This is a study to assess the effectiveness of repetitive transcranial magnetic stimulation (rTMS) as a treatment for depressed adults with bipolar disorder. In rTMS high-intensity, fluctuating magnetic fields non-invasively stimulate the cortex of the brain depolarising neurons. No anaesthetic is required and the treatment in subconvulsive. Recent studies suggest that rTMS can be an effective treatment for depressive illness in adults (Loo and Mitchell et al, 2005) and appears to be quite safe. Most of the published studies to date have focused on unipolar depression. There is limited data of TMS use in bipolar depression. Eg. Pilot study by Nahas Z, Kozel FA, Li X, Anderson B, George MS.in 2003, which was negative. The investigators wish to assess this in a sham-controlled study of adults. The investigators hypothesise that both left and right sided rTMS will have an antidepressant effect superior to sham in this population.
Inpatients and outpatients with major depressive episodes as part of either bipolar I or II illness will be eligible. In the event that patients (in any arm) have no significant response after a defined period, they will shift to an open phase where they will receive left prefrontal 10Hz stimulation. Thus all participants will have the opportunity to receive active treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Black Dog Research Institute
Sydney, New South Wales, Australia
Northside Clinic
Sydney, New South Wales, Australia
All measures at baseline and at the end of each week of treatment in the blind phase and after every 2 weeks of treatment in the open phase.
Time frame: weekly
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Weekly
Clinical Global Impressions Scale (CGI)
Time frame: Weekly
Patient Global Improvement scale
Time frame: Weekly
Young Mania Rating Scale
Time frame: weekly
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