Home tDCS for the Treatment of Major Depression.

Recruiting now · Not applicable

Conditions studied: Major Depression Disorder

In brief

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.

Key facts

Study ID

NCT07510880

Run by

Ionclinics & Deionic SL

People needed

198

Starts

2026-04-14

Expected to finish

2027-12-31

Last updated by the study team

2026-05-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hospital Universitario de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain (enrolling)
• Hospital Universitari de Mataró — Mataró, Barcelona, Spain (enrolling)
• Parc Taulí Hospital Universitari — Sabadell, Barcelona, Spain

Full record on ClinicalTrials.gov

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