Bipolar Affective Disorder Clinical Trial
— TMSOfficial title:
A Randomized, Sham Controlled, Crossover Trial of rTMS for Bipolar Depression
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 |
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)
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | St. Joseph's Healthcare, rTMS Laboratory, Mood Disorder Program, 100 West Fifth Street | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
St. Joseph's Healthcare Hamilton | Queen's University, Kingston, Ontario |
Canada,
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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