Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder
ConditionMajor Depressive Disorder (MDD)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorCarmen Concerto
About this trial
Introduction The study involves the recruitment of outpatients suffering from Major Depressive Disorder (MDD), diagnosed according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Patients are on selective serotonin reuptake inhibitors (SSRIs) for at least 4 weeks and present residual depressive symptoms, defined by a score greater than 7 on the Hamilton Depression Rating Scale (HDRS-17).
Study Objectives
Primary Objective To investigate the effects of transcranial direct current stimulation (tDCS) on depressive symptoms in patients with depression, randomized into a "test" group and a "sham" group.
Secondary Objectives
To investigate the effects of tDCS on cognitive function in patients with depression, randomized into a "test" group and a "sham" group.
To evaluate changes in blood biomarkers, neurophysiological, and neurosonological variables after tDCS treatment in the same group of patients.
Eligibility criteria
Qualifiers
Patients with Major Depressive Disorder (MDD), as defined by the DSM-5-TR criteria;
Presence of residual symptoms, defined by a Hamilton Depression Rating Scale score over 7;
Age over 18 years.
Disqualifiers
MMSE under 18 and/or CDR over 2;
Other neurological diseases (stroke, multiple sclerosis, major head trauma, epilepsy) or psychiatric disorders other than those included (schizophrenia, bipolar disorder, etc.);
Patients with severe clinical conditions, acute or uncontrolled chronic medical diseases;
Endocrine diseases, vitamin deficiencies, or exposure to drugs associated with cognitive impairment and/or mood deflection;
Trial design
Treatments tested in this trial
- Active tDCS
- Sham treatment
Treatment groups
105 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Carmen Concerto
Lead sponsor
University of Catania
Sponsor institution
Source ClinicalTrials.gov