EEG neurofeedback to improve emotion regulation in major depression
Restoring Emotional Stability Through Neurofeedback and AI for Transformative Empowerment
This trial will test whether EEG-based neurofeedback can help adults with major depressive disorder, including those with anxiety symptoms, improve emotion regulation and reduce depressive symptoms after not responding well to first-line treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Corporacion Parc Tauli Academic / other |
| Locations | 1 site (Sabadell, Barcelona, Cataluña) |
| Trial ID | NCT07041073 on ClinicalTrials.gov |
What this trial studies
This single-blind, randomized, placebo-controlled trial will enroll 72 adults (18–65) with DSM-5 major depressive disorder and MADRS scores ≥20 who have had an insufficient response to first-line medications. Participants will be randomized to active swLORETA Z-score EEG-neurofeedback, yoked-sham neurofeedback, or treatment-as-usual, with the active arm receiving 10 gamified training sessions over five weeks using a 24-channel EEG system. The protocol targets fronto-limbic regions implicated in emotion regulation (including anterior cingulate, medial prefrontal cortex, amygdala, and insula) using the NeuroGuide® swLORETA platform to provide real-time feedback. Outcomes include changes in emotional regulation and depressive symptoms, with secondary measures of resting-state EEG and stress biomarkers such as cortisol.
Who should consider this trial
Good fit: Adults 18–65 with DSM-5 major depressive disorder, a MADRS score of at least 20, and on stable psychopharmacological treatment for at least six weeks, including those with comorbid anxiety symptoms, are ideal candidates.
Not a fit: Patients with active suicidal ideation, significant other psychiatric disorders, serious physical illnesses, or those already in structured psychotherapy are excluded and may not benefit from this protocol.
Why it matters
Potential benefit: If effective, the approach could offer a non-drug option that improves emotional regulation and reduces depressive and anxiety symptoms for patients who have not responded to first-line medications.
How similar studies have performed: Prior small EEG-neurofeedback studies in depression have shown promising but inconsistent results, so robust randomized placebo-controlled evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A primary diagnosis of Major Depressive Disorder (MDD), established by qualified psychiatrists according to DSM-5 criteria. * Patients with comorbid anxiety or anxiety symptoms will be included, provided that MDD is the primary diagnosis. * Participants must score at least 20 on the Montgomery-Åsberg Depression Rating Scale (MADRS), indicating a moderate level of depression. * All participants must be on a stable psychopharmacological treatment for at least 6 weeks before beginning of the study. Exclusion Criteria: * Patients with a concurrent diagnosis of MDD and other severe psychiatric disorders. * Patients with serious physical illnesses that could interfere with study participation or the interpretation of results. * Participants currently undergoing structured psychotherapy or other interventions unrelated to standard psychopharmacological treatment. * Patients presenting with active suicidal ideation, as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS), at the time of screening will not be eligible due to associated risks. * Active substance abuse or dependence (except nicotine). * Intellectual disability or conditions that interfere with the ability to provide informed consent and complete the intervention (e.g., severe visual or hearing impairments). * Pregnancy.
Where this trial is running
Sabadell, Barcelona, Cataluña
- Corporació Sanitària Parc Taulí de Sabadell — Sabadell, Barcelona, Cataluña, Spain (Recruiting)
Study contacts
- Study coordinator: Virginia Soria, MD,PhD
- Email: vsoria@gmail.com
- Phone: +34 937231010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.