Efficacy Study of Transcranial Direct Current Stimulation to Treat Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): transcranial direct current stimulation; Sertraline; double placebo
Intervention type(s): Device; Drug; Other
Intervention description(s): Transcranial direct current stimulation will be applied at 2mA, 30 minutes/day, for 10 weekdays consecutively and two extra stimulations at week 4 and 6.; Patient will receive sertraline 50mg/day.; double placebo arm (sham stimulation/placebo pill)
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depressive Disorder, Major