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New treatment option for Major Depression Disorder
Official title Home tDCS for the Treatment of Major Depression.
ClinicalTrials.gov ID: NCT07510880
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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 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 likely can't join 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...
- Any exclusion criteria established by clinical guidelines on non-invasive brain stimulation (Woods et al., 2016): metal implants or head injuries...
- 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)...
- Drug or alcohol abuse during the study or in the previous 3 months (except for nicotine).
See the full eligibility 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- L'Hospitalet de Llobregat, Barcelona, Spain
- Mataró, Barcelona, Spain
- Sabadell, Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include L'Hospitalet de Llobregat, Barcelona, Spain; Mataró, Barcelona, Spain; Sabadell, Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.