NCT07041073Recruiting
EEG-based Neurofeedback to Improve Emotion Regulation in Major Depressive Disorder: A Randomized Clinical Trial
Restoring Emotional Stability Through Neurofeedback and AI for Transformative Empowerment
Source: ClinicalTrials.gov · Last updated 27 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this clinical trial is to evaluate whether EEG-based neurofeedback targeting the emotion regulation network through swLORETA can improve emotional regulation and reduce symptoms in adults with Major Depressive Disorder (MDD) who have not responded sufficiently to first-line treatments. The main questions it aims to answer are: * Does EEG-neurofeedback improve emotional self-regulation and reduce clinical symptoms in patients with MDD with or without anxiety symptoms? * Are changes in EEG resting-state activity and stress biomarkers (e.g., cortisol) associated with clinical improvement? Researchers will compare an active neurofeedback group, a sham (placebo) neurofeedback group, and a treatment-as-usual control group to see if real-time EEG-neurofeedback leads to greater improvement in mood, emotional regulation, and neurophysiological indicators than placebo or no additional intervention. Participants will: * Receive 10 sessions of either real or sham EEG-neurofeedback (or no sessions in the control group) over 5 weeks. * Complete clinical, psychological, and neurophysiological assessments before (week 0) and after the intervention (week 6). * Provide repeated saliva samples to assess stress-related biomarkers at week 0 and week 6. * Continue their standard pharmacological treatment throughout the study.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- First submitted
- 18 Jun 2025
- Start date
- 19 May 2025
- Primary completion date
- Mar 2026
- Lead sponsor
- Corporacion Parc Tauli
- Diseases
- Depression
- NCT number
- NCT07041073
What you commit to
- Study type: Interventional
- Planned participants: 72
- From 19 May 2025 to the primary completion date, Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with a concurrent diagnosis of MDD and other severe psychiatric disorders.
Other illness
- Patients with serious physical illnesses that could interfere with study participation or the interpretation of results.
- Intellectual disability or conditions that interfere with the ability to provide informed consent and complete the intervention (e.g., severe visual or hearing impairments).
Other
- 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).
- Pregnancy.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Corporació Sanitària Parc Taulí de Sabadell Coordinator of this site? Confirm its status | Sabadell | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.