[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06823024":3,"trial-entities:NCT06823024":98,"trial-summary:NCT06823024":106},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":24,"study_type":38,"primary_purpose":17,"phases":39,"enrollment_info":40,"interventions":43,"primary_outcomes":44,"secondary_outcomes":48,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":15,"eligibility_criteria":64,"std_ages":68,"locations":71,"central_contacts":88,"overall_officials":89,"references":93,"see_also_links":94},"NCT06823024","PSYRIN-0005","Assess the Utility of a Speech-based Machine Learning Algorithm to Predict Treatment Response to Psychiatric Interventions","An Observational, Prospective Study to Assess the Utility of a Speech-based Machine Learning Algorithm to Predict Treatment Response to Psychiatric Interventions","ENROLLING_BY_INVITATION","2026-03","2025-02","2025-03-18","2025-02-18","Psyrin Inc.","INDUSTRY",false,"This is a research study looking at whether the way people speak can help predict how well they'll respond to certain mental health treatments.\n\nThe Main Goal:\n\nThe researchers want to see if computer analysis of a person's speech patterns can predict whether they'll respond well to two specific treatments: TMS (Transcranial Magnetic Stimulation) and Spravato (a nasal spray medication). They're focusing on people with depression, bipolar disorder, OCD, anxiety, and PTSD.\n\nHow It Works:\n\n200 people with these conditions will participate in the study.Participants will record themselves speaking for about 12 minutes, responding to six different prompts.They'll do these recordings before treatment starts, daily during treatment, right after treatment ends, and again four weeks later. Doctors will track how well people are doing using various questionnaires and rating scales The researchers will look for connections between speech patterns and treatment success. The study will last 12 months.\n\nWhat Makes Someone a \"Treatment Success\":\n\nThe study considers treatment successful if a person's symptoms improve significantly (specifically, a 2-point or greater reduction on a clinical rating scale (called Clinical Global Impression) and stays improved during the follow-up period (4-weeks).\n\nWhy This Matters:\n\nIf successful, this research could lead to a simple, non-invasive way to help doctors predict which treatments might work best for different patients. This could help people get the most effective treatment more quickly and help healthcare providers use their resources more efficiently.\n\nSafety Consideration The researchers will also check whether doing the speech assessments causes any distress to participants, making sure the evaluation process itself is safe and comfortable.",null,[19,20,21,22,23],"Obsessive Compulsive Disorder (OCD)","Bipolar Disorders","Major Depressive Disorder","Post-Traumatic Stress Disorder, PTSD","Generalized Anxiety Disorder (GAD)",[25,26,27,28,29,30,31,32,33,34,35,36,37],"TMS","Spravato","Esketamine","Treatment response","Speech","Artificial Intelligence","Natural Language Processing","Acoustic Analysis","Acoustic Biomarkers","Vocal Biomarkers","Machine Learning","Mental Health","Speech Analysis","OBSERVATIONAL",[],{"count":41,"type":42},200,"ESTIMATED",[],[45],{"measure":28,"description":46,"timeFrame":47},"≥ 2 points symptom severity reduction between baseline and after-treatment evaluation on the clinical global impression severity scale (CGI-S) (between 1, normal, not at all ill, and 7, among the most extremely ill patients).","Change between Baseline and Week 0 (post-intervention)",[49,53,57],{"measure":50,"description":51,"timeFrame":52},"Remission","Symptoms below the threshold for having the disorder according to CGI-S and clinical judgement.","Change between Baseline and Week 0 (post-intervention), Week 4 (post-intervention)",{"measure":54,"description":55,"timeFrame":56},"Stability of treatment response","≥ 2 points symptom severity reduction between baseline and follow-up evaluation after-treatment on the clinical global impression severity scale (CGI-S) (between 1, normal, not at all ill, and 7, among the most extremely ill patients).","Change between Baseline and Week 4 (post-intervention)",{"measure":58,"description":59,"timeFrame":60},"Distress caused by the online speech assessment","Self-reported distress caused by the online speech assessment.","Week 4","ALL","18 Years","68 Years",{"inclusion":65,"exclusion":66,"raw_text":67},[],[],"Inclusion Criteria:\n\n1. Outpatient status\n2. Men and women aged 18-68 years\n3. Capable and willing to provide informed consent\n4. Able to adhere to the treatment schedule\n5. Stable on medication for at least 2 months with no anticipated changes during the study period\n6. Diagnosis of MDD, PTSD, or BD\n7. Eligible for and scheduled to receive TMS or Spravato (esketamine) treatment to alleviate symptoms of MDD, PTSD, GAD, OCD or BD\n8. Fluent in English\n9. Access to a stable internet connection and an electronic device with a microphone for voice recording\n\nExclusion Criteria:\n\n1. Use of any investigational drug within four weeks of the baseline visit\n2. If participating in psychotherapy, the patient must have been in stable treatment for at least three months before study entry, with no anticipated changes in the frequency of therapeutic sessions or therapeutic focus during the TMS or Spravato treatment.\n3. Intoxication during speech assessments\n4. Cognitive impairment that would interfere with study participation or data quality\n5. Lack of fluency in English",[69,70],"ADULT","OLDER_ADULT",[72,81],{"facility":73,"city":74,"state":75,"zip":76,"country":77,"geoPoint":78},"Acacia Clinics","Sunnyvale","California","94087","United States",{"lat":79,"lon":80},37.36883,-122.03635,{"facility":82,"city":83,"state":83,"zip":84,"country":77,"geoPoint":85},"Fermata Health","New York","11249",{"lat":86,"lon":87},40.71427,-74.00597,[],[90],{"name":91,"affiliation":13,"role":92},"Julianna Olah, B.Sc., M.A., M.Sc., Ph.D.","STUDY_DIRECTOR",[],[95],{"label":96,"url":97},"Study website","https:\u002F\u002Fwww.psyrin.ai\u002Fresearch",{"nct_id":4,"conditions":99,"biomarkers":105},[100,101,102,103,104],"Bipolar Disorder","Generalized Anxiety Disorder","Obsessive Compulsive Disorder","Post-Traumatic Stress Disorder","Unipolar Depression",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]