[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614395":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":12,"locations":18,"responsibleParty":32,"collaborators":34,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":7,"studyType":54,"phases":7,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":62,"whyStopped":7,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},{"fullName":5,"class":6},"Deliberate Solutions Inc.","INDUSTRY",null,[9],{"name":10,"affiliation":5,"role":11},"Marc Aafjes","PRINCIPAL_INVESTIGATOR",[13],{"name":14,"role":15,"phone":16,"phoneExt":7,"email":17},"Eric Storch, PhD","CONTACT","713-798-3579","research@sequoiastudy.com",[19],{"facility":20,"status":7,"city":21,"state":22,"zip":23,"country":24,"countryCode":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":7},"Baylor College of Medicine","Houston","Texas","77030","United States","US",{"type":27,"coordinates":28},"Point",[29,30],-95.36327,29.76328,{"lat":30,"lon":29},{"type":33,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[35,37],{"name":20,"class":36},"OTHER",{"name":38,"class":39},"National Institute of Mental Health (NIMH)","NIH","100614395","pivotal-us-clinical-validation-of-ai-coa-for-depression-and-anxiety-100614395",false,"NCT07279038","Pivotal U.S. Clinical Validation of AI-COA® for Depression and Anxiety","Symptom Evaluation and Quantification for Unified Outcomes and Individualized Assessment: Pivotal Clinical Validation Phase","SEQUOIA-3","Inclusion Criteria:\n\n* English fluency\n* 18 to 65 years of age.\n* Diagnosed with MDD or MDE (Includes Remission, HAM-D \\\u003C= 7)\n* Starting, or has started, a new treatment for depression or anxiety within 2-3 weeks of enrollment\n* Access to a laptop or other computer with a well functioning microphone and webcam, and a stable Internet connection\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Resides in the United States at the time of consent and during completion of study\n\nExclusion Criteria:\n\n* Any cognitive impairment that limits ability to provide informed consent or authorization\n* Vulnerable or protected populations (e.g. prisoners)\n* Impairment that would prevent participants from completing an online survey and\u002For engaging in clinician assessment interviews (e.g., visual impairment, motor impairment, hearing impairment)\n* Acute intoxication at the time of the assessments\n* Concurrent medication\u002Ftreatment:\n\n  * Receiving any fast-acting treatment for depression or anxiety (e.g. ketamine, psychedelics, deep brain stimulation, etc.) in between initial baseline assessment (A1) and Restest (A2) , or in between Follow up assessment (B1) and Retest (B2)\n  * Anxiolytics: Use of benzodiazepines or other anxiety-reducing medications that could affect speech or motor activity, within the past 4 weeks.\n  * Antipsychotics and Mood Stabilizers: Medications that can alter cognitive and motor functions, within the past 6 weeks.\n  * Stimulants: Use of medications like methylphenidate or amphetamines that affect energy levels and behavior, within the past 2 weeks\n  * Epilepsy medication: seizure activity or medication side effects that may alter behavior, within the past 4 weeks.\n* Any history or evidence of any of the following conditions:\n\n  * Neurodevelopmental, Neurocognitive, Neurodegenerative or movement disorders including, but not limited to:\n  * Tourette's syndrome\n  * Multiple Sclerosis\n  * Amyotrophic Lateral Sclerosis\n  * Parkinson's Disease\n  * Stroke\n  * Traumatic Brain Injury\n  * Facial paralysis.\n* Conditions with vocal cord impact:\n\n  * Vocal cord injury or cerebrovascular accident or head trauma with residual dysarthria in the past year\n  * Disorders that may impact vocal cords such as acute or chronic laryngitis, vocal cord paresis or paralysis, or spasmodic dysphonia\n  * Past or active heavy smokers (an average of \\>20 cigarettes per day)\n* Schizophrenia Spectrum and Other Psychotic Disorders:\n\n  * Individuals with a current or past diagnosis of Schizophrenia, Schizoaffective Disorder, or other psychotic disorders, including Delusional Disorder and Brief Psychotic Disorder.\n  * Current hypomanic episode as defined by DSM-5 criteria. This includes those with Bipolar I Disorder, Bipolar II Disorder, or Cyclothymic Disorder who are not in a stable mood state at the time of assessment.\n  * Chronic Pain Conditions: Such as fibromyalgia, which may affect facial expressions and vocal tone.\n  * Prosthetic Facial Devices: Could affect facial recognition algorithms. Cosmetic Procedures: Such as Botox injections or facelifts that can impact facial expressions.\n  * Dental Work: Major procedures that might affect speech.\n* Participants who have previously participated in another research project by Deliberate.","ALL","18 Years","65 Years",{"count":52,"type":53},650,"ESTIMATED","OBSERVATIONAL","This study is a large-scale pivotal clinical validation of the AI-COA® software device. The purpose is to confirm the tool's accuracy and performance across a demographically diverse population of adults with Major Depressive Disorder (MDD), ensuring it functions fairly and reliably across different subgroups.",[57,58],"Depression Disorders","Anxiety Disorders",[60,61],"depression assessment","anxiety assessment","NOT_YET_RECRUITING","2025-12-07",{"date":65,"type":66},"2025-12-12","ACTUAL",{"date":68,"type":53},"2027-03-01",{"date":70,"type":53},"2029-08-28",{"name":5,"class":6},1]