Major Depressive Disorder Clinical Trial
Official title:
A Double-blind Sham Controlled Trial of Transcranial Direct Current Stimulation (tDCS) in Treating Refractory Major Depressive Disorder (MDD)
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 specialized 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
stimulation vs. active tDCS), longitudinal, treatment outcome trial. Individuals with MDD
will be randomized to 1 of 2 treatment conditions. These will be:
1. Active 2mA 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; the cathode aims to reduce activity in the right prefrontal cortex.
2. Sham treatment: the system setup is identical to that of active tDCS, 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 course (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, Outcomes Assessor), Primary Purpose: Treatment
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