EEG neurofeedback to improve emotion regulation in major depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• EEG microstates and inflammatory markers in treatment-resistant depression patients undergoing ECT

  This study tests how electroconvulsive therapy affects brain activity patterns seen in EEG and inflammatory biomarkers in adults with treatment-resistant major depression.

  Recruiting Istanbul University - Cerrahpasa · Istanbul, Bakırköy · NCT07748091

• Emotional Reactivity in Severe Alcohol Use Disorder and Depression Using Eye-Tracking and Physiological Measures

  This study tests how people with severe alcohol use disorder, major depressive disorder, both conditions, or neither, recognize and react to emotions using eye-tracking and physiological data.

  Recruiting Université Catholique de Louvain · Brussels, Belgium · NCT07925281

• Temporally Interfering Electrical Stimulation for Major Depressive Disorder

  This study tests whether noninvasive temporally interfering electrical stimulation can help people with major depressive disorder.

  Recruiting at 2 sites Tianjin Medical University General Hospital · Fuzhou, Fujian and 1 other locations · NCT07924917

• Affective Cognitive Training for mood disorders and their close relatives

  A six-week program combining virtual reality and computer exercises tests whether affective cognitive training helps people with mood disorders and their unaffected first-degree relatives.

  Recruiting Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · Frederiksberg, Capital Region of Denmark · NCT07920302

• ALKS 7290 added to antidepressants for adults with major depression

  This study tests whether ALKS 7290, taken with current antidepressants, helps adults with major depressive disorder.

  Recruiting Phase 2 Alkermes, Inc. · Jacksonville, Florida · NCT07901179

• French Minds: a French, Multimodal Cohort Study of Severe Psychiatric Disorders and Healthy Controls

  This study tests whether people with mood, psychotic, or autism disorders can be grouped into more similar subtypes based on social withdrawal and anhedonia, across ages 15 to 60.

  Recruiting at 10 sites Fondation FondaMental · Besançon and 16 other locations · NCT07881016

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.