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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00186758
Other study ID # TMS2092
Secondary ID
Status Completed
Phase Phase 4
First received September 13, 2005
Last updated August 2, 2011
Start date July 2002
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

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)


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
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:

- Bipolar Depression

- no physical health problems

Exclusion Criteria:

- Metal in head/neck or skull

- History of Epilepsy

- Pregnancy

- Pacemaker

Study Design

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


Intervention

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 -

Locations

Country Name City State
Canada St. Joseph's Healthcare, rTMS Laboratory, Mood Disorder 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 To compare antidepressant efficacy of right, left to sham within 9 weeks No
Secondary To determine if QEEG activity correlates with antidepressant response to rTMS within 9 weeks No
Secondary To determine if non-responders can become responders if treating the opposite hemisphere within 9 weeks No
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