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Transcranial Magnetic Stimulation in Bipolar Depression (TMS)

This study has been completed.
Sponsor:
Collaborator:
Queen's University, Kingston, Ontario
Information provided by:
St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier:
NCT00186758
First received: September 13, 2005
Last updated: August 2, 2011
Last verified: August 2011
History of Changes
  Purpose

To compare antidepressant efficacy of left or right to sham Repetitive Transcranial Magnetic Stimulation (rTMS)

to determine if non-responders can become responders if treated on the other side of the hemisphere

(rTMS)


Condition Intervention Phase
Bipolar Affective Disorder
 Device: Transcranial Magnetic Stimulation (TMS)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Sham Controlled, Crossover Trial of rTMS for Bipolar Depression

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • To compare antidepressant efficacy of right, left to sham [ Time Frame: within 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine if QEEG activity correlates with antidepressant response to rTMS [ Time Frame: within 9 weeks ] [ Designated as safety issue: No ]
  • To determine if non-responders can become responders if treating the opposite hemisphere [ Time Frame: within 9 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2002
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: 1, Phase l, True or Sham
this treatment will be True or Sham (placebo) on one side of the head, phase I
 Device: Transcranial Magnetic Stimulation (TMS)

Phase l clients receive either True or Sham TMS treatments on left or right side of head for 10 days.

Phase ll clients will receive either Sham or True TMS treatments on the other side of the head - the same type as in phase l -

Other Names:
  • HamD
  • BDI II
  • VAS
Active Comparator: 2, phase ll, Sham or True
This treatment will be Sham(placebo)or True on the other side of the head phase II.
 Device: Transcranial Magnetic Stimulation (TMS)

Phase l clients receive either True or Sham TMS treatments on left or right side of head for 10 days.

Phase ll clients will receive either Sham or True TMS treatments on the other side of the head - the same type as in phase l -

Other Names:
  • HamD
  • BDI II
  • VAS

Detailed Description:

Patients will be assigned to one of 3 treatment arms for 10 days of treatment with either left high frequency or right high frequency, or sham rTMS. After 10 days of treatment, and no improvement, another 10 days of treatment follows, this time with the coil placed on the other hemisphere. Subjects will be followed for 2 months respectively with unrestricted treatment provided by their regular physician. Mood stabilizers will be continued throughout this trial.

  Eligibility

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

Inclusion Criteria:

  • Bipolar Depression
  • no physical health problems

Exclusion Criteria:

  • Metal in head/neck or skull
  • History of Epilepsy
  • Pregnancy
  • Pacemaker
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00186758

Locations
Canada, Ontario
St. Joseph's Healthcare, rTMS Laboratory, Mood Disorder 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 Hasey, Director, TMS Laboratory, McMaster University
ClinicalTrials.gov Identifier: NCT00186758     History of Changes
Other Study ID Numbers: TMS2092
Study First Received: September 13, 2005
Last Updated: August 2, 2011
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Mood Disorders
 Affective Disorders, Psychotic
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on June 18, 2013