[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570286":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":57,"studyPopulation":57,"armGroups":64,"interventions":76,"overallOfficials":57,"centralContacts":84,"locations":57,"responsibleParty":90,"collaborators":57,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":57,"enrollmentInfo":104,"targetDuration":57,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":120,"whyStopped":57,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":57},{"fullName":5,"class":6},"Stanford University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Change in clinician-rated depression severity","The Montgomery-Asberg Depression Rating Scale (MADRS) assesses the severity of depressive symptoms experienced by an individual. Items are clinician-rated on a 7-point scale tailored to each depression-related symptom (e.g. sleep, appetite, energy level). Higher total scores indicate greater depression symptom severity.","From Day 0 pre-intervention baseline to 1, 2, and 3 days post-intervention",[14],{"measure":15,"description":16,"timeFrame":17},"Antidepressant response rate","Defined as ≥50% reduction of MADRS scores from Day 0 pre-intervention baseline","From Day 0 pre-intervention baseline to 1, 2, 3, 7, and 14 days post-intervention",[19,23,26,29,32,35,39,43,47,50],{"measure":20,"description":21,"timeFrame":22},"Self-rated depression symptoms","Patient Health Questionnaire-9 (PHQ-9)","From 7 days pre-intervention to 14 days post-intervention",{"measure":24,"description":25,"timeFrame":22},"Anxiety symptoms","The 7-item Generalized Anxiety Disorder (GAD-7) Scale assesses the severity of anxiety symptomsover the past two weeks. Items are self-rated on a 4-point scale ranging from 0 (\"Not at all\") to 3 (\"Nearly every day\"), reflecting the frequency of symptoms. Higher total scores indicate greater anxiety symptom severity.",{"measure":27,"description":28,"timeFrame":22},"Sleep disturbance","The 8-item PROMIS Sleep Disturbance Short Form",{"measure":30,"description":31,"timeFrame":22},"Anhedonia","The 14-item Snaith-Hamilton Pleasure Scale (SHAPS) measures an individual's capacity to experience pleasure from various activities over the past two weeks, the absence of which indicates anhedonia. Items are self-rated on a 4-point scale ranging from 0 (\"Strongly disagree\") to 3 (\"Strongly agree\"). Lower total scores indicate greater degree of anhedonia.",{"measure":33,"description":34,"timeFrame":22},"Participant expectations","Participants will be asked to rate how effective they expect their treatment to be on a scale from 0 (not effective at all) to 100 (completely effective) and indicate the amount of confidence they have on a scale from 0% to 100%.",{"measure":36,"description":37,"timeFrame":38},"Perceived EEG credibility for depression symptoms","Participants will be asked to rate how much their EEG credibly reflects their current depression symptoms on a scale from 0 (none at all) to 100 (completely).","Immediately after the educational intervention",{"measure":40,"description":41,"timeFrame":42},"Sedation awareness","The modified Brice Questionnaire will be used to evaluate what the participant remembers between the time of induction and their awakening from sedation.","Immediately upon recovery from sedation",{"measure":44,"description":45,"timeFrame":46},"Resting state alpha peak frequency","Peak frequency (Hz) within the alpha band (8-13 Hz) of the eyes-closed resting-state EEG power spectrum at occipital electrodes, derived via Fast Fourier Transform (FFT) spectral analysis.","Baseline (prior to infusion)",{"measure":48,"description":49,"timeFrame":46},"Resting state frontal theta power","Relative power within the theta band (4-8 Hz) of the eyes-closed resting-state EEG power spectrum at frontal electrodes, derived via Fast Fourier Transform (FFT) spectral analysis.",{"measure":51,"description":52,"timeFrame":53},"Adverse events","Safety will be assessed by tracking the number and severity of adverse events spontaneously reported by the participant and through surveillance of medical records (if available) by the research team. Suicidality will be specifically monitored using the Columbia Suicide Severity Rating Scale.","From enrollment to 14 days post-intervention",{"allocation":55,"interventionModel":56,"interventionModelDescription":57,"primaryPurpose":58,"observationalModel":57,"timePerspective":57,"maskingInfo":59},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":60,"maskingDescription":57,"whoMasked":61},"DOUBLE",[62,63],"PARTICIPANT","OUTCOMES_ASSESSOR",[65,71],{"label":66,"type":67,"description":68,"interventionNames":69},"Response-focused education","ACTIVE_COMPARATOR","Patient education that is focused on treatment response",[70],"Behavioral: Response-focused education",{"label":72,"type":67,"description":73,"interventionNames":74},"Diagnosis-focused education","Patient education that is focused on the diagnosis of major depressive disorder",[75],"Behavioral: Diagnosis-focused education",[77,81],{"type":78,"name":66,"description":79,"armGroupLabels":80,"otherNames":57},"BEHAVIORAL","Once participants recover from sedation, they will receive education that is focused on their response to treatment.",[66],{"type":78,"name":72,"description":82,"armGroupLabels":83,"otherNames":57},"Once participants recover from sedation, they will be provided education that is focused on their diagnosis of major depressive disorder.",[72],[85],{"name":86,"role":87,"phone":88,"phoneExt":57,"email":89},"Theresa Lii, MD, MS","CONTACT","650-264-9442","sagestudy@stanford.edu",{"type":91,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":57,"oldOrganization":57},"PRINCIPAL_INVESTIGATOR","Theresa Lii","Principal Investigator","100570286","sedation-and-guided-education-for-depression-study-100570286",false,"NCT06705270","Sedation and Guided Education for Depression Study","Randomized Controlled Trial Comparing the Impact of Patient Education Strategies on the Antidepressant Response to Propofol Sedation","SAGE","Inclusion Criteria:\n\n* Diagnosis of major depressive disorder of at least moderate severity\n* Able to read, understand, and provide written informed consent\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Certain substance use disorders\n* Daily use of opioids and\u002For benzodiazepines\n* History of psychosis, schizophrenia, or schizoaffective disorder\n* Body mass index greater than 35 kg\u002Fm2\n* Obstructive sleep apnea that is moderate and untreated, or severe\n* Any gastrointestinal condition placing the patient at significant risk of aspiration","ALL","18 Years",{"count":105,"type":106},20,"ESTIMATED","INTERVENTIONAL",[109],"NA","The goal of this clinical trial is to understand how patient education surrounding a one-time, consciousness-altering medical intervention impacts the antidepressant response to the intervention in adults with major depressive disorder. In this study, the consciousness-altering medical intervention is a single infusion of propofol, an intravenous anesthetic which might have antidepressant properties.\n\nThe main question this study aims to answer is: Does the focus of patient education influence the antidepressant response to a single intravenous infusion of propofol?\n\nResearchers will compare response-focused vs. diagnosis-focused education.\n\nQualifying participants will:\n\n* Undergo a single intravenous infusion of propofol which will induce a temporary state of sedation\n* Wear an EEG cap that records brain activity during sedation\n* Be randomized to receive either response-focused or diagnosis-focused education about their brain signals after they recover from sedation\n* Be asked to fill out surveys about their mood and other measures of well-being before and after treatment",[112],"Major Depressive Disorder (MDD)",[114,115,116,117,118,119],"Propofol","Sedation","Patient education","Antidepressant","Major depressive disorder","Electroencephalography","NOT_YET_RECRUITING","2026-09-11",{"date":123,"type":124},"2026-09-15","ACTUAL",{"date":126,"type":106},"2026-09",{"date":128,"type":106},"2028-10",{"name":5,"class":6}]