Depressive Disorder, Major Clinical Trial
Official title:
A Factorial, Double-blinded, Randomized Clinical Trial on Major Depressive Disorder Using Transcranial Direct Current Stimulation
The purpose of this study is to determine whether transcranial direct current stimulation is an effective treatment for major depression, when compared (and combined) to sertraline and placebo.
Major Depressive Disorder (MDD) is a common mental disorder, with a lifetime prevalence of
15% and an incidence of 5% per year. Its core symptoms include lack of pleasure in daily
activities, thoughts of guilt and depressed mood. According to the World Health
Organization, MDD is one of the ten most impairing conditions, leading to missing workdays,
loss of quality of life and increasing expenses in health care. Besides, about 1% of
patients with MDD complete suicide. Moreover, one third of patients with MDD remain
depressed after more than two adequate treatments, i.e., they are refractory to conventional
antidepressant treatments; also, most treated patients remain with residual symptoms.
Therefore, the development of new treatments is necessary. Transcranial direct current
stimulation (tDCS) is a novel, promising technique in the study of several neuropsychiatric
conditions.
Transcranial DCS is a non-invasive brain stimulation method in which a low intensity direct
current is applied through the skull, with neurophysiologic studies showing that a
considerable amount of electrical current reach the brain tissues, vis-à-vis the specified
parameters. Thus, the DC could be applied over brain MDD-related areas, such as the
dorsolateral prefrontal cortex, thereby leading to neuroplasticity and MDD treatment.
Indeed, some pilot studies showed that tDCS might ameliorate depressive symptoms. However,
it is necessary to replicate these findings in larger populations to increase the
generalizability of the results and to verify the efficacy of the intervention. Our aim is
to perform a double blind, randomized, factorial study comparing tDCS and sertraline for MDD
treatment, enrolling 120 eligible patients of both genders between 21-65 years not
presenting active suicidal ideation. They will be allocated in 4 groups at random to receive
active tDCS or sham and sertraline 50mg/day or placebo. Transcranial DCS will be applied in
a daily basis for 10 consecutive working days (2 weeks), after that, the patients will be
followed weekly for 6 weeks. Our primary outcome is the depression rating scores at 6 weeks,
measured by the Hamilton Depression Rating Scale (HDRS), 17-itens. In conclusion, our
purpose is to perform a clinical tDCS study to verify its efficacy in the treatment of MDD
in a sample of patients of several levels of severity and refractoriness.
Our secondary objectives are also to verify the safety of the intervention as well as to
compare tDCMajor Depressive Disorder (MDD) is a common mental disorder, with a lifetime
prevalence of 15% and an incidence of 5% per year. Its core symptoms include lack of
pleasure in daily activities, thoughts of guilt and depressed mood. According to the World
Health Organization, MDD is one of the ten most impairing conditions, leading to missing
workdays, loss of quality of life and increasing expenses in health care. Besides, about 1%
of patients with MDD complete suicide. Moreover, one third of patients with MDD remain
depressed after more than two adequate treatments, i.e., they are refractory to conventional
antidepressant treatments; also, most treated patients remain with residual symptoms.
Therefore, the development of new treatments is necessary. Transcranial direct current
stimulation (tDCS) is a novel, promising technique in the study of several neuropsychiatric
conditions.
Transcranial DCS is a non-invasive brain stimulation method in which a low intensity direct
current is applied through the skull, with neurophysiologic studies showing that a
considerable amount of electrical current reach the brain tissues, vis-à-vis the specified
parameters. Thus, the DC could be applied over brain MDD-related areas, such as the
dorsolateral prefrontal cortex, thereby leading to neuroplasticity and MDD treatment.
Indeed, some pilot studies showed that tDCS might ameliorate depressive symptoms. However,
it is necessary to replicate these findings in larger populations to increase the
generalizability of the results and to verify the efficacy of the intervention. Our aim is
to perform a double blind, randomized, factorial study comparing tDCS and sertraline for MDD
treatment, enrolling 120 eligible patients of both genders between 21-65 years not
presenting active suicidal ideation. They will be allocated in 4 groups at random to receive
active tDCS or sham and sertraline 50mg/day or placebo. Transcranial DCS will be applied in
a daily basis for 10 consecutive working days (2 weeks), after that, the patients will be
followed weekly for 6 weeks. Our primary outcome is the depression rating scores at 6 weeks,
measured by the Hamilton Depression Rating Scale (HDRS), 17-itens. In conclusion, our
purpose is to perform a clinical tDCS study to verify its efficacy in the treatment of MDD
in a sample of patients of several levels of severity and refractoriness.
Our secondary objectives are also to verify the safety of the intervention as well as to
compare tDCS vs. sertraline and the association of sertraline and tDCS vs. each treatment
alone in major depression treatment.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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