Bipolar Disorder Clinical Trial
Official title:
A Sham-controlled Study of Transcranial Direct Current Stimulation (tDCS) as a Treatment for Depression
Depression is a common illness with an approximate lifetime prevalence of 17 %, conferring a
large burden of disease in the community, often due to inadequate treatment. Thus there is
interest in the therapeutic potential of non invasive, novel forms of brain stimulation,
such as transcranial direct current stimulation (tDCS). Two small studies have been
published in the last two years indicating that 20 minutes of either 1 or 2mA tDCS over 5 or
10 sessions is safe, painless and well tolerated. The investigators' own pilot data (N=30)
also suggests the technique has antidepressant effects and is safe (5-10 sessions of tDCS at
1 mA).
This study will extend previous findings, testing a more definitive tDCS approach (also left
prefrontal anodal stimulation) with a longer treatment course (15 sessions), at 2 mA (which
has been found to be safe and more effective than 1 mA in cognitive studies), and in a
larger sample (N=68), using a placebo-controlled design.
It is hypothesised that active tDCS (15 sessions) will have greater efficacy than sham
treatment (15 sessions) in reducing the severity of depressive symptoms in patients in an
episode of major depression. A second hypothesis is that 15 sessions of tDCS will not cause
any significant adverse effects or cause decline in neuropsychological functioning in
comparison to a sham control.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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