Major Depressive Disorder (MDD)NIBS_tDCSNCT06714643
Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder
A study testing Active tDCS in people with Major Depressive Disorder (MDD), run by Carmen Concerto.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2025to 2 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- Alcohol abuse or recreational drug use;
- Contraindications to MRI and TMS (carriers of implanted devices, patients who have undergone craniotomy, presence of metal fragments or prostheses, history of epilepsy);
- Pregnant or breastfeeding women.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Carmen Concerto, MD PhD contact
About this study
Official title: Antidepressant and Related Neurophysiological Effects of Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder
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
Read more
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.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Active tDCS, Sham treatment
- Keywords
- tDCS, MD, Biomarkers
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
The active tDCS protocol consist of 15 excitatory tDCS sessions distributed over 3 weeks (5 sessions per week, from Monday to Friday), at the same time each day, administered by the same operators and under identical experimental conditions. Each session last 30 minutes, with the Anode electrode placed on the left dorsal lateral prefrontal cortex (DLPFC) and the Cathode electrode on the right DLPFC at an intensity of 2 mA. The electrodes are positioned according to the 10-20 electroencephalography system (Anode on F3 and Cathode on F4).
Sham treatmentDevice
The sham-tDCS intervention consist of a placebo 15 tDCS sessions distributed over 3 weeks (5 sessions per week, from Monday to Friday), at the same time each day, administered by the same operators and under identical experimental conditions. Each session last 30 minutes, with the Anode electrode placed on the left dorsal lateral prefrontal cortex (DLPFC) and the Cathode electrode on the right DLPFC. During the sessions only a 15-second initiation current is applied, providing the patient with the sensation of receiving an electric current on the scalp. Participants will also experience sounds and stimuli similar to those produced by active tDCS.
| Study group | Role | What they receive |
|---|---|---|
| active | Experimental | Not described Receives: Device: Active tDCS |
| sham | Sham comparator | Not described Receives: Device: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale - 17 (HDRS-17)
To investigate the effects of transcranial direct current stimulation (tDCS) treatment by administering Hamilton Depression Rating Scale - 17 (HDRS-17) on depressive symptoms in patients with depression, randomized into a "test" group and a "sham" group. Higher scores indicate greater severity of depressive symptoms, and thus a worse outcome.
The minimum and maximum scores and their meaning are as follows: 0-7: No clinically significant depression; 8-13: mild depression; 14-18: moderate depression; 19-22: severe depression; 23-52: very severe depression.
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (7)
Montreal Cognitive Assessment (MOCA)
To investigate the effects of tDCS treatment on cognitive function in patients with depression, randomized into a "test" group and a "sham" group.
Lower scores suggest greater cognitive impairment, while higher scores indicate better cognitive performance. Below are the minimum and maximum scores and their meaning: 30-26: normal cognitive function; 25-18: mild cognitive impairment; 17-10: moderate cognitive impairment; 9-0: severe cognitive impairment.
Measured: From enrollment to the end of treatment at 6 months
Frontal Assessment Battery (FAB)
To investigate the effects of tDCS treatment on cognitive function in patients with depression, randomized into a "test" group and a "sham" group. Specifically, FAB is a tool used to evaluate frontal lobe functions, such as executive functioning. Lower scores suggest greater impairment of frontal lobe functions, while higher scores indicate better functioning. Below are the minimum and maximum scores and their meaning: 18-15: normal frontal lobe functioning; 14-12: mild impairment; 11-9: moderate impairment; 9-0: severe impairment.
Measured: From enrollment to the end of treatment at 6 months
Apathy Evaluation Scale (AS)
To investigate the effects of tDCS treatment on cognitive function in patients with depression, randomized into a "test" group and a "sham" group. AS is a tool used to assess the presence of apathy in patients. Higher scores suggest greater severity of apathy, while lower scores indicate better motivation and engagement. Below are the minimum and maximum scores and their meaning: 18-27: no clinically significant apathy; 28-41: mild apathy; 42-55: moderate apathy; 56-72: severe apathy.
Measured: From enrollment to the end of treatment at 6 months
Stroop Color Test
To investigate the effects of tDCS treatment on cognitive function in patients with depression, randomized into a "test" group and a "sham" group. Stroop Color Test is a neuropsychological tool used to assess cognitive flexibility, selective attention and processing speed. Performance is assessed by comparing raw scores to normative data adjusted for age, education and cultural background. Minimum score (0) indicates no ability to perform the task; on the other hand, there is no universal maximum score. Tipically, performance is categorized into a normal range when it is consistent with age-matched norms; mild impairment when the performance is slightly below expectations for age or education; moderate to severe impairment when patient shows significant difficulty with cognitive control or selective attention.
Measured: From enrollment to the end of treatment at 6 months
To evaluate changes in blood biomarkers after tDCS treatment
A blood sample is collected at enrollment and after tDCS/sham treatment to evaluate biomarkers, including BDNF, NGF, VEGF, IGF1, Ang, Nrg1, IL-6, and TNFα.
Concentrations will be reported in pg/mL or ng/mL, as appropriate for each biomarker.
Measured: From enrollment to the end of treatment at 6 months
To evaluate changes in cerebral hemodynamics after tDCS treatment
A transcranial Doppler (TCD) exam is conducted to assess cerebral hemodynamics. Parameters including VPS (cm/s), EDV (cm/s), MBFV (cm/s), PI (unitless), and RI (unitless) are recorded bilaterally from the middle cerebral arteries and the basilar artery, both at rest and after breath-holding tests. Measurements will be reported in their respective units (e.g., cm/s for velocities, unitless for indices).
Measured: From enrollment to the end of treatment at 6 months
To evaluate changes in Cortical Excitability Using TMS
Cortical excitability is evaluated using transcranial magnetic stimulation (TMS) with single- and double-pulse protocols. Parameters include:
Resting motor threshold (rMT, % of maximum stimulator output); Cortical silent period (cSP, milliseconds); Motor evoked potential (MEP, µV); Paired-pulse stimulation (BiSTIM) is used to study inhibitory and excitatory circuits, including intracortical inhibition (ICI) and intracortical facilitation (ICF).
Results are reported in their respective units (e.g., % stimulator output for rMT, ms for cSP, µV for MEP).
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start2 Jan 2025 (estimated)
- Primary completion2 Jan 2026 (estimated)
- Study completion2 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmen Concerto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carmen Concerto, University of Catania
- Investigators
- Maria Salvina Signorelli, MD PhD, Principal investigator, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714643
- Sponsor's protocol ID
- 130/2022/PO
- Acronym
- NIBS_tDCS
- Status last verified
- Nov 2024
- First submitted
- 16 Sep 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antidepressant and Related Neurophysiological Effects of Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT06714643
- Acronym / sponsor ID
- NIBS_tDCS / 130/2022/PO
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- tDCS, MD, Biomarkers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Carmen ConcertoUniversity, hospital or other
- Study start
- 2 Jan 2025 (estimated)
- Primary completion
- 2 Jan 2026 (estimated)
- Study completion
- 2 Jan 2026 (estimated)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active | Experimental | Device: Active tDCS |
| sham | Sham comparator | Device: Sham treatment |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
- Alcohol abuse or recreational drug use;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active tDCSThe active tDCS protocol consist of 15 excitatory tDCS sessions distributed over 3 weeks (5 sessions per week, from Monday to Friday), at the same time each day, administered by the same operators and under identical experimental conditions. Each session last 30 minutes, with the Anode electrode placed on the left dorsal lateral prefrontal cortex (DLPFC) and the Cathode electrode on the right DLPFC at an intensity of 2 mA. The electrodes are positioned according to the 10-20 electroencephalography system (Anode on F3 and Cathode on F4). | Device | active |
| Sham treatmentThe sham-tDCS intervention consist of a placebo 15 tDCS sessions distributed over 3 weeks (5 sessions per week, from Monday to Friday), at the same time each day, administered by the same operators and under identical experimental conditions. Each session last 30 minutes, with the Anode electrode placed on the left dorsal lateral prefrontal cortex (DLPFC) and the Cathode electrode on the right DLPFC. During the sessions only a 15-second initiation current is applied, providing the patient with the sensation of receiving an electric current on the scalp. Participants will also experience sounds and stimuli similar to those produced by active tDCS. | Device | sham |
Primary outcome
Hamilton Depression Rating Scale - 17 (HDRS-17)
Time frame: From enrollment to the end of treatment at 6 months
To investigate the effects of transcranial direct current stimulation (tDCS) treatment by administering Hamilton Depression Rating Scale - 17 (HDRS-17) on depressive symptoms in patients with depression, randomized into a "test" group and a "sham" group. Higher scores indicate greater severity of depressive symptoms, and thus a worse outcome. The minimum and maximum scores and their meaning are as follows: 0-7: No clinically significant depression; 8-13: mild depression; 14-18: moderate depression; 19-22: severe depression; 23-52: very severe depression.
7 secondary outcomes
Montreal Cognitive Assessment (MOCA)
Time frame: From enrollment to the end of treatment at 6 months
Frontal Assessment Battery (FAB)
Time frame: From enrollment to the end of treatment at 6 months
Apathy Evaluation Scale (AS)
Time frame: From enrollment to the end of treatment at 6 months
Stroop Color Test
Time frame: From enrollment to the end of treatment at 6 months
To evaluate changes in blood biomarkers after tDCS treatment
Time frame: From enrollment to the end of treatment at 6 months
To evaluate changes in cerebral hemodynamics after tDCS treatment
Time frame: From enrollment to the end of treatment at 6 months
To evaluate changes in Cortical Excitability Using TMS
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carmen Concerto, MD PhD contact
Maria Salvina Signorelli, MD PhD principal investigator
University of Catania
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS in people with Major Depressive Disorder (MDD), run by Carmen Concerto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Salvina Signorelli, MD PhD (3498127364, maria.signorelli@unict.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale - 17 (HDRS-17) (time frame: From enrollment to the end of treatment at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.