EEG Prediction and Clinical Efficacy of tDCS in Major Depression
Trial statusNot yet recruiting
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
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
Treatments tested in this trial
- High-dose home-tDCS
- Conventional home-tDCS
Treatment groups
270 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ionclinics & Deionic SL
Lead sponsor
Hospital Universitario Doctor Peset
Collaborator
Universidad Europea de Valencia
Collaborator
Source ClinicalTrials.gov