Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07510880

Home tDCS for the Treatment of Major Depression.

Led by Ionclinics & Deionic SL · Updated on 2026-05-01

198

Participants Needed

3

Research Sites

89 weeks

Total Duration

On this page

Sponsors

I

Ionclinics & Deionic SL

Lead Sponsor

H

Hospital Universitari de Bellvitge

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Home tDCS for the Treatment of Major Depression.

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Spanish or Catalan speakers of both sexes between the ages of 18 and 65
  • Diagnosed with major depression or bipolar disorder type 1 or 2 based on DSM-5 criteria
  • Have a moderate or higher score (15 or above) on the Montgomery-5berg Depression Rating Scale (MADRS)
  • May be receiving pharmacological treatment for depression or not
  • Able and willing to commit to supervision and safety monitoring during the study
  • Able to properly apply home tDCS independently or with a companion's help
Not Eligible

You will not qualify if you...

  • Diagnosis of psychotic, schizoaffective, or personality disorders (cluster A and B)
  • History of neurological disease, intellectual disability, or cognitive impairment
  • Presence of metal implants, cochlear implants, pacemakers, brain stimulation in the last 6 months, or clinical/family history of epilepsy
  • Dermatological problems like allergic skin reactions at electrode sites
  • High risk of suicide as assessed by psychiatrist and Columbia Suicide Risk Scale
  • Drug or alcohol abuse in the past 3 months (except nicotine)
  • Changes in pharmacological or non-pharmacological treatments during the study or 3 months prior
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain, 08304

Actively Recruiting

2

Hospital Universitari de Mataró

Mataró, Barcelona, Spain, 08304

Actively Recruiting

3

Parc Taulí Hospital Universitari

Sabadell, Barcelona, Spain, 08208

Not Yet Recruiting

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Research Team

A

Ane Miren Gutiérrez Muto, PhD

CONTACT

E

Ensayos Ionclincs

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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