Major Depression Clinical Trials

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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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. The change in depression index at the end of treatment, measured with MADRS, will be the primary outcome.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Universitario de Bellvitge
RECRUITING
L'hospitalet De Llobregat
Hospital Universitari de Mataró
RECRUITING
Mataró
Parc Taulí Hospital Universitari
NOT_YET_RECRUITING
Sabadell
Contact Information
Primary
Ane Miren Gutiérrez Muto, PhD
investigacion@ionclinics.com
+34960606200
Backup
Ensayos Ionclincs
ensayos@ionclinics.com
+34674059324
Time Frame
Start Date: 2026-04-14
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 198
Treatments
Experimental: Accelerated home tDCS
Home tDCS applied over 3 weeks (42 sessions)
Active_comparator: Conventional home tDCS
Home tDCS applied over 9 weeks (42 sessions)
Active_comparator: Conventional ambulatory tDCS
Ambulatory tDCS applied over 9 weeks (42 sessions)
Related Therapeutic Areas
Sponsors
Collaborators: Hospital Universitari de Bellvitge, Consorci Sanitari del Maresme. Hospital Universitari de Mataró, Parc Taulí Hospital Universitari
Leads: Ionclinics & Deionic SL

This content was sourced from clinicaltrials.gov