NCT06714643Not yet recruiting
Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder
Antidepressant and Related Neurophysiological Effects of Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder
Source: ClinicalTrials.gov · Last updated 3 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 105 (estimated)
- First submitted
- 16 Sept 2024
- Start date
- 2 Jan 2025
- Primary completion date
- 2 Jan 2026
- Lead sponsor
- Carmen Concerto
- Diseases
- Depression
- NCT number
- NCT06714643
What you commit to
- Study type: Interventional
- Planned participants: 105
- From 2 Jan 2025 to the primary completion date, 2 Jan 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Alcohol abuse or recreational drug use;
Other illness
- 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;
- Contraindications to MRI and TMS (carriers of implanted devices, patients who have undergone craniotomy, presence of metal fragments or prostheses, history of epilepsy);
Other
- MMSE under 18 and/or CDR over 2;
- Pregnant or breastfeeding women.
Who the study is looking for
- 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.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.