Home transcranial direct current stimulation for major depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized controlled trial compares home‑based tDCS (with both an accelerated home protocol and a conventional home protocol) to conventional in‑person tDCS delivered at a healthcare center. Adults with a current major depressive episode (including unipolar major depressive disorder or bipolar disorder type 1 or 2) and a MADRS score of 15 or higher are eligible, whether or not they are taking antidepressant medication. Participants must learn to self‑apply the device and agree to supervised sessions and close safety monitoring. The primary outcome is change in MADRS score at the end of treatment, with safety and tolerability recorded throughout.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitario de Bellvitge
  L'Hospitalet de Llobregat, Barcelona, Spain Recruiting
• Hospital Universitari de Mataró
  Mataró, Barcelona, Spain Recruiting
• Parc Taulí Hospital Universitari
  Sabadell, Barcelona, Spain Not yet recruiting

Study contacts

• Study coordinator: Ane Miren Gutiérrez Muto, PhD
• Email: investigacion@ionclinics.com
• Phone: +34960606200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.