[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06867549":3,"trial-entities:NCT06867549":110,"trial-summary:NCT06867549":113},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":49,"secondary_outcomes":54,"sex":55,"minimum_age":56,"maximum_age":57,"healthy_volunteers":58,"eligibility_criteria":59,"std_ages":82,"locations":85,"central_contacts":104,"overall_officials":106,"references":108,"see_also_links":109},"NCT06867549","202411168","Slow Wave Induction by Propofol to Eliminate Depression (SWIPED) Stage II","RECRUITING","2028-05-01","2026-08","2026-08-27","2025-03-04","Washington University School of Medicine","OTHER",true,"The investigators hypothesize that brief behavioral therapy and targeted propofol infusion in depressed geriatric patients will augment subsequent slow wave sleep and improve clinical and cognitive outcomes. The team will recruit 70 participants for a double-blinded placebo controlled randomized controlled trial. Two propofol infusions, 2-6 days apart, will be administered, targeting either a low propofol dose arm (minimal EEG slow waves, brain effect-site concentration 1-2 mcg\u002Fml) or moderate dose propofol arm (maximal induction of EEG slow waves, brain effect site concentration of \\>2.5 mcg\u002Fml). The pharmacologic intervention will be paired with 3-4 sessions of Brief Behavioral Therapy for Insomnia for all participants. To minimize bias, there will be no specific gender or ethnic background consideration for enrollment. This will be a single site investigation at Washington University Medical Center.","Depression in older adults is a leading cause of disability, excess mortality from suicide, and dementia. Cognitive problems and sleep disturbances are common, contributing to recurrence and poor long-term outcomes. Disrupted slow-wave sleep is at the nexus of depression and cognitive dysfunction in older adults. Novel approaches to target this core pathophysiology are lacking. This mechanistic project is designed to elucidate the relationships between TRD and sleep disturbances in older adults. Through personalized infusions targeting electroencephalographic (EEG) patterns, the investigators aim for a systematic characterization of the relationships between the propofol (dose and EEG measures) and enhancement of slow wave sleep, with associated secondary clinical and cognitive outcomes. Through the re-purposing of propofol as a therapeutic probe, this innovative proposal will establish whether EEG slow waves are a viable therapeutic target for novel antidepressant approaches.\n\nTwo BBTI sessions will be administered before the propofol infusions, with two additional sessions within 6 weeks after the 2nd infusion. The sessions will completed remotely or in person.\n\nPropofol will be infused through a peripheral IV, with the assistance of target-controlled infusion software and pumps, with an anticipated infusion duration of 2 hours. Concurrent high-density EEG will be acquired. Participants will be discharged home after nurse monitoring and fulfillment of post-anesthetic care unit criteria.\n\nPatients will be instructed by staff on the operation of the SOMNOmedics HST for at-home overnight sleep EEG recordings. Patients will demonstrate the ability to successfully wear the device and initiate recordings without assistance. The device, charger, tablet, and instructional materials will be provided to patients.\n\nOvernight sleep recordings will be obtained prior to the first propofol infusion and on evenings of propofol infusions. Additionally, recordings will be obtained for up to 6 weeks after the final infusion, to evaluate persistence of restoration of sleep architecture.\n\nPrimary endpoints will be analyzed based on age, sex, time separating propofol infusions, induction of EEG measures during infusions, pharmacokinetic exposure times at varying concentrations, adherence to BBTI, and concomitant medications.",[18],"Depression",[],"INTERVENTIONAL","BASIC_SCIENCE",[23],"PHASE2",{"count":25,"type":26},70,"ESTIMATED",[28,37,42],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":35},"DRUG","Propofol","Targeted propofol infusion in TRD patients will induce sedation. Dosage of propofol is determined based upon EEG markers and treatment arm.",[33,34],"Propofol infusion - low dose","Propofol infusion -moderate dose",[36],"anesthetic",{"type":38,"name":39,"description":40,"armGroupLabels":41},"DIAGNOSTIC_TEST","Electroencephalography (EEG)","EEG will be recorded during propofol infusion and during overnight sleep. Sleep EEG data will be acquired for a minimum of one night prior to the first sedation session, providing a baseline measure. Additional overnight sleep recordings will be performed on day of sedation and subsequent nights.",[33,34],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"BEHAVIORAL","Brief Behavioral Therapy for Insomnia","Trained staff will provide evaluation and up to 3 follow up appointments of BBTI for all participants. These will be done remotely to assess behavioral approaches to improve overall sleep habits.",[33,34],[48],"BBTI",[50],{"measure":51,"description":52,"timeFrame":53},"Change in SWS duration","This is the total duration of N3 averaged across infusion nights relative to baseline average. The average change in total duration of N3 infusion nights relative to baseline.","Pre-infusion and on the nights of propofol infusions",[],"ALL","60 Years",null,false,{"inclusion":60,"exclusion":66,"raw_text":81},[61,62,63,64,65],"Provision of signed and dated informed consent form","Stated willingness to comply with all study procedures and availability for the duration of the study","Age 60 or greater","English speaking (as an interpreter will not be readily available should a participant need to convey any safety concerns during the propofol infusion sessions or require guidance on conducting at-home sleep recordings)","Depression (non-responsive to at least one adequate trial of oral antidepressants for current episode).",[67,68,69,70,71,72,73,74,75,76,77,78,79,80],"Presence of symptomatic coronary artery disease","Presence of marked congestive heart failure\u002Fcardiomyopathy(NYHA \\> Class III, LVEF \\\u003C40%, greater than mild RV systolic dysfunction)","Prior reaction to propofol","Resting heart rate \\\u003C 50 bpm","Treatment with Electroconvulsive therapy\u002FTranscranial Magnetic Stimulation\u002Fvagal nerve stimulation within 6 weeks","Body mass index \\> 35","C-SSRS of 4 or greater (active suicidal ideation with some intent and with\u002Fwithout a specific plan)","MoCA score \\\u003C 23 (at least mild dementia)","Schizophrenia","Bipolar disorder","Non-prescribed use of amphetamines, opioids, cocaine, or phencyclidine; Urine THC \\> 150 ng\u002Fml","Intake of \\> 14 beers\u002Fweek (or equivalent)","Anesthetic exposure in the past 4 weeks","Concurrent use of benzodiazepines \\> 2 mg\u002Fday lorazepam or equivalent, trazodone \\> 50 mg\u002Fday, or gabapentin \\> 600mg\u002Fday.","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Age 60 or greater\n* English speaking (as an interpreter will not be readily available should a participant need to convey any safety concerns during the propofol infusion sessions or require guidance on conducting at-home sleep recordings)\n* Depression (non-responsive to at least one adequate trial of oral antidepressants for current episode).\n\nExclusion Criteria:\n\n* Presence of symptomatic coronary artery disease\n* Presence of marked congestive heart failure\u002Fcardiomyopathy(NYHA \\> Class III, LVEF \\\u003C40%, greater than mild RV systolic dysfunction)\n* Prior reaction to propofol\n* Resting heart rate \\\u003C 50 bpm\n* Treatment with Electroconvulsive therapy\u002FTranscranial Magnetic Stimulation\u002Fvagal nerve stimulation within 6 weeks\n* Body mass index \\> 35\n* C-SSRS of 4 or greater (active suicidal ideation with some intent and with\u002Fwithout a specific plan)\n* MoCA score \\\u003C 23 (at least mild dementia)\n* Schizophrenia\n* Bipolar disorder\n* Non-prescribed use of amphetamines, opioids, cocaine, or phencyclidine; Urine THC \\> 150 ng\u002Fml\n* Intake of \\> 14 beers\u002Fweek (or equivalent)\n* Anesthetic exposure in the past 4 weeks\n* Concurrent use of benzodiazepines \\> 2 mg\u002Fday lorazepam or equivalent, trazodone \\> 50 mg\u002Fday, or gabapentin \\> 600mg\u002Fday.",[83,84],"ADULT","OLDER_ADULT",[86],{"facility":87,"status":7,"city":88,"state":89,"zip":90,"country":91,"contacts":92,"geoPoint":101},"Washington University School of Medicine\u002FBarnes-Jewish Hospital","St Louis","Missouri","63110","United States",[93,98],{"name":94,"role":95,"phone":96,"email":97},"Sarah E Knarr","CONTACT","314-362-2415","knarr.sarah@wustl.edu",{"name":99,"role":100},"Ben Palanca, MD PhD","PRINCIPAL_INVESTIGATOR",{"lat":102,"lon":103},38.62727,-90.19789,[105],{"name":94,"role":95,"phone":96,"email":97},[107],{"name":99,"affiliation":12,"role":100},[],[],{"nct_id":4,"conditions":111,"biomarkers":112},[18],[],{"nct_id":4,"found":14,"summary":114,"prompt_version":124},{"design":115,"status":116,"heading":117,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This is a double-blinded, placebo-controlled randomized study planning to enroll 70 participants. Participants will be assigned to either a low-dose or moderate-dose propofol group.","completed","SWIPED Stage II: Propofol for Depression in Older Adults","This study, called SWIPED Stage II, is looking at new ways to help older adults with depression. Researchers are testing if a medicine called propofol, given in a targeted way, along with Brief Behavioral Therapy for Insomnia (BBTI), can improve sleep and depression symptoms. You would receive two propofol infusions, which involve a short-acting sedative, and have your brain waves measured with an electroencephalogram (EEG) during and after. All participants will also receive 3-4 remote sessions of BBTI to help with sleep habits. The study aims to see if increasing a specific type of sleep, called slow wave sleep, can lead to better mood and thinking. They plan to enroll 70 participants aged 60 or older who speak English. The study status is unclear, so it's not known if they are currently enrolling.","Two BBTI sessions will be administered within 6 weeks after the second infusion.",133,"You would have two propofol infusions 2-6 days apart, each lasting about 2 hours, with EEG recordings. You would also have at least one overnight sleep EEG before the first infusion and additional overnight sleep recordings on the day of and nights after infusions. Additionally, you would participate in up to 3 follow-up remote BBTI appointments.","Not stated in the trial record.",[30,44],"v2"]