Home tDCS for the Treatment of Major Depression.
Recruiting · NCT07510880 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Accelerated protocol of home Transcranial direct current stimulationConventional protocol of home Transcranial direct current stimulationConventional protocol of in person Transcranial direct current stimulation
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
3 locations listed.
- Hospital Universitario de Bellvitge - L'Hospitalet de Llobregat, Barcelona, Spain
- Hospital Universitari de Mataró - Mataró, Barcelona, Spain
- Parc Taulí Hospital Universitari - Sabadell, Barcelona, Spain