DepressionCAPUCINOONCT07490379
Comparison of the Efficacy of Transcranial Direct Current Stimulation at Home Versus in Hospital Settings in Patients With Depressive Episodes
A study testing Distribution of study questionnaires, tDCS sessions (D1-D10) and Monitoring tDCS appropriation in people with Depression, run by Nantes University Hospital at 6 sites in France.
Trial summary
Transcranial direct current stimulation (tDCS) is a neuromodulation method that modulates brain activity using low-intensity electrical current. Used in the treatment of depression, it is easily adaptable for both caregivers and patients, with good tolerance, under appropriate supervision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Distribution of study questionnaires, tDCS sessions (D1-D10) and Monitoring tDCS appropriation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 6 sitesFrance
- Study dates
- 31 Jul 2026to 31 Mar 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women over the age of 18
- Psychiatric diagnosis:
- Presenting a depressive episode characterised according to DSM-5 criteria
- MADRS score greater than or equal to 20, indicating moderate to severe depression
- Indication and prescription of a course of tDCS treatment consisting of 20 sessions of 30 minutes at 2mA, at a rate of 2 sessions per day
- Drug treatment:
Show all 13Show fewer
- o Failure of a maximum of 1 or 2 antidepressants taken successively or in combination for the current episode
- Psychiatric follow-up: Receiving medical follow-up by a psychiatrist or referring physician
- Ability to understand and cooperate:
- Having a smartphone, computer or tablet (with internet connection and Bluetooth) to use the digital interface required to perform remote tDCS
- Be deemed capable of understanding the nature of the study and participating in clinical follow-up
- Informed consent: Have given written consent to participate in the research, after receiving oral and written information about the study.
- Social affiliation: Be affiliated with a social security system
Who cannot join
- Psychiatric or neurological diagnoses:
- Chronic psychotic disorders or history of schizophrenia
- Progressive neurological disorders (unstabilised epilepsy, brain tumour, recent stroke, severe head injury)
- History or current treatment of neuromodulation
- Any history of tDCS treatment, whether carried out in a clinical or research setting
- Current treatment or history of rTMS and ECT sessions for the current episode
Show all 27Show fewer
- Presence of an active vagus nerve stimulation implant
- Presence of a high risk of suicide. A risk of suicide will be considered high if the score on item 10 of the MADRS scale ("Suicidal Thoughts") is 4 or higher, and/or if there is active suicidal ideation accompanied by clinically identified intent or a plan
- Addiction and substance use: Current substance use disorder other than nicotine or caffeine
- Psychiatric comorbidities that may interfere with study participation, including: understanding information, adherence to the protocol, and completing CBT sessions.
- Recent change in curative psychotropic treatment (antidepressant, mood stabiliser including lithium and anticonvulsants, mood-stabilising antipsychotic) in the month prior to inclusion.
- Medical contraindication to stimulation:
- Presence of a metallic or electronic implant in the skull or chest (pacemaker, neurostimulator, cochlear implant)
- Skin lesion, irritation or wound on the electrode contact areas
- History of epileptic seizures not related to an identified cause or not stabilised for more than 12 months
- Current pregnancy or breastfeeding
- Women of childbearing age without effective contraception (hormonal or medical device)
- A severe and/or progressive somatic condition requiring ongoing medical care that would interfere with participation in the study.
- Limited ability to participate:
- A significant cognitive impairment or sensory deficit that prevents understanding of instructions
- Inability to safely perform tDCS at home, as defined by at least one of the following:
- inability to understand or recall essential instructions regarding procedure and safety;
- inability to perform, following initial guidance, the essential steps for setting up and starting the device;
- lack of the minimum material conditions required at home to conduct the sessions.
- Special legal or social situation:
- Patients under guardianship, curatorship or judicial protection
- Privation of liberty by judicial or administrative decision, Presence of a functional limitation to the independent performance of tDCS
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Not yet recruiting
Clinique Mirambeau
Anglet
Christophe DAUDET, +33 5 59 52 33 00, cdaudet001@gmail.com
Christophe DAUDET
- Not yet recruiting
CH Georges Mazurelle
La Roche-sur-Yon
Cathy LONGUECHAUD, +33 2 51 09 72 72, Cathy.longuechaud@ch-mazurelle.fr
Cathy LONGUECHAUD
- Recruiting
CHU de Nantes
Nantes
Damiens CHONEAU, +33 2 44 76 83 70, damiens.choneau@chu-nantes.fr
Damiens CHONEAU
- Not yet recruiting
CHU de Nîmes
Nîmes
Antoine GIRON, +33 6 29 84 30 73, antoine.giron@chu-nimes.fr
Antoine GIRON
- Not yet recruiting
CH Le Rouvray
Sotteville-lès-Rouen
Marie-Laure MILLET, +33 2 32 95 68 25, Marie-Laure.MILLET@ch-lerouvray.fr
Marie-Laure MILLET
- Not yet recruiting
CH Léon-Jean Grégory - Thuir
Thuir
Philippe RAYNAUD DE PRIGNY, +33 4 68 84 66 10, Philippe.Raynaud@ch-thuir.fr
Philippe RAYNAUD DE PRIGNY
About this study
Official title: CAPUCINOO - Comparison of the Efficacy of Transcranial Direct Current Stimulation at Home Versus in Hospital Settings in Patients With Depressive Episodes: Non-inferiority Study, the Impact of Nursing Follow-up and Implementation of the Care Pathway
Transcranial direct current stimulation (tDCS) is a neuromodulation method that modulates brain activity using low-intensity electrical current. Used in the treatment of depression, it is easily adaptable for both caregivers and patients, with good tolerance, under appropriate supervision.
Allowing patients to perform tDCS at home could address issues of access to care (distance from home, overall cost of care, lack of healthcare professionals, difficulty travelling for physical/psychological reasons, etc.). Studies on tDCS have highlighted the importance of regular clinical monitoring to ensure compliance and safety, which are essential factors for therapeutic efficacy.
The main objective of this study is to demonstrate the non-inferiority of tDCS performed at home versus in hospital in terms of effectiveness in reducing depressive symptoms at 6 weeks post-treatment in patients with moderate to severe depression.
- Conditions
- Depression
- Being tested
- Distribution of study questionnaires, tDCS sessions (D1-D10), Monitoring tDCS appropriation, Semi-structured interviews with patients
- Keywords
- Depression, Direct transcranial direct current stimulation, Nursing follow-up, Implementation, Care pathway
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distribution of study questionnairesOther
The questionnaires will be administered to patients at DO, D10, and M2. MADRS/RSES/EQ-5D-5L/BDI/CRQ
tDCS sessions (D1-D10)Other
Protocol: 2 mA, 30 min, 10 working days (Monday to Friday), 2 sessions/day
Monitoring tDCS appropriationOther
During visits to the hospital, the nurse ensures that the patient knows how to use the device correctly.
Semi-structured interviews with patientsOther
The interviews will be conducted by telephone with patients participating in the study. The purpose of these interviews is to gather information for the qualitative aspect of the implementation.
| Study group | Role | What they receive |
|---|---|---|
| tDCS at the hospital | Active comparator | In the control group, patients receive tDCS treatment at the hospital under nursing supervision. In the control group, patients receive tDCS treatment at the hospital under nursing supervision. Receives: Other: Distribution of study questionnaires; Other: tDCS sessions (D1-D10); Other: Semi-structured interviews with patients |
| Performing tDCS at home | Experimental | As part of the home intervention group, patients undergo a self-administered tDCS treatment, but under remote nursing supervision via the SoomaDuo app (CE marked, used in accordance with the tDCS device). This device allows daily monitoring of treatment, automatic verification of stimulation parameters and complete traceability of compliance. Receives: Other: Distribution of study questionnaires; Other: tDCS sessions (D1-D10); Other: Monitoring tDCS appropriation; Other: Semi-structured interviews with patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the non-inferiority of tDCS administered at home compared to in-hospital treatment in terms of effectiveness in reducing depressive symptoms 6 weeks post-treatment, using the MADRS (Montgomery-Asberg Depression Rating Scale).
The scale ranges from 0 to 60, with 60 representing the worst possible outcome.
Measured: 2 months
Secondary outcomes (16)
Evaluate the response to treatment by comparing the two arms immediately post-treatment and at M2 (6 weeks post-treatment). This will be assessed by the change in the total MADRS scale score.
The scale ranges from 0 to 60, with 60 representing the worst possible outcome.
Measured: 2 Months
Evaluate the remission rate in each of the two arms immediately after treatment and at M2.
Measured: 2 months
Compare the change in patient self-reported depressive symptoms using the BDI-II (Beck Depression Inventory-II) in both study arms, measured immediately post-treatment and at M2 (6 weeks post-treatment).
The scale ranges from 0 to 3, where 3 representing the worst possible outcome.
Measured: 2 months
Assess the impact of tDCS on self-esteem using the Rosenberg Self-Esteem Scale (RSES) in both study arms, measured immediately post-treatment and at M2 (6 weeks post-treatment).
The scale ranges from 1 to 4, where 1 indicates "strongly disagree" and 4 indicates "strongly agree.
Measured: 2 months
Study patients' quality of life using the EQ-5D-5L after tDCS treatment in each of the two arms immediately after treatment and at M2.
The scale ranges from 0 to 100, with 0 representing the worst possible outcome.
Measured: 2 months
Assess the safety of the two tDCS administration modalities using the Comfort Rating Questionnaire (CRQ) in each of the two arms immediately after treatment.
The scale ranges from 0 to 10, with 10 representing the worst possible outcome.
Measured: 10 Days
Compare efficiency from a collective perspective and over a two-month time horizon.
Incremental cost-utility ratio (cost per QALY) at 2 months.
Measured: 2 months
Analyse the financial impact of the rollout of tDCS at home (budget impact analysis over 5 years)
Measured: 2 months
Determine the optimal implementation conditions for the effective deployment of tDCS at home across the following domain : Relevance
Qualitative analysis of data collected during semi-structured interviews with patients and their relatives regarding the suitability or unsuitability of the method of administering tDCS at home.
Measured: 2 months
Determine the optimal implementation conditions for the effective deployment of tDCS at home across the following domain : Acceptability
- Proportion of reasons for refusal among patients identified but not included following a log-based screening process, linked to a negative perception of tDCS.
- Number of patients reporting discomfort during stimulation
- Number of patients who withdrew after randomisation due to a negative experience of tDCS.
Measured: 2 months
Determine the optimal implementation conditions for the effective deployment of tDCS at home across the following domain : Fidelity
Ratio of the number of sessions completed to the number of sessions planned in each of the two groups. // Proportion of patients who discontinued the protocol before completion // Factors leading to deviations that resulted in the treatment being carried out over a longer period or in the tDCS stimulation treatment being discontinued.
Measured: 2 months
Determine the optimal implementation conditions for the effective deployment of tDCS at home across the following domain : Adoption
Proportion of individuals included among those identified. Description of the reasons for excluding patients who were identified but not included. Frequency of inclusions.
Measured: 2 months
Determine the optimal implementation conditions for the effective deployment of tDCS at home across the following domain : Implementation Costs (microcosting).
Measured: 2 months
Determine the optimal implementation conditions for the effective deployment of tDCS at home across the following domain : Feasibility
Number of patients who completed the full course of tDCS treatment.
Measured: 2 months
Determine the optimal implementation conditions for the effective deployment of tDCS at home across the following domain: Reach (Sociodemographic profile of the patients included)
Measured: 2 months
Determine the optimal implementation conditions for the effective deployment of tDCS at home across the following domain : Sustainability (Integration of the scheme into the facility's care programme)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start31 Jul 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins, Sooma Medical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490379
- Sponsor's protocol ID
- RC25_0344
- Other IDs
- 2026-A00335-46
- Acronym
- CAPUCINOO
- Status last verified
- Aug 2026
- First submitted
- 11 Mar 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAPUCINOO - Comparison of the Efficacy of Transcranial Direct Current Stimulation at Home Versus in Hospital Settings in Patients With Depressive Episodes: Non-inferiority Study, the Impact of Nursing Follow-up and Implementation of the Care Pathway
- ClinicalTrials.gov ID
- NCT07490379
- Acronym / sponsor ID
- CAPUCINOO / RC25_0344
- Conditions
- Depression
- Keywords
- Depression, Direct transcranial direct current stimulation, Nursing follow-up, Implementation, Care pathway
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins, Sooma Medical
- Study start
- 31 Jul 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 24 Mar 2026 (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.
Transcranial direct current stimulation (tDCS) is a neuromodulation method that modulates brain activity using low-intensity electrical current. Used in the treatment of depression, it is easily adaptable for both caregivers and patients, with good tolerance, under appropriate supervision.
Allowing patients to perform tDCS at home could address issues of access to care (distance from home, overall cost of care, lack of healthcare professionals, difficulty travelling for physical/psychological reasons, etc.). Studies on tDCS have highlighted the importance of regular clinical monitoring to ensure compliance and safety, which are essential factors for therapeutic efficacy.
The main objective of this study is to demonstrate the non-inferiority of tDCS performed at home versus in hospital in terms of effectiveness in reducing depressive symptoms at 6 weeks post-treatment in patients with moderate to severe depression.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS at the hospital | Active comparator | Other: Distribution of study questionnaires, Other: tDCS sessions (D1-D10), Other: Semi-structured interviews with patientsIn the control group, patients receive tDCS treatment at the hospital under nursing supervision. In the control group, patients receive tDCS treatment at the hospital under nursing supervision. |
| Performing tDCS at home | Experimental | Other: Distribution of study questionnaires, Other: tDCS sessions (D1-D10), Other: Monitoring tDCS appropriation, Other: Semi-structured interviews with patientsAs part of the home intervention group, patients undergo a self-administered tDCS treatment, but under remote nursing supervision via the SoomaDuo app (CE marked, used in accordance with the tDCS device). This device allows daily monitoring of treatment, automatic verification of stimulation parameters and complete traceability of compliance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Men or women over the age of 18
- Psychiatric diagnosis:
- Drug treatment:
- o Failure of a maximum of 1 or 2 antidepressants taken successively or in combination for the current episode
- Psychiatric follow-up: Receiving medical follow-up by a psychiatrist or referring physician
Key exclusion criteria (27 listed)
- Psychiatric or neurological diagnoses:
- History or current treatment of neuromodulation
- Presence of a high risk of suicide. A risk of suicide will be considered high if the score on item 10 of the MADRS scale ("Suicidal Thoughts") is 4 or higher, and/or if there is active suicidal ideation accompanied by clinically identified intent or a plan
- Addiction and substance use: Current substance use disorder other than nicotine or caffeine
- Psychiatric comorbidities that may interfere with study participation, including: understanding information, adherence to the protocol, and completing CBT sessions.
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 |
|---|---|---|
| Distribution of study questionnairesThe questionnaires will be administered to patients at DO, D10, and M2. MADRS/RSES/EQ-5D-5L/BDI/CRQ | Other | Performing tDCS at home, tDCS at the hospital |
| tDCS sessions (D1-D10)Protocol: 2 mA, 30 min, 10 working days (Monday to Friday), 2 sessions/day | Other | Performing tDCS at home, tDCS at the hospital |
| Monitoring tDCS appropriationDuring visits to the hospital, the nurse ensures that the patient knows how to use the device correctly. | Other | Performing tDCS at home |
| Semi-structured interviews with patientsThe interviews will be conducted by telephone with patients participating in the study. The purpose of these interviews is to gather information for the qualitative aspect of the implementation. | Other | Performing tDCS at home, tDCS at the hospital |
Primary outcome
Evaluate the non-inferiority of tDCS administered at home compared to in-hospital treatment in terms of effectiveness in reducing depressive symptoms 6 weeks post-treatment, using the MADRS (Montgomery-Asberg Depression Rating Scale).
Time frame: 2 months
The scale ranges from 0 to 60, with 60 representing the worst possible outcome.
16 secondary outcomes
Evaluate the response to treatment by comparing the two arms immediately post-treatment and at M2 (6 weeks post-treatment). This will be assessed by the change in the total MADRS scale score.
Time frame: 2 Months
Evaluate the remission rate in each of the two arms immediately after treatment and at M2.
Time frame: 2 months
Compare the change in patient self-reported depressive symptoms using the BDI-II (Beck Depression Inventory-II) in both study arms, measured immediately post-treatment and at M2 (6 weeks post-treatment).
Time frame: 2 months
Assess the impact of tDCS on self-esteem using the Rosenberg Self-Esteem Scale (RSES) in both study arms, measured immediately post-treatment and at M2 (6 weeks post-treatment).
Time frame: 2 months
Study patients' quality of life using the EQ-5D-5L after tDCS treatment in each of the two arms immediately after treatment and at M2.
Time frame: 2 months
Assess the safety of the two tDCS administration modalities using the Comfort Rating Questionnaire (CRQ) in each of the two arms immediately after treatment.
Time frame: 10 Days
Compare efficiency from a collective perspective and over a two-month time horizon.
Time frame: 2 months
Analyse the financial impact of the rollout of tDCS at home (budget impact analysis over 5 years)
Time frame: 2 months
Determine the optimal implementation conditions for the effective deployment of tDCS at home across the following domain : Relevance
Time frame: 2 months
Determine the optimal implementation conditions for the effective deployment of tDCS at home across the following domain : Acceptability
Time frame: 2 months
Determine the optimal implementation conditions for the effective deployment of tDCS at home across the following domain : Fidelity
Time frame: 2 months
Determine the optimal implementation conditions for the effective deployment of tDCS at home across the following domain : Adoption
Time frame: 2 months
Determine the optimal implementation conditions for the effective deployment of tDCS at home across the following domain : Implementation Costs (microcosting).
Time frame: 2 months
Determine the optimal implementation conditions for the effective deployment of tDCS at home across the following domain : Feasibility
Time frame: 2 months
Determine the optimal implementation conditions for the effective deployment of tDCS at home across the following domain: Reach (Sociodemographic profile of the patients included)
Time frame: 2 months
Determine the optimal implementation conditions for the effective deployment of tDCS at home across the following domain : Sustainability (Integration of the scheme into the facility's care programme)
Time frame: 2 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 31 Aug 2026.
- 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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distribution of study questionnaires, tDCS sessions (D1-D10) and Monitoring tDCS appropriation in people with Depression, run by Nantes University Hospital at 6 sites in France.
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 13 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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. 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 Damiens Choneau (02 53 48 28 35 ext. +33, bp-prom-regl@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the non-inferiority of tDCS administered at home compared to in-hospital treatment in terms of effectiveness in reducing depressive symptoms 6 weeks post-treatment, using the MADRS (Montgomery-Asberg Depression Rating Scale). (time frame: 2 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 31 Aug 2026.