Home tDCS for the Treatment of Major Depression.
ConditionMajor Depression Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIonclinics & Deionic SL
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Accelerated protocol of home Transcranial direct current stimulation
- Conventional protocol of home Transcranial direct current stimulation
- Conventional protocol of in person Transcranial direct current stimulation
Treatment groups
198 Participants
are divided into 3 treatment groupsSponsors and collaborators
Ionclinics & Deionic SL
Lead sponsor
Hospital Universitari de Bellvitge
Collaborator
Consorci Sanitari del Maresme. Hospital Universitari de Mataró
Collaborator
Parc Taulí Hospital Universitari
Collaborator
Source ClinicalTrials.gov