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NCT Number: NCT07510880

Home tDCS for the Treatment of Major Depression.

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Accelerated protocol of home Transcranial direct current stimulation

Device

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 stimulation

Device

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 stimulation

Device

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. MADRS

    Time frame: 2nd week of treatment.

    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.

  2. MADRS

    Time frame: 3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 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 3 months post-treatment compared to baseline.

  3. HDRS-17

    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 Hamilton Depression Rating Scale (HDRS) of the three arms at the end of the treatment compared to baseline.

  4. HDRS-17

    Time frame: 2nd week of treatment.

    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.

  5. 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.

    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.

  6. HARS

    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 Hamilton Anxiety Rating Scale (HARS) of the three arms at the end of the treatment compared to baseline.

  7. HARS

    Time frame: 2nd week of treatment.

    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.

  8. HARS

    Time frame: 3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.

    Mean score change based on Hamilton Anxiety Rating Scale (HARS) scores of the three arms at 3 months compared to baseline compared to baseline.

  9. PHQ9

    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 Patient Health Questionnaire-9 (PHQ9) of the three arms at the end of the treatment compared to baseline.

  10. PHQ9

    Time frame: 2nd week of treatment.

    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.

  11. PHQ9

    Time frame: 3 months follow-up: 15 week for Accelerated home-tDCS arm; 21 week for Conventional home-tDCS and ambulatory tDCS arm.

    Mean score change based on Patient Health Questionnaire-9 (PHQ9) scores of the three arms at 3 months compared to baseline compared to baseline.

  12. 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.

    Score based on Clinical Global Impression of the three arms at the end of the treatment.

  13. Clinical Global Impression

    Time frame: 2nd week of treatment.

    Score based on Clinical Global Impression of the three arms at the end of the second week of treatment.

  14. 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.

    Score based on Clinical Global Impression of the three arms at 3 months compared to baseline.

Other outcomes

  1. Patient Expectations

    Time frame: Baseline

    Likert scale from 1 to 5 (where 1 is no expectation and 5 is the highest possible expectation) to study the influence of expectation on the effect of treatment.

  2. Adverse Effect

    Time frame: End-of-day application (Experimental: from Monday to Sunday through 3 weeks; Active Comparator: From Monday to Friday, through 9 weeks).

    A daily questionnaire about adverse effects will be completed at the end of the last intervention of the day.

  3. Success of the blinding

    Time frame: Through study completion, an average of 2 years

    A method 2 x 3 will be used to evaluate the success of the study's evaluator and statistician.

Study contacts

Contact information is provided by the study sponsor or research team.

Ane Miren Gutiérrez Muto, PhD

CONTACT

[email protected]

+34960606200

Ensayos Ionclincs

CONTACT

[email protected]

+34674059324

Sponsors and collaborators

Lead sponsor

Ionclinics & Deionic SL

Industry

Collaborators

  • Consorci Sanitari del Maresme. Hospital Universitari de Mataró
  • Hospital Universitari de Bellvitge
  • Parc Taulí Hospital Universitari

Registry information

Official study title

Home tDCS for the Treatment of Major Depression: A Randomised Clinical Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 6, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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