EEG Prediction and Clinical Efficacy of tDCS in Major Depression

ConditionDepression - Major Depressive Disorder

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorIonclinics & Deionic SL

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

High-dose home-tDCS
Device
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).
Conventional home-tDCS
Device
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).

Treatment groups

270 Participants

are divided into 2 treatment groups

Group A: High-dose home-tDCSExperimental treatment 1 intervention

Group B: Conventional home-tDCSActive comparator 1 intervention

Trial outcomes

Primary outcomes

HDRS-17

Changes from baseline to the end of the treatment in the 17-items Hamilton Depression Rating Scale (HDRS-17).

Time frame

Baseline and end of treatment (week 3 for experimental; week 10 for active comparator).

Secondary outcomes

MDRS

Changes from baseline to the end of treatment in the Montgomery-Åsberg Depression Rating Scale (MDRS).

Time frame

Baseline; end of treatment (3 week experimental; 10 week active comparator).

C-SSRS

Changes from baseline to the end of treatment in the Columbia Suicide Severity Rating Scale (C-SSRS).

Time frame

Baseline; end of treatment (3 week experimental; 10 week active comparator)

HAM-A

Changes from baseline to the end of treatment in the Hamilton Anxiety Rating Scale (HAM-A).

Time frame

Baseline; end of treatment (3 week experimental; 10 week active comparator)

YMRS

Changes from baseline to the end of treatment in the Young Mania Rating Scale (YMRS).

Time frame

Baseline; end of treatment (3 week experimental; 10 week active comparator)

Other outcomes

MINI

Score of items "Psychotic Disorder" in the MINI International. Neuropsychiatric Interview for selection criteria.

Time frame

Baseline

Responders to tDCS

A subject is considered a responder if: - Improvement of 50% or more in HDRS-17 or MADRS from baseline to immediate post-treatment.

Time frame

Through study completion, an average of 2 years.

Incremental Cost Effectiveness Ratio

Incremental Cost Effectiveness Ratio (ICER) will be derived from clinical effectiveness, utility and costs.

Time frame

Through study completion, an average of 2 years.

Adverse Effect

A daily questionnaire about adverse effects will be completed at the end of the last intervention of the day.

Time frame

End-of-day application (Experimental: 7 days per week through 3 weeks; Active Comparator: From week 1 to 3, 5 days per week; From week 4 to 10, 3 days per week).

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ionclinics & Deionic SL

Lead sponsor

Hospital Universitario Doctor Peset

Collaborator

Universidad Europea de Valencia

Collaborator

Source ClinicalTrials.gov

Apply now