Depression - Major Depressive Disorder
Conditions
Keywords
tDCS, Major depression, EEG, Cost-effectiveness
Brief summary
The purpose of this randomized controlled trial is to investigate the non-inferiority, and possible superiority, of a high-dose home-based tDCS protocol compared with a conventional home-based protocol, and to assess its cost-effectiveness, in patients with major depression. As a secondary aim, we aim to assess the predictive value of baseline EEG for clinical response to high-dose home-based tDCS treatment in patients with major depression.
Interventions
DEVICEHigh-dose home-tDCS
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 (left dorsolateral prefrontal region) and the cathode to F8 (right supraorbital 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 home-tDCS
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 (left dorsolateral prefrontal region) and the cathode to F4 (left dorsolateral prefrontal region), described by Woodham et al., 2024. The application of tDCS will be carried out at home in this group. Each session will consist of 30 minutes of stimulation. Dose: (1) Week 1 to 3: 1ss/day for 5 days; (2) Week 4 to 10: 1ss/day for 3 days (total 36 sessions).
Sponsors
Ionclinics & Deionic SL
Hospital Universitario Doctor Peset
Universidad Europea de Valencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
EEG analyst will be blinded from group treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 years or over. * Patients diagnosed with Major Depressive Disorder with a current depressive episode, based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (American Psychiatric Association, 2013). * Score on the Hamilton Depression Rating Scale (HDRS-17) ≥16 (Hamilton et al., 1960). * Patients on a stable prescription of antidepressants/pharmacological medication and who agree to continue this throughout the study; and/or, if undergoing psychotherapy, who have maintained this treatment consistently for at least 6 weeks. * Demonstrate the ability to apply home-based tDCS appropriately, either independently or with the help of a carer. * Have access to an electronic device with a camera to enable monitoring of the intervention, as well as to contact the participant. * Have the ability and willingness to commit to the study team to complete all phases of the study. * Volunteer to participate and sign the specific informed consent form for this study.
Exclusion criteria
* Patients with a current manic episode as determined by the Young Mania Rating Scale (YMRS), or a psychotic episode as defined by the MINI scale. * Patients who answer 'yes' to questions 4, 5 or 6 of the Columbia Suicide Severity Rating Scale (C-SSRS), a risk assessment and identification tool. * Patients with treatment-resistant depression, defined as an inadequate clinical response to two or more courses of antidepressant treatment at appropriate doses and duration. * Any previous hospitalisation for suicidal behaviour. * Presenting with current chronic or severe insomnia (\< 4 hours' sleep per night) or sleep apnoea. * Presence of any structural lesion (e.g., any structural neurological condition or more subcortical lesions than would be expected for their age, or having suffered a stroke affecting the stimulated area or connected areas) or any other clinically significant abnormality that may affect safety, participation in the study, or confound the interpretation of study results, as determined by the investigator. * History or presence of any other condition or comorbidity associated with TDM: cardiac or neurological conditions, cognitive impairment. * History of or current diagnosis of any other mental disorder: obsessive-compulsive disorder, bipolar disorder (type 1 or 2), anxiety disorder, agoraphobia, eating disorders, personality disorders. * Any
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HDRS-17 | Baseline and end of treatment (week 3 for experimental; week 10 for active comparator). | Changes from baseline to the end of the treatment in the 17-items Hamilton Depression Rating Scale (HDRS-17). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MDRS | Baseline; end of treatment (3 week experimental; 10 week active comparator). | Changes from baseline to the end of treatment in the Montgomery-Åsberg Depression Rating Scale (MDRS). |
| C-SSRS | Baseline; end of treatment (3 week experimental; 10 week active comparator) | Changes from baseline to the end of treatment in the Columbia Suicide Severity Rating Scale (C-SSRS). |
| HAM-A | Baseline; end of treatment (3 week experimental; 10 week active comparator) | Changes from baseline to the end of treatment in the Hamilton Anxiety Rating Scale (HAM-A). |
| YMRS | Baseline; end of treatment (3 week experimental; 10 week active comparator) | Changes from baseline to the end of treatment in the Young Mania Rating Scale (YMRS). |
| RAVLT | Baseline; end of treatment (3 week experimental; 10 week active comparator) | Changes from baseline to the end of treatment in the Rey-Auditory Verbal Learning Test (RAVLT). |
| SDMT | Baseline; end of treatment (3 week experimental; 10 week active comparator). | Changes from baseline to the end of treatment in the Symbol Digit Modalities Test (SDMT). |
| Bristol stool scale | Baseline; end of treatment (3 week experimental; 10 week active comparator). | Changes from baseline to the end of treatment in the Bristol Stool Scale. |
| Mediterranean Diet Questionnaire | Baseline | Diet habits of the patients assessed with the Mediterranean diet questionnaire. |
| Meal frequency | Baseline | Meal frequency intake of patients prior to the starting of the project. |
| EQ-5D | Baseline; end of treatment (3 week experimental; 10 week active comparator). | Changes from baseline to the end of treatment in the EuroQoL-5D questionnaire (EQ-5D). |
| PGI-C | End of treatment (3 week experimental; 10 week active comparator) | Changes of impression at the end of treatment assess with the Patient Global Impression of Change (PGI-C). |
| Resting state EEG | Baseline | 32-channel active-electrode EEG (impedances \<5 kΩ) recordings in open and close eye conditions. |
| Stool samples | Baseline and end of treatment (week 3 for experimental; week 10 for active comparator). | Changes in stool sample biomarkers from baseline to end of treatment. |
Countries
Spain
Contacts
CONTACTAne Miren Gutiérrez Muto, PhD
CONTACTEnsayos Ionclinics
STUDY_DIRECTORAne Miren Gutiérrez Muto, PhD
Ionclinics & Deionics S.L.
STUDY_CHAIRMar Hernández Secorún, PhD
Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.
STUDY_CHAIRGustavo Sarriá Córdoba, MSc
Neuroscience in Physiotherapy independent research group; Ionclinics & Deionics S.L.
Outcome results
None listed