PARKINSON DISEASE (Disorder)tDCS&PDNCT06885138

Clinical and Neurophysiological Effects of tDCS on Depression in Parkinson's Disease

A study testing active transcranial Direct Current Stimulation in people with PARKINSON DISEASE (Disorder), run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 35 to 75 years
Conditions the study is for: PARKINSON DISEASE (Disorder)
What is being tested?: active transcranial Direct Current Stimulation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 52 participants
Where: 1 siteItaly
Study dates: 23 Apr 2024to Feb 2027
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 35 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of idiopathic Parkinson's disease according to the clinical diagnostic criteria of the Movement Disorder Society;
No dementia (Montreal Cognitive Assessment score ≥ 22/30);
Presence of depressive symptoms
Pharmacological treatment for motor symptoms stable for at least 1 month
Treatment (pharmacological/non-pharmacological) for depressive symptoms stable for at least 3 months.

Who cannot join

Patients with a pacemaker, intracranial electrodes, implanted defibrillators, or any other type of prosthesis;
Patients undergoing Deep Brain Stimulation treatment;
Patients with epilepsy or a history of seizures;
Patients with psychosis;
Patients with a history of skull fracture;
Pregnant/breastfeeding patients;

Show all 9Show fewer

Patients with suicidal ideation or a suicide attempt in the six months prior to the start of the study;
Patients with a history of substance dependence or abuse;
Concomitant treatment with medications that may affect tDCS (benzodiazepines, anticonvulsants, pseudoephedrine, dextromethorphan).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122

Other trials in Italy

About this study

Official title: Study of the Clinical and Neurophysiological Effects of Transcranial Direct Current Stimulation on Depressive Symptoms in Parkinson's Disease.

Parkinson's disease (PD) is the second most common neurodegenerative disorder, characterized by dopaminergic cell degeneration leading to neurophysiological alterations and a heterogeneous clinical presentation. In addition to motor symptoms, PD patients often experience non-motor symptoms, particularly neuropsychiatric manifestations such as depression, anxiety, and apathy. Depression is one of the most prevalent behavioral symptoms, affecting at least 50% of PD patients, with a higher incidence compared to the general population and other disabling conditions. Two main hypotheses explain the emergence of depressive symptoms: one considers depression a reactive response to progressive disability, while the other links it to the underlying neurobiological mechanisms of PD. Additionally, depression and anxiety frequently co-occur in PD, suggesting shared neurobiological pathways.

Conventional pharmacological treatments only partially address affective symptoms in PD, highlighting the need for innovative non-pharmacological therapies. Transcranial direct current stimulation (tDCS) has gained attention as a potential treatment, showing promising results in improving both motor and affective symptoms in PD. While preliminary studies suggest that tDCS may significantly reduce depressive symptoms, current evidence is insufficient to establish clinical recommendations, necessitating further large-scale, randomized controlled trials.

Objectives

The primary objective of this study is to evaluate the effects of repeated tDCS sessions on depressive symptoms in PD patients. Secondary objectives include:

Assessing the potential impact of repeated tDCS sessions on anxiety, apathy, sleep quality, and quality of life in PD patients.
Investigating the neurophysiological mechanisms underlying depression and the effects induced by tDCS.

Methodology

Eligible patients will be randomly assigned to one of two groups:

Experimental Group: Patients will receive repeated sessions of active tDCS (anodal stimulation). The active electrode (35 cm²) will be placed over the left dorsolateral prefrontal cortex (DLPFC), with the reference electrode (35 cm²) on the contralateral area. Stimulation intensity will be set at 2mA, and each session will last 20 minutes.
Control Group: Patients will receive sham tDCS sessions. Electrodes will be positioned identically to the active condition, but the current will only be applied for the first 5 seconds to prevent perception of the sham condition while ensuring no neuromodulatory effects. Each session will last 20 minutes.

Both groups will undergo tDCS sessions on days 1, 2, 3, 4, 5, 12, 19, and 26 of the study.

Assessment and Outcome Measures tDCS treatment will be administered in a hospital setting using the Newronika stimulator (CE-certified medical device). The effects on depressive symptoms and neurophysiological mechanisms will be evaluated using validated clinical scales and neurophysiological assessments at multiple time points:

T0 (Day 1): Baseline assessment before treatment initiation.
T1 (Day 5): After one week of treatment.
T5 (Day 33): One week after completing all treatment sessions.
T6 (Day 54): One month after treatment completion.

This study aims to improve the understanding of tDCS's clinical efficacy and underlying mechanisms in managing affective symptoms in PD. The findings could support the development of evidence-based non-pharmacological interventions for PD patients.

Conditions: PARKINSON DISEASE (Disorder)
Being tested: active transcranial Direct Current Stimulation, sham transcranial Direct Current Stimulation
Keywords: Depression, Parkinson Disease, tDCS
Medical subject headings: Parkinson Disease, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

active transcranial Direct Current StimulationDevice
Also called Neuromodulation
Patients will undergo repeated sessions of active transcranial Direct Current Stimulation (tDCS) (anodal polarity). The active electrode (35 cm²) will be placed over the left dorsolateral prefrontal cortex (DLPFC), while the reference electrode (35 cm²) will be positioned over the contralateral area, with a stimulation intensity of 2mA.
Patients will undergo a tDCS session on days 1, 2, 3, 4, 5, 12, 19, and 26 of the study. Each session will last 20 minutes.
sham transcranial Direct Current StimulationDevice
Also called Neuromodulation
Patients will undergo repeated sessions of "sham tDCS." The electrodes will be placed over the left DLPFC and the contralateral area, as in the active stimulation condition. However, the current will be delivered only for the first 5 seconds, preventing the participants from detecting the placebo condition while ensuring that no neuromodulation occurs in the underlying brain areas. Patients will undergo a tDCS session on days 1, 2, 3, 4, 5, 12, 19, and 26 of the study. Each session will last 20 minutes.

Study groups in NCT06885138
Study group	Role	What they receive
Sham tDCS	Sham comparator	Patients in this group will receive sham transcranial Direct Current Stimulation (tDCS) Receives: Device: sham transcranial Direct Current Stimulation
Active tDCS	Experimental	Patients in this group will receive active transcranial Direct Current Stimulation (tDCS) (stimulation polarity: anodal). Receives: Device: active transcranial Direct Current Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Beck Depression Inventory-II (BDI-II)
The Beck Depression Inventory-II (BDI-II) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Each item is scored on a scale from 0 to 3, with total scores ranging from 0 to 63. Higher scores indicate more severe depressive symptoms.
Measured: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
Montgomery-Åsberg Depression Rating Scale (MADRS)
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which mental health professionals use to measure the severity of depressive episodes in patients with mood disorders. Each item is rated from 0 to 6, leading to a total score range of 0 to 60. Higher scores indicate more severe depression.
Measured: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) for mood is a widely used tool to assess a person's emotional state. It consists of a straight line, usually 100 mm in length, with one end representing the most negative mood state (e.g., very sad, depressed) and the other end representing the most positive mood state (e.g., very happy, elated). The individual marks a point on the line that corresponds to their current mood, and the distance from the "negative" end to the mark is then measured in millimeters, providing a quantitative measure of the individual's emotional state. Scores range from 0 to 10, with higher scores indicating a more positive mood. This scale is easy to use and provides a subjective yet reliable way to track mood changes over time.
Measured: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)

Secondary outcomes (11)

State-Trait Anxiety Inventory (STAI)
The State-Trait Anxiety Inventory (STAI) is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety. Total scores range from 20 to 80 for each subscale, with higher scores indicating greater anxiety.
Measured: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
Apathy Evaluation Scale (AES)
The Apathy Evaluation Scale (AES) is a 18-item self-report questionnaire assessing apathy in behavioral, cognitive, and emotional domains. Each item is rated on a 4-point Likert scale (1 = not at all, 4 = a lot). Total scores range from 18 to 72, with higher scores indicating greater levels of apathy.
Measured: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
Parkinson's Disease Questionnaire-8 (PDQ-8)
The Parkinson's Disease Questionnaire-8 (PDQ-8) is a self-report measure derived from the PDQ-39. It assesses health-related quality of life in individuals with Parkinson's disease across eight key domains, providing a brief yet effective evaluation of disease impact. It consists of 8 items, each rated on a 5-point Likert scale (0 = never, 4 = always). The total score is transformed to a 0-100 scale, where higher scores indicate worse health-related quality of life.
Measured: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire assessing sleep quality over the past month. It evaluates seven components (e.g., sleep duration, disturbances, latency, and daytime dysfunction), each scored from 0 to 3, yielding a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality
Measured: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
EEG Peak Frequency in the Beta Band (Hz)
The EEG peak frequency in the beta band (13-30 Hz) reflects cortical activity associated with cognitive processing, alertness, arousal, and emotional regulation. Changes in peak beta frequency may indicate alterations in neurophysiological functioning. Higher values are generally linked to increased cortical activation, while lower values may reflect reduced cortical excitability.
Measured: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
Blink Reflex Area (mV·ms)
The blink reflex (BR) area quantifies the overall amplitude of the reflexive eye closure response to external stimuli. It provides information about brainstem excitability and neuromuscular response intensity.
Measured: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
Blink Reflex Duration (ms)
The blink reflex (BR) duration represents the total time from the initiation to the completion of the reflexive eye closure. Prolonged duration may reflect altered neural conduction or motor control.
Measured: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
Blink Reflex Latency (ms)
The blink reflex (BR) latency is the time interval between the stimulus and the onset of the eye closure response. It serves as an indicator of neural transmission efficiency within the trigeminal-facial circuitry.
Measured: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
Startle Saccadic Reflex Area (mV·ms)
The startle saccadic reflex (SSR) area measures the magnitude of the rapid eye movement response to a sudden stimulus, providing insight into sensorimotor integration and brainstem responsiveness.
Measured: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
Startle Saccadic Reflex Duration (ms)
The startle saccadic reflex (SSR) duration refers to the total time span of the reflexive saccadic eye movement. Prolonged duration may reflect changes in neuromuscular coordination and sensorimotor processing.
Measured: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
Startle Saccadic Reflex Latency (ms)
The startle saccadic reflex (SSR) latency is the time interval between the presentation of a sudden stimulus and the initiation of the saccadic eye movement. It provides a measure of neural conduction speed in reflex pathways.
Measured: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Apr 2024Feb 2027

First posted20 Mar 2025
Study start23 Apr 2024
Primary completionFeb 2026 (estimated)
Study completionFeb 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
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: 52 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06885138
Sponsor's protocol ID: 4531
Other IDs: tDCS&PD
Acronym: tDCS&PD
Status last verified: Feb 2025
First submitted: 18 Feb 2025
Last updated: 20 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of the Clinical and Neurophysiological Effects of Transcranial Direct Current Stimulation on Depressive Symptoms in Parkinson's Disease.
ClinicalTrials.gov ID: NCT06885138
Acronym / sponsor ID: tDCS&PD / 4531
Conditions: PARKINSON DISEASE (Disorder)
Keywords: Depression, Parkinson Disease, tDCS
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 52 participants (estimated)
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
Study start: 23 Apr 2024 (actual)
Primary completion: Feb 2026 (estimated)
Study completion: Feb 2027 (estimated)
First posted: 20 Mar 2025 (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.

Objectives

The primary objective of this study is to evaluate the effects of repeated tDCS sessions on depressive symptoms in PD patients. Secondary objectives include:

Assessing the potential impact of repeated tDCS sessions on anxiety, apathy, sleep quality, and quality of life in PD patients.
Investigating the neurophysiological mechanisms underlying depression and the effects induced by tDCS.

Methodology

Eligible patients will be randomly assigned to one of two groups:

Experimental Group: Patients will receive repeated sessions of active tDCS (anodal stimulation). The active electrode (35 cm²) will be placed over the left dorsolateral prefrontal cortex (DLPFC), with the reference electrode (35 cm²) on the contralateral area. Stimulation intensity will be set at 2mA, and each session will last 20 minutes.
Control Group: Patients will receive sham tDCS sessions. Electrodes will be positioned identically to the active condition, but the current will only be applied for the first 5 seconds to prevent perception of the sham condition while ensuring no neuromodulatory effects. Each session will last 20 minutes.

Both groups will undergo tDCS sessions on days 1, 2, 3, 4, 5, 12, 19, and 26 of the study.

T0 (Day 1): Baseline assessment before treatment initiation.
T1 (Day 5): After one week of treatment.
T5 (Day 33): One week after completing all treatment sessions.
T6 (Day 54): One month after treatment completion.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sham tDCS	Sham comparator	Device: sham transcranial Direct Current StimulationPatients in this group will receive sham transcranial Direct Current Stimulation (tDCS)
Active tDCS	Experimental	Device: active transcranial Direct Current StimulationPatients in this group will receive active transcranial Direct Current Stimulation (tDCS) (stimulation polarity: anodal).

Who may qualify

Ages: 35 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Diagnosis of idiopathic Parkinson's disease according to the clinical diagnostic criteria of the Movement Disorder Society;
No dementia (Montreal Cognitive Assessment score ≥ 22/30);
Presence of depressive symptoms
Pharmacological treatment for motor symptoms stable for at least 1 month
Treatment (pharmacological/non-pharmacological) for depressive symptoms stable for at least 3 months.

Key exclusion criteria (9 listed)

Patients with a pacemaker, intracranial electrodes, implanted defibrillators, or any other type of prosthesis;
Patients undergoing Deep Brain Stimulation treatment;
Patients with epilepsy or a history of seizures;
Patients with psychosis;
Patients with a history of skull fracture;

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 transcranial Direct Current StimulationAlso: NeuromodulationPatients will undergo repeated sessions of active transcranial Direct Current Stimulation (tDCS) (anodal polarity). The active electrode (35 cm²) will be placed over the left dorsolateral prefrontal cortex (DLPFC), while the reference electrode (35 cm²) will be positioned over the contralateral area, with a stimulation intensity of 2mA. Patients will undergo a tDCS session on days 1, 2, 3, 4, 5, 12, 19, and 26 of the study. Each session will last 20 minutes.	Device	Active tDCS
sham transcranial Direct Current StimulationAlso: NeuromodulationPatients will undergo repeated sessions of "sham tDCS." The electrodes will be placed over the left DLPFC and the contralateral area, as in the active stimulation condition. However, the current will be delivered only for the first 5 seconds, preventing the participants from detecting the placebo condition while ensuring that no neuromodulation occurs in the underlying brain areas. Patients will undergo a tDCS session on days 1, 2, 3, 4, 5, 12, 19, and 26 of the study. Each session will last 20 minutes.	Device	Sham tDCS

Primary outcome

Beck Depression Inventory-II (BDI-II)
Time frame: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
The Beck Depression Inventory-II (BDI-II) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Each item is scored on a scale from 0 to 3, with total scores ranging from 0 to 63. Higher scores indicate more severe depressive symptoms.
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which mental health professionals use to measure the severity of depressive episodes in patients with mood disorders. Each item is rated from 0 to 6, leading to a total score range of 0 to 60. Higher scores indicate more severe depression.
Visual Analog Scale (VAS)
Time frame: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
The Visual Analog Scale (VAS) for mood is a widely used tool to assess a person's emotional state. It consists of a straight line, usually 100 mm in length, with one end representing the most negative mood state (e.g., very sad, depressed) and the other end representing the most positive mood state (e.g., very happy, elated). The individual marks a point on the line that corresponds to their current mood, and the distance from the "negative" end to the mark is then measured in millimeters, providing a quantitative measure of the individual's emotional state. Scores range from 0 to 10, with higher scores indicating a more positive mood. This scale is easy to use and provides a subjective yet reliable way to track mood changes over time.

11 secondary outcomes

State-Trait Anxiety Inventory (STAI)
Time frame: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
Apathy Evaluation Scale (AES)
Time frame: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
Parkinson's Disease Questionnaire-8 (PDQ-8)
Time frame: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
EEG Peak Frequency in the Beta Band (Hz)
Time frame: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
Blink Reflex Area (mV·ms)
Time frame: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
Blink Reflex Duration (ms)
Time frame: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
Blink Reflex Latency (ms)
Time frame: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
Startle Saccadic Reflex Area (mV·ms)
Time frame: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
Startle Saccadic Reflex Duration (ms)
Time frame: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)
Startle Saccadic Reflex Latency (ms)
Time frame: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)

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 20 Mar 2025.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing active transcranial Direct Current Stimulation in people with PARKINSON DISEASE (Disorder), run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.

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 5 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Beck Depression Inventory-II (BDI-II) (time frame: Baseline (T0); on day 5 (T1); one week after the end of treatment on day 33 (T2); one month after the end of treatment on day 54 (T3)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06885138.

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 20 Mar 2025.