[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591622":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":43,"responsibleParty":107,"collaborators":37,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":37,"eligibilityCriteria":115,"healthyVolunteers":111,"sex":116,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":37,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":46,"whyStopped":37,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"GrayMatters Health Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active arm","ACTIVE_COMPARATOR","Participants randomized into the Active arm will receive reward system EEG-fMRI pattern (RS-EFP) Neuro Feedback (NF) Prism training as an adjunct to SOC.",[13],"Device: Prism Training",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham arm","SHAM_COMPARATOR","Participants randomized into the Sham arm will receive a Sham EFP-NF training with the same schedule as the active arm, adjunct to SOC.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Prism Training","Participants will complete 20 Prism training sessions. The Prism training sessions take place twice a week over a 10-week period, with a minimum of one night of sleep between sessions. Participants will also receive two single booster sessions, 4 weeks and 8 weeks after their last NF session completed.",[9,15],[26],"Sham Training",[28],{"name":29,"affiliation":30,"role":31},"Aron Tendler, MD","GrayMatters Health","STUDY_DIRECTOR",[33,39],{"name":34,"role":35,"phone":36,"phoneExt":37,"email":38},"Adar Shani, MSc","CONTACT","+972-54-2347770",null,"adar@graymatters-health.com",{"name":40,"role":35,"phone":41,"phoneExt":37,"email":42},"Jennifer Yarden, PhD","+972-52-4897823","jennifer@graymatters-health.com",[44,66,87],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Butler Hospital","RECRUITING","Providence","Rhode Island","02906","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-71.41283,41.82399,{"lat":56,"lon":55},[59,63],{"name":60,"role":35,"phone":61,"phoneExt":37,"email":62},"Eric Tirrell","401-455-6633","ETirrell@Butler.org",{"name":64,"role":65,"phone":37,"phoneExt":37,"email":37},"Linda Carpenter, MD","PRINCIPAL_INVESTIGATOR",{"facility":67,"status":46,"city":68,"state":69,"zip":70,"country":50,"countryCode":51,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Houston Center For Advanced Psychiatric Treatment","Houston","Texas","77401",{"type":53,"coordinates":72},[73,74],-95.36327,29.76328,{"lat":74,"lon":73},[77,81,85],{"name":78,"role":35,"phone":79,"phoneExt":37,"email":80},"Sarah Hartigan","832-730-5196","sarah@sprashadmd.com",{"name":82,"role":35,"phone":83,"phoneExt":37,"email":84},"Crystal Islas","(832) 436-4055 x110","crystal@sprashadmd.com",{"name":86,"role":65,"phone":37,"phoneExt":37,"email":37},"Sandhya Prashad, MD",{"facility":88,"status":46,"city":89,"state":37,"zip":37,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Sheba Medical Center","Ramat Gan","Israel","IL",{"type":53,"coordinates":93},[94,95],34.81065,32.08227,{"lat":95,"lon":94},[98,102,105],{"name":99,"role":35,"phone":100,"phoneExt":37,"email":101},"Sharon Baltansky, B.A.","052-6668419","Innomind.research@sheba.health.gov.il",{"name":103,"role":35,"phone":100,"phoneExt":37,"email":104},"Maayan Nur, M. S C","Maayan.Nur@sheba.health.gov.il",{"name":106,"role":65,"phone":37,"phoneExt":37,"email":37},"Raz Gross, MD",{"type":108,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100591622","self-neuro-modulation-therapy-for-major-depressive-disorder-mdd-with-anhedonia-100591622",false,"NCT06982820","Self Neuro-modulation Therapy for Major Depressive Disorder (MDD) With Anhedonia","A Prospective, Randomized, Double-blind, Controlled Study to Produce Guidelines for Integrating Prism for MDD Therapy (Reward System [RS] Upregulation) and to Demonstrate Its Superiority Over Sham Therapy","Inclusion Criteria:\n\n1. Primary Diagnosis of MDD with Anhedonia, established according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM5TR) - HDRS-17 score of ≥20, SHAPS-C score of ≥25.\n2. Fluency in written and spoken English.\n3. Able intellectually to understand the instructions\n4. Ability to give signed, informed consent either written or electronic (via REDCap eConsent).\n5. Normal or corrected-to-normal vision and hearing.\n6. Ability to adhere to the study schedule.\n7. Completed at least one antidepressant treatment course at an adequate dose and duration in the current episode per the ATRQ.\n\nExclusion Criteria:\n\n1. Contraindications to MRI (e.g., metal in the body, claustrophobia).\n2. Any suicidal behavior in the past 1 year (i.e., actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior) assessed using Columbia -Suicide Severity Rating Scale (C-SSRS) prior to screening and during the screening period.\n3. Diagnosis for current moderate or severe substance or alcohol use disorder (SUD\u002FAUD) within the past month (as defined in DSM-5-substance use disorder).\n4. Any unstable medical condition, as per the clinical judgement of the investigator.\n5. Any change in, or initiation of, fluoxetine within the past 8 weeks or of other SSRIs\u002FSNRIs antidepressants, bupropion, stimulants, or other psychiatric medications within the past 4 weeks.\n6. Recent initiation (within the past 2 months) of psychotherapy; continuation of established maintenance supportive therapy will be permitted.\n7. Enrollment in another therapeutic clinical study at screening or within 2 months prior to screening or intended enrollment within the duration of this study.","ALL","22 Years","75 Years",{"count":120,"type":121},170,"ESTIMATED","INTERVENTIONAL",[124],"NA","The purpose of this research is to learn more about a new treatment for individuals with Major Depressive Disorder (MDD) with heightened symptoms of anhedonia (i.e. loss of pleasure or interest in activities). The treatment is called Prism, and it is a software device intended for a novel form of neurofeedback training to be used in a clinic setting.\n\nDuring this study, the subject will use different techniques to measure brain activities, including magnetic resonance imaging (MRI) and electroencephalography (EEG).",[127],"Depressive Disorder, Major",[129,130,131],"Major Depressive Disorder (MDD)","Anhedonia","Depression","2026-04-30",{"date":134,"type":135},"2026-05-01","ACTUAL",{"date":137,"type":135},"2025-06-25",{"date":139,"type":121},"2027-08-30",{"name":5,"class":6},3]