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The project will investigate the use of a novel neuromodulatory technique, transcranial direct current stimulation (tDCS) in the treatment of patients with major depressive disorder.
Hypothesis 1: Active tDCS will improve depressive symptomology to a significantly greater degree than sham treatment.
Hypothesis 2: Active tDCS will be well tolerated and free of major side effects.
Major depression is a disorder with major clinical and economic significance locally and internationally. It is a disorder of high prevalence and results in substantial disease burden and health-care costs. Critically, a significant percentage of patients, usually estimated at around 30%, fail to respond to standard treatments (Fitzgerald 2003). Techniques such as repetitive transcranial magnetic stimulation (rTMS) are being investigated widely for the treatment of this disorder with considerable success in recent years (Fitzgerald, Benitez et al. 2006; Hasey 2001). However, TMS equipment is expensive and requires specialist application. Additionally, TMS is associated with some side-effects (e.g. seizures). Given that depression occurs in all cultures and countries, there would be considerable value in developing a low-cost, non-invasive technique that can be applied in a wide variety of settings and which has already been shown to have some efficacy in MDD (Boggio et al. 2007).
The proposed study will be a randomized, double blind, placebo-controlled (i.e., sham vs. tDCS), longitudinal, treatment outcome trial. Individuals with depression will be randomized to 1 of 2 treatment conditions. These will be:
1. Active 2mA transcranial direct current stimulation (tDCS): in this condition, 1 stimulator will be used with anodal stimulation to the left prefrontal cortex and cathodal stimulation to the right prefrontal cortex. The placement of anodal stimulation is proposed to enhance activity in the left frontal cortex; and the cathode aims to reduce activity in the right prefrontal cortex.
2. Sham treatment: the system will be set up as for condition one but the stimulator will be turned off after 30 seconds.
A total of 15 treatments will be administered to all participants over 3 weeks (one per working day). Individuals will be randomized on a computer-generated list. Clinical raters and patients will be blind to the treatment condition. Clinical ratings well be conducted prior to and after the treatment (i.e., after 3 weeks). All subjects randomized to sham treatment will be offered active treatment at the end of the acute treatment phase.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Major Depressive Disorder
transcranial direct current stimulation (tDCS), Sham treatment
Centre for Addiction and Mental Health
Centre for Addiction and Mental Health
Published on BioPortfolio: 2014-08-27T03:15:30-0400
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