Major Depression DisorderNCT07510880
Home tDCS for the Treatment of Major Depression.
A study testing Accelerated protocol of home Transcranial direct current stimulation, Conventional protocol of home Transcranial direct current stimulation and Conventional protocol of in person Transcranial direct current stimulation in people with Major Depression Disorder, run by Ionclinics & Deionic SL at 3 sites in Spain.
Trial summary
The purpose of this multicentric randomized controlled trial is to compare the effectiveness and safety of home-based tDCS for the treatment of major depression versus tDCS treatment in a healthcare centre, and explore the effects of an accelerated home-tDCS protocol. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression Disorder
- What is being tested?
- Accelerated protocol of home Transcranial direct current stimulation, Conventional protocol of home Transcranial direct current stimulation and Conventional protocol of in person Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 3 sitesSpain
- Study dates
- 14 Apr 2026to 31 Dec 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spanish or Catalan speakers of both sexes between the ages of 18 and 65.
- Patients diagnosed with major depression, based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Specifically, patients will be included who meet the criteria for a major depressive episode with a longitudinal diagnosis of major depressive disorder, single or recurrent episode; or bipolar disorder type 1 or 2. Patients must obtain a moderate or higher score, therefore we establish a lower limit of 15 points on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Alonzo et al., 2019).
- Patients receiving or not receiving pharmacological treatment for depression will be included, and this will be recorded as an additional variable.
- Have the ability and willingness to commit to the study team for supervision of the intervention sessions and close monitoring of safety.
- Demonstrate the acquisition of the ability to properly apply home tDCS independently or with the help of a companion.
Who cannot join
- Patients with psychotic, schizoaffective, or personality disorders (both cluster A and B).
- Patients with a history of neurological disease, intellectual disability, or cognitive impairment (inability to understand instructions or operate equipment).
- Any exclusion criteria established by clinical guidelines on non-invasive brain stimulation (Woods et al., 2016): metal implants or head injuries, any electronic devices such as cochlear implants or cardiac pacemakers. Brain stimulation in the last 6 months. Clinical or family history of epilepsy.
- Patients with dermatological problems, such as an allergic skin reaction at the electrode site.
- High risk of suicide. Assessed through an interview with a psychiatrist and the use of the Spanish-validated Columbia Suicide Risk Scale (C-SSRS) (Al-Halabí et al., 2016).
- Drug or alcohol abuse during the study or in the previous 3 months (except for nicotine).
- Changes in pharmacological or non-pharmacological treatment (such as structured psychotherapy) during the study or in the 3 months prior to starting the trial.
- Pregnancy.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08304
Ionclinics, +34674059324, ensayos@ionclinics.com
- Recruiting
Hospital Universitari de Mataró
Mataró, Barcelona, 08304
Ionclinics, +34674059324, ensayos@ionclinics.com
- Not yet recruiting
Parc Taulí Hospital Universitari
Sabadell, Barcelona, 08208
Ionclinics, +34674059324, ensayos@ionclinics.com
About this study
Official title: Home tDCS for the Treatment of Major Depression: A Randomised Clinical Trial
The purpose of this multicentric randomized controlled trial is to compare the effectiveness and safety of home-based tDCS for the treatment of major depression versus tDCS treatment in a healthcare centre, and explore the effects of an accelerated home-tDCS protocol.
The change in depression index at the end of treatment, measured with MADRS, will be the primary outcome.
- Conditions
- Major Depression Disorder
- Being tested
- Accelerated protocol of home Transcranial direct current stimulation, Conventional protocol of home Transcranial direct current stimulation, Conventional protocol of in person Transcranial direct current stimulation
- Keywords
- Major Depression, Electric Stimulation Therapy, Transcranial Direct Current Stimulation
- 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.
Accelerated protocol of home Transcranial direct current stimulationDevice
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique in which a weak direct current (2 mA) is applied to the scalp via electrodes. The anode will be applied to F3 (the dorsolateral prefrontal cortex) and the cathode to F8 (the contralateral frontotemporal region). The application of tDCS will be carried out at home in this group. Each session will consist of 20 minutes of stimulation. Dose: 3 weeks, daily. (1) 1st week - 3 times per day; (2) 2nd Week - 2 times per day; (3) 3rd week - 1 time per day (total of 42 sessions).
Conventional protocol of home Transcranial direct current stimulationDevice
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique in which a weak direct current (2 mA) is applied to the scalp via electrodes. The anode will be applied to F3 (the dorsolateral prefrontal cortex) and the cathode to F8 (the contralateral frontotemporal region). The application of tDCS will be carried out at home in this group. Each session will consist of 20 minutes of stimulation. Dose: 9 weeks, from Monday to Friday. 1 time per day (total of 42 sessions).
Conventional protocol of in person Transcranial direct current stimulationDevice
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique in which a weak direct current (2 mA) is applied to the scalp via electrodes. The anode will be applied to F3 (the dorsolateral prefrontal cortex) and the cathode to F8 (the contralateral frontotemporal region). The application of tDCS will be carried out at the medical facilities. Each session will consist of 20 minutes of stimulation. Dose: 9 weeks, from Monday to Friday. 1 time per day (total of 42 sessions).
| Study group | Role | What they receive |
|---|---|---|
| Accelerated home tDCS | Experimental | Home tDCS applied over 3 weeks (42 sessions) Receives: Device: Accelerated protocol of home Transcranial direct current stimulation |
| Conventional home tDCS | Active comparator | Home tDCS applied over 9 weeks (42 sessions) Receives: Device: Conventional protocol of in person Transcranial direct current stimulation |
| Conventional ambulatory tDCS | Active comparator | Ambulatory tDCS applied over 9 weeks (42 sessions) Receives: Device: Conventional protocol of home Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS
Mean score change based on Montgomery-Asberg Depression Rating Scale (MADRS) of the three arms at the end of the treatment compared to baseline.
Measured: End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.
Secondary outcomes (14)
MADRS
Mean score change based on Montgomery-Asberg Depression Rating Scale (MADRS) of the three arms at the end of the second week of treatment compared to baseline.
Measured: 2nd week of treatment.
MADRS
Mean score change based on Montgomery-Asberg Depression Rating Scale (MADRS) of the three arms at 3 months post-treatment compared to baseline.
Measured: 3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.
HDRS-17
Mean score change based on Hamilton Depression Rating Scale (HDRS) of the three arms at the end of the treatment compared to baseline.
Measured: End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.
HDRS-17
Mean score change based on Hamilton Depression Rating Scale (HDRS-17) of the three arms at the end of the second week of treatment compared to baseline.
Measured: 2nd week of treatment.
HDRS-17
Mean score change based on Hamilton Depression Rating Scale (HDRS-17) scores of the three arms at 3 months compared to baseline compared to baseline.
Measured: 3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.
HARS
Mean score change based on Hamilton Anxiety Rating Scale (HARS) of the three arms at the end of the treatment compared to baseline.
Measured: End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.
HARS
Mean score change based on Hamilton Anxiety Rating Scale (HARS) of the three arms at the end of the second week of treatment compared to baseline.
Measured: 2nd week of treatment.
HARS
Mean score change based on Hamilton Anxiety Rating Scale (HARS) scores of the three arms at 3 months compared to baseline compared to baseline.
Measured: 3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.
PHQ9
Mean score change based on Patient Health Questionnaire-9 (PHQ9) of the three arms at the end of the treatment compared to baseline.
Measured: End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.
PHQ9
Mean score change based on Patient Health Questionnaire-9 (PHQ9) of the three arms at the end of the second week of treatment compared to baseline.
Measured: 2nd week of treatment.
PHQ9
Mean score change based on Patient Health Questionnaire-9 (PHQ9) scores of the three arms at 3 months compared to baseline compared to baseline.
Measured: 3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.
Clinical Global Impression
Score based on Clinical Global Impression of the three arms at the end of the treatment.
Measured: End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.
Clinical Global Impression
Score based on Clinical Global Impression of the three arms at the end of the second week of treatment.
Measured: 2nd week of treatment.
Clinical Global Impression
Score based on Clinical Global Impression of the three arms at 3 months compared to baseline.
Measured: 3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start14 Apr 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depression DisorderStudies 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
- Model description
- Randomized, parallel, double-blind, multicentre clinical trial. Recruited subjects will be randomised into three groups: conventional tDCS at a healthcare centre (control intervention), conventional tDCS at home, and accelerated tDCS at home (allocation ratio of 1:1:1).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ionclinics & Deionic SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitari de Bellvitge, Consorci Sanitari del Maresme. Hospital Universitari de Mataró, Parc Taulí Hospital Universitari
- Responsible party
- Sponsor
- Investigators
- Ane Miren Gutiérrez Muto, Study director, Ionclinics & Deionics S.L.Mar Hernández Secorún, Study chair, Ionclinics & Deionics S.L.Gustavo Sarriá Córdoba, Study chair, Ionclinics & Deionics S.L.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510880
- Sponsor's protocol ID
- PI_2025_05_14_V4
- Status last verified
- Apr 2026
- First submitted
- 6 Mar 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In accordance with the recommendations of the International Committee of Medical Journal Editors, the de-identified individual participant data (IPD) that underlie the results reported in this study will be shared. The data will become accessible one year after the publication of the primary results and will remain available for five years. Access will be provided to researchers who inquire and agree to a data-use agreement through Ionclinics (investigacion@ionclinics.com/ensayos@ionclinics.com). The data will be de-identified and shared in accordance with applicable regulations and the informed consent provided by the participants.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home tDCS for the Treatment of Major Depression: A Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT07510880
- Acronym / sponsor ID
- PI_2025_05_14_V4
- Conditions
- Major Depression Disorder
- Keywords
- Major Depression, Electric Stimulation Therapy, Transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Ionclinics & Deionic SLIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Universitari de Bellvitge, Consorci Sanitari del Maresme. Hospital Universitari de Mataró, Parc Taulí Hospital Universitari
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Apr 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.
The purpose of this multicentric randomized controlled trial is to compare the effectiveness and safety of home-based tDCS for the treatment of major depression versus tDCS treatment in a healthcare centre, and explore the effects of an accelerated home-tDCS protocol.
The change in depression index at the end of treatment, measured with MADRS, will be the primary outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, parallel, double-blind, multicentre clinical trial. Recruited subjects will be randomised into three groups: conventional tDCS at a healthcare centre (control intervention), conventional tDCS at home, and accelerated tDCS at home (allocation ratio of 1:1:1).
| Arm | Type | Receives |
|---|---|---|
| Accelerated home tDCS | Experimental | Device: Accelerated protocol of home Transcranial direct current stimulationHome tDCS applied over 3 weeks (42 sessions) |
| Conventional home tDCS | Active comparator | Device: Conventional protocol of in person Transcranial direct current stimulationHome tDCS applied over 9 weeks (42 sessions) |
| Conventional ambulatory tDCS | Active comparator | Device: Conventional protocol of home Transcranial direct current stimulationAmbulatory tDCS applied over 9 weeks (42 sessions) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Spanish or Catalan speakers of both sexes between the ages of 18 and 65.
- Patients diagnosed with major depression, based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Specifically, patients will be included who meet the criteria for a major depressive episode with a longitudinal diagnosis of major depressive disorder, single or recurrent episode; or bipolar disorder type 1 or 2. Patients must obtain a moderate or higher score, therefore we establish a lower limit of 15 points on the Montgomery-Åsberg Depression Rating Scale (MADRS) (Alonzo et al., 2019).
- Patients receiving or not receiving pharmacological treatment for depression will be included, and this will be recorded as an additional variable.
- Have the ability and willingness to commit to the study team for supervision of the intervention sessions and close monitoring of safety.
- Demonstrate the acquisition of the ability to properly apply home tDCS independently or with the help of a companion.
Key exclusion criteria (8 listed)
- Patients with psychotic, schizoaffective, or personality disorders (both cluster A and B).
- Patients with a history of neurological disease, intellectual disability, or cognitive impairment (inability to understand instructions or operate equipment).
- Any exclusion criteria established by clinical guidelines on non-invasive brain stimulation (Woods et al., 2016): metal implants or head injuries, any electronic devices such as cochlear implants or cardiac pacemakers. Brain stimulation in the last 6 months. Clinical or family history of epilepsy.
- Patients with dermatological problems, such as an allergic skin reaction at the electrode site.
- High risk of suicide. Assessed through an interview with a psychiatrist and the use of the Spanish-validated Columbia Suicide Risk Scale (C-SSRS) (Al-Halabí et al., 2016).
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 |
|---|---|---|
| Accelerated protocol of home Transcranial direct current stimulationTranscranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique in which a weak direct current (2 mA) is applied to the scalp via electrodes. The anode will be applied to F3 (the dorsolateral prefrontal cortex) and the cathode to F8 (the contralateral frontotemporal region). The application of tDCS will be carried out at home in this group. Each session will consist of 20 minutes of stimulation. Dose: 3 weeks, daily. (1) 1st week - 3 times per day; (2) 2nd Week - 2 times per day; (3) 3rd week - 1 time per day (total of 42 sessions). | Device | Accelerated home tDCS |
| Conventional protocol of home Transcranial direct current stimulationTranscranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique in which a weak direct current (2 mA) is applied to the scalp via electrodes. The anode will be applied to F3 (the dorsolateral prefrontal cortex) and the cathode to F8 (the contralateral frontotemporal region). The application of tDCS will be carried out at home in this group. Each session will consist of 20 minutes of stimulation. Dose: 9 weeks, from Monday to Friday. 1 time per day (total of 42 sessions). | Device | Conventional ambulatory tDCS |
| Conventional protocol of in person Transcranial direct current stimulationTranscranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique in which a weak direct current (2 mA) is applied to the scalp via electrodes. The anode will be applied to F3 (the dorsolateral prefrontal cortex) and the cathode to F8 (the contralateral frontotemporal region). The application of tDCS will be carried out at the medical facilities. Each session will consist of 20 minutes of stimulation. Dose: 9 weeks, from Monday to Friday. 1 time per day (total of 42 sessions). | Device | Conventional home tDCS |
Primary outcome
MADRS
Time frame: End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.
Mean score change based on Montgomery-Asberg Depression Rating Scale (MADRS) of the three arms at the end of the treatment compared to baseline.
14 secondary outcomes
MADRS
Time frame: 2nd week of treatment.
MADRS
Time frame: 3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.
HDRS-17
Time frame: End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.
HDRS-17
Time frame: 2nd week of treatment.
HDRS-17
Time frame: 3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.
HARS
Time frame: End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.
HARS
Time frame: 2nd week of treatment.
HARS
Time frame: 3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.
PHQ9
Time frame: End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.
PHQ9
Time frame: 2nd week of treatment.
PHQ9
Time frame: 3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.
Clinical Global Impression
Time frame: End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.
Clinical Global Impression
Time frame: 2nd week of treatment.
Clinical Global Impression
Time frame: 3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.
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 1 May 2026.
- Individual participant dataSharing planned: No. In accordance with the recommendations of the International Committee of Medical Journal Editors, the de-identified individual participant data (IPD) that underlie the results reported in this study will be shared. The data will become accessible one year after the publication of the primary results and will remain available for five years. Access will be provided to researchers who inquire and agree to a data-use agreement through Ionclinics (investigacion@ionclinics.com/ensayos@ionclinics.com). The data will be de-identified and shared in accordance with applicable regulations and the informed consent provided by the participants.
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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.
Ane Miren Gutiérrez Muto study director
Ionclinics & Deionics S.L.
Mar Hernández Secorún study chair
Ionclinics & Deionics S.L.
Gustavo Sarriá Córdoba study chair
Ionclinics & Deionics S.L.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated protocol of home Transcranial direct current stimulation, Conventional protocol of home Transcranial direct current stimulation and Conventional protocol of in person Transcranial direct current stimulation in people with Major Depression Disorder, run by Ionclinics & Deionic SL at 3 sites in Spain.
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 8 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 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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 Ane Miren Gutiérrez Muto, PhD (+34960606200, investigacion@ionclinics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MADRS (time frame: End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm.). 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 1 May 2026.