Major Depression Disorder
Conditions
Keywords
Major Depression, Electric Stimulation Therapy, Transcranial Direct Current Stimulation
Brief 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.
Interventions
DEVICEAccelerated protocol of home Transcranial direct current stimulation
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique in which a weak direct current (2 mA) is applied to the scalp via electrodes. The anode will be applied to F3 (the dorsolateral prefrontal cortex) and the cathode to F8 (the contralateral frontotemporal region). The application of tDCS will be carried out at home in this group. Each session will consist of 20 minutes of stimulation. Dose: 3 weeks, daily. (1) 1st week - 3 times per day; (2) 2nd Week - 2 times per day; (3) 3rd week - 1 time per day (total of 42 sessions).
DEVICEConventional protocol of home Transcranial direct current stimulation
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique in which a weak direct current (2 mA) is applied to the scalp via electrodes. The anode will be applied to F3 (the dorsolateral prefrontal cortex) and the cathode to F8 (the contralateral frontotemporal region). The application of tDCS will be carried out at home in this group. Each session will consist of 20 minutes of stimulation. Dose: 9 weeks, from Monday to Friday. 1 time per day (total of 42 sessions).
DEVICEConventional protocol of in person Transcranial direct current stimulation
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique in which a weak direct current (2 mA) is applied to the scalp via electrodes. The anode will be applied to F3 (the dorsolateral prefrontal cortex) and the cathode to F8 (the contralateral frontotemporal region). The application of tDCS will be carried out at the medical facilities. Each session will consist of 20 minutes of stimulation. Dose: 9 weeks, from Monday to Friday. 1 time per day (total of 42 sessions).
Sponsors
Ionclinics & Deionic SL
Hospital Universitari de Bellvitge
Consorci Sanitari del Maresme. Hospital Universitari de Mataró
Parc Taulí Hospital Universitari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Although it is impossible to blind participants due to the nature of the study, the evaluator and statistician will be blinded.
Intervention model description
Randomized, parallel, double-blind, multicentre clinical trial. Recruited subjects will be randomised into three groups: conventional tDCS at a healthcare centre (control intervention), conventional tDCS at home, and accelerated tDCS at home (allocation ratio of 1:1:1).
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MADRS | End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm. | Mean score change based on Montgomery-Asberg Depression Rating Scale (MADRS) of the three arms at the end of the treatment compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MADRS | 2nd week of treatment. | Mean score change based on Montgomery-Asberg Depression Rating Scale (MADRS) of the three arms at the end of the second week of treatment compared to baseline. |
| HDRS-17 | End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm. | Mean score change based on Hamilton Depression Rating Scale (HDRS) of the three arms at the end of the treatment compared to baseline. |
| HARS | End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm. | Mean score change based on Hamilton Anxiety Rating Scale (HARS) of the three arms at the end of the treatment compared to baseline. |
| PHQ9 | End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm. | Mean score change based on Patient Health Questionnaire-9 (PHQ9) of the three arms at the end of the treatment compared to baseline. |
| Clinical Global Impression | End of treatment: 3 week for Accelerated home-tDCS arm; 9 week for Conventional home-tDCS and ambulatory tDCS arm. | Score based on Clinical Global Impression of the three arms at the end of the treatment. |
Countries
Spain
Contacts
CONTACTAne Miren Gutiérrez Muto, PhD
CONTACTEnsayos Ionclincs
STUDY_DIRECTORAne Miren Gutiérrez Muto
Ionclinics & Deionics S.L.
STUDY_CHAIRMar Hernández Secorún
Ionclinics & Deionics S.L.
STUDY_CHAIRGustavo Sarriá Córdoba
Ionclinics & Deionics S.L.
Outcome results
None listed