator: Gary Hasey, MD McMaster University
  More Information

No publications provided

Responsible Party: Dr. Gary M. Hasey, St. Joseph's Healthcare
ClinicalTrials.gov Identifier: NCT00186784     History of Changes
Other Study ID Numbers: TMS1871
Study First Received: September 13, 2005
Last Updated: August 2, 2011
Health Authority: Canada: Health Canada

Keywords provided by St. Joseph's Healthcare Hamilton:
Repetitive Transcranial Magnetic Stimulation
TMS

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014