[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05803551":3,"trial-entities:NCT05803551":105,"trial-summary:NCT05803551":108},{"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":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":42,"secondary_outcomes":55,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":15,"eligibility_criteria":59,"std_ages":82,"locations":85,"central_contacts":95,"overall_officials":96,"references":100,"see_also_links":101},"NCT05803551","22-004767","A Study of Ketamine Infusions to Treat Clinically-depressed ICU Patients","A Phase II Randomized, Double Blind, Placebo-Controlled Study Evaluating the Effects of Ketamine Infusions in Clinically Depressed ICU Patients","TERMINATED","2026-07-15","2026-08","2026-08-12","2025-07-07","Mayo Clinic","OTHER",false,"The purpose of this research is to study the effects of intravenous ketamine infusions for the treatment of patients with depressive symptoms in intensive care unit (ICU).",null,[19],"Depression",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},1,"ACTUAL",[29,37],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"DRUG","Ketamine Hydrochloride","Intravenous 0.5 mg\u002Fkg infusions of ketamine for three consecutive days, 24 hours apart, with no more than 1mg\u002Fkg or 60 mg\u002Fday regardless of body weight",[34],"Ketamine Group",[36],"Ketalar",{"type":30,"name":38,"description":39,"armGroupLabels":40},"Placebo","Intravenous 0.9% saline infusions for three consecutive days.",[41],"Placebo Group",[43,47,51,53],{"measure":44,"description":45,"timeFrame":46},"Change in depressive symptoms","Evaluated by Patient Health Questionnaire-9 (PHQ-9) used to assess degree of depression severity rating symptoms on a scale of 0=not at all, 3=nearly everyday. Higher score indicates greater depression severity.","Baseline, 7 days after third infusion",{"measure":48,"description":49,"timeFrame":50},"Clinically significant improvement of depressive symptoms","Number of subjects to show clinically significant improvement in depressive symptoms, defined as a reduction in the PHQ-9 of 5 points or more.","24 hours after initial infusion",{"measure":48,"description":49,"timeFrame":52},"24 hours after third infusion",{"measure":48,"description":49,"timeFrame":54},"14 days after third infusion",[],"ALL","18 Years","99 Years",{"inclusion":60,"exclusion":64,"raw_text":81},[61,62,63],"Has been in the Mayo Clinic Florida ICU for the past 1 week.","PHQ-9 score of 10 or higher.","One of the following diagnoses: acute myocardial infarction; acute renal failure; chronic obstructive pulmonary disease (COPD); congestive heart failure; end-stage liver disease; patients requiring intra-aortic balloon pump (IABP) therapy or continuous renal replacement therapy (CRRT); post-bone marrow transplant; acute Hypoxemic Respiratory Failure; acute or chronic hypoxemic respiratory failure; pre- or post- lung, liver or heart transplant or surgical overflows (such as abdominal aortic aneurysm, thoracotomy or tracheostomy).",[65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80],"Poor vital sign stability hypoxia: O2 \\\u003C 95%, hypotension: SBP \\\u003C 90 hypertension: SBP \\> 180.","Heart rate: \\\u003C 50 or \\> 120, or Respiratory Rate: \\\u003C 10 or \\> 30.","Altered mental status.","Patient is unwilling to participate or provide informed consent.","Any allergy to ketamine or diphenhydramine.","Patient is female of child-bearing age and unwilling to provide urine or blood for HCG analysis.","Pregnant or breastfeeding.","Presence of intracranial mass or vascular lesion.","Presence of a history of psychosis or hallucinations (as assessed by electronic chart review).","Weight greater than 115 kg or less than 45kg.","History of increased intracranial pressure\u002Fhypertensive hydrocephalus or increased intraocular pressure.","Patient is acutely psychotic.","Provider feels that patient currently or likely will require chemical and\u002For physical restraints.","History of prolonged QT-interval.","Current treatment includes any medication known to affect the N-methyl-D-aspartate receptor system (e.g., lamotrigine, acamprosate, memantine, riluzole, or lithium).","Patient in withdrawal from substance abuse or who have used hallucinogens (including cannabis) in the last month for any indication, as determined by the clinical interview and urine drug screening.","Inclusion Criteria:\n\n* Has been in the Mayo Clinic Florida ICU for the past 1 week.\n* PHQ-9 score of 10 or higher.\n* One of the following diagnoses: acute myocardial infarction; acute renal failure; chronic obstructive pulmonary disease (COPD); congestive heart failure; end-stage liver disease; patients requiring intra-aortic balloon pump (IABP) therapy or continuous renal replacement therapy (CRRT); post-bone marrow transplant; acute Hypoxemic Respiratory Failure; acute or chronic hypoxemic respiratory failure; pre- or post- lung, liver or heart transplant or surgical overflows (such as abdominal aortic aneurysm, thoracotomy or tracheostomy).\n\nExclusion Criteria:\n\n* Poor vital sign stability hypoxia: O2 \\\u003C 95%, hypotension: SBP \\\u003C 90 hypertension: SBP \\> 180.\n* Heart rate: \\\u003C 50 or \\> 120, or Respiratory Rate: \\\u003C 10 or \\> 30.\n* Altered mental status.\n* Patient is unwilling to participate or provide informed consent.\n* Any allergy to ketamine or diphenhydramine.\n* Patient is female of child-bearing age and unwilling to provide urine or blood for HCG analysis.\n* Pregnant or breastfeeding.\n* Presence of intracranial mass or vascular lesion.\n* Presence of a history of psychosis or hallucinations (as assessed by electronic chart review).\n* Weight greater than 115 kg or less than 45kg.\n* History of increased intracranial pressure\u002Fhypertensive hydrocephalus or increased intraocular pressure.\n* Patient is acutely psychotic.\n* Provider feels that patient currently or likely will require chemical and\u002For physical restraints.\n* History of prolonged QT-interval.\n* Current treatment includes any medication known to affect the N-methyl-D-aspartate receptor system (e.g., lamotrigine, acamprosate, memantine, riluzole, or lithium).\n* Patient in withdrawal from substance abuse or who have used hallucinogens (including cannabis) in the last month for any indication, as determined by the clinical interview and urine drug screening.",[83,84],"ADULT","OLDER_ADULT",[86],{"facility":87,"city":88,"state":89,"zip":90,"country":91,"geoPoint":92},"Mayo Clinic Florida","Jacksonville","Florida","32224","United States",{"lat":93,"lon":94},30.33218,-81.65565,[],[97],{"name":98,"affiliation":13,"role":99},"Devang Sanghavi, MBBS, MD","PRINCIPAL_INVESTIGATOR",[],[102],{"label":103,"url":104},"Mayo Clinic Clinical Trials","https:\u002F\u002Fwww.mayo.edu\u002Fresearch\u002Fclinical-trials",{"nct_id":4,"conditions":106,"biomarkers":107},[19],[],{"nct_id":4,"found":109,"summary":110,"prompt_version":120},true,{"design":111,"status":112,"heading":113,"summary":114,"follow_up":115,"word_count":116,"commitments":117,"compensation":118,"drugs_mentioned":119},"This is an interventional study planning to enroll 50 participants. It compares ketamine hydrochloride infusions to a placebo.","completed","Ketamine Infusions for Depression in ICU Patients","This study is looking at whether intravenous (IV) infusions of ketamine hydrochloride can help treat depression in patients who are in the intensive care unit (ICU). You might be able to join if you are in the Mayo Clinic Florida ICU, are between 18 and 99 years old, and have a PHQ-9 score (a measure of depression symptoms) of 10 or higher. You also need to have one of several specific medical conditions, such as a heart attack or congestive heart failure. Researchers will compare ketamine to a placebo (a salt water solution) to see if ketamine can reduce depressive symptoms within 24 hours and up to 7 days after the infusions. The current status of this study is unclear.","Participants will be followed for 7 days after the third infusion to assess changes in depressive symptoms.",120,"Participants will receive intravenous infusions for three consecutive days, 24 hours apart. The study measures changes in depressive symptoms at baseline, 24 hours after the first and third infusions, and 7 days after the third infusion.","Not stated in the trial record.",[31,38],"v2"]