[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"major-depression-with-comorbid-anxiety-symptoms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:major-depression-with-comorbid-anxiety-symptoms":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100596101","eeg-based-neurofeedback-to-improve-emotion-regulation-in-major-depressive-disorder-a-randomized-clinical-trial-100596101",false,"NCT07041073","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","RESoNATE","Inclusion Criteria:\n\n* A primary diagnosis of Major Depressive Disorder (MDD), established by qualified psychiatrists according to DSM-5 criteria.\n* Patients with comorbid anxiety or anxiety symptoms will be included, provided that MDD is the primary diagnosis.\n* Participants must score at least 20 on the Montgomery-Åsberg Depression Rating Scale (MADRS), indicating a moderate level of depression.\n* All participants must be on a stable psychopharmacological treatment for at least 6 weeks before beginning of the study.\n\nExclusion Criteria:\n\n* Patients with a concurrent diagnosis of MDD and other severe psychiatric disorders.\n* Patients with serious physical illnesses that could interfere with study participation or the interpretation of results.\n* Participants currently undergoing structured psychotherapy or other interventions unrelated to standard psychopharmacological treatment.\n* 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.\n* Active substance abuse or dependence (except nicotine).\n* Intellectual disability or conditions that interfere with the ability to provide informed consent and complete the intervention (e.g., severe visual or hearing impairments).\n* Pregnancy.","ALL","18 Years","65 Years",{"count":21,"type":22},72,"ESTIMATED","INTERVENTIONAL",[25],"NA","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:\n\n* Does EEG-neurofeedback improve emotional self-regulation and reduce clinical symptoms in patients with MDD with or without anxiety symptoms?\n* Are changes in EEG resting-state activity and stress biomarkers (e.g., cortisol) associated with clinical improvement?\n\nResearchers 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.\n\nParticipants will:\n\n* Receive 10 sessions of either real or sham EEG-neurofeedback (or no sessions in the control group) over 5 weeks.\n* Complete clinical, psychological, and neurophysiological assessments before (week 0) and after the intervention (week 6).\n* Provide repeated saliva samples to assess stress-related biomarkers at week 0 and week 6.\n* Continue their standard pharmacological treatment throughout the study.",[28,29],"Major Depression With Comorbid Anxiety Symptoms","Major Depressive Disorder (MDD)",[31,32,33,34,35,36],"neurofeedback","eeg","MDD","anxiety","depression","emotion regulation","RECRUITING","2025-06-18",{"date":40,"type":41},"2025-06-27","ACTUAL",{"date":43,"type":41},"2025-05-19",{"date":45,"type":22},"2026-09",{"name":47,"class":48},"Corporacion Parc Tauli","OTHER"]