[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"physiologic-effects-of-drugs\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:physiologic-effects-of-drugs":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,63],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":44,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100573936","phase-3-nebulized-ketamine-for-the-treatment-of-major-depressive-disorder-100573936",false,"NCT06752759","Nebulized Ketamine for the Treatment of Major Depressive Disorder","Nebulized Ketamine for the Treatment of Major Depressive Disorder in an Inpatient Setting: A Midazolam-controlled Randomized Controlled Trial","Inclusion Criteria:\n\n* All individuals 18 years and older with a Montgomery-Asberg Depression Rating Scale score (MADRS) ≥ 20\n* Must have a diagnosis of moderate to severe Major Depressive Disorder (MDD)\n* Structured Clinical Interview for DSM-5 (SCID-5) will be performed to confirm MDD diagnosis\n\nExclusion Criteria:\n\n* Adult patients with an allergy to Ketamine\n* Adult patients with an allergy to Midazolam\n* Individuals with a history of mania\u002Fhypomania or diagnosis of bipolar disorder\n* Patients on lithium and\u002For lamotrigine therapy\n* Recent or current homicidal ideation with an intent to act\n* MDD with psychotic features or current or past diagnosis of a psychotic disorder\n* No substance use disorder in the preceding 3 months except nicotine or caffeine or a positive urine screen for substances (except cannabis)\n* Diagnosis of obsessive-compulsive disorder, antisocial personality disorder, borderline personality disorder, posttraumatic stress disorder, intellectual disability, altered mental status, pregnant or breastfeeding patients,\n* Patients on \\> 2 medications for hypertension\n* Patients with uncontrolled hypertension (BP \\>140 mm Hg systolic and\u002For \\>90 mm Hg diastolic on two separate readings at the time of screening)\n* Body weight of \\> 150kg\n* Patients with history of congestive cardiac failure\n* Day of presentation, patients with unstable vital signs (systolic blood pressure \\\u003C90 or\\>160 mm Hg, pulse rate \\\u003C50 or \\>150 beats\u002Fmin, and respiration rate \\\u003C10 or \\>30 breaths\u002Fmin)\n* Consumption of opioids within 24 hours of drug administration\n* Acutely intoxicated patients will also be excluded","ALL","18 Years","88 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a double-blind active placebo controlled clinical trial for individuals with moderate to severe depression. The purpose of this study is to assess if nebulized ketamine can reduce depressive symptoms.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],"Severe Depression","Moderate Depression","Ketamine","Midazolam","Peripheral Nervous System Agents","Central Nervous System Agents","Neurotransmitter Agents","Physiologic Effects of Drugs","Sensory System Agents","Analgesics, Non-Narcotic","Anti-Inflammatory Agents, Non-Steroidal","Depressive Symptom","Hypnotics and Sedatives","Anti-anxiety Agents","Tranquilizing Agents","Psychotropic Drugs","Anesthetics Agent",[45,46,29,30,31,35,47,48,49],"Maimonides Medical Center","Psychiatry","Anesthetics, Dissociative","Nebulized Medications for depression","GABA Agents","RECRUITING","2026-04-21",{"date":53,"type":54},"2026-04-24","ACTUAL",{"date":56,"type":54},"2024-10-16",{"date":58,"type":21},"2027-09-30",{"name":60,"class":61},"Theresa Jacob, PhD, MPH","OTHER",1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100445392","phase-4-the-stimulation-to-induce-mothers-study-100445392","NCT05079841","The Stimulation To Induce Mothers Study","The Stimulation To Induce Mothers (STIM) Study: A Parallel Group Randomized Controlled Trial","STIM","Inclusion Criteria:\n\n* Nulliparous\n* Gestational age 36 0\u002F7 weeks and greater at enrollment\n* Singleton gestation\n* Planned to undergo initiation of exogenous oxytocin infusion by their maternity care provider\n* Spontaneous rupture of membranes or if membranes intact, modified Bishop score ≥5 and cervix dilated \\\u003C6 cm within one hour of enrollment\n* Ability to give informed consent\n\nExclusion Criteria:\n\n* Unable to understand English or Spanish\n* Prior use of exogenous oxytocin or attempt at nipple stimulation during the current pregnancy\n* Presence of tachysystole (defined as more than 5 contractions in 10 minutes averaged over 30 minutes), recurrent variable or late fetal decelerations, and bradycardia in the prior 30 minutes before enrollment\n* Non-vertex presenting fetus at time of enrollment\n* Planned for cesarean delivery or contraindication to labor by institutional policy (e.g., placenta previa, vasa previa, active genital herpes infection, previous transmural myomectomy)\n* Multi-fetal gestation (e.g., twins, triplets, and higher-order multiples)\n* Intrauterine fetal death\n* Major fetal anomaly suspected prenatally (defined as a fetal anomaly with anticipated neonatal intensive care unit admission)\n* Suspected alloimmunization (given the increased likelihood for anticipated neonatal intensive care unit admission)\n* Known severe fetal growth restriction (estimated fetal weight \\\u003C3rd percentile) or abnormal umbilical artery Doppler studies (given the increased likelihood for anticipated neonatal intensive care unit admission)\n* HIV infection (nipple stimulation is not encouraged given the recommendation for these mothers not to breastfeed)\n* Participation in another interventional study that influences management of labor and delivery or perinatal morbidity or mortality\n* History of mastectomy or other contraindication to use of electronic breast pump\n* Known allergic reactions to components of the electronic breast pump or to synthetic oxytocin intravenous solution\n* Significantly impaired consciousness or executive function (e.g., intubated or sedated)",true,"FEMALE",{"count":74,"type":21},988,[76],"PHASE4","The investigators propose a parallel group randomized clinical trial of intrapartum nipple stimulation versus exogenous oxytocin infusion for nulliparous women undergoing induction of labor near term. The central hypothesis is that intrapartum nipple stimulation to induce labor increases spontaneous vaginal delivery, improves patient-centered outcomes such as childbirth satisfaction, labor agentry, and pain scores, and reduces adverse neonatal and maternal outcomes in nulliparous women. The investigators will pursue the following specific aims: 1) Assess the effectiveness of intrapartum nipple stimulation on the rate of spontaneous vaginal delivery in nulliparous women, 2) Breastfeeding as the sole source of nutrition at time of maternal hospital discharge (Primary Aims); 3) Maximal percent newborn weight loss during the birth hospitalization within 72 hours of life, 4) Determine the effect of intrapartum nipple stimulation on the rate of adverse maternal and neonatal outcomes, 5) Determine the impact of intrapartum nipple stimulation on patient-centered outcomes and 6) In a sub-cohort of women who are enrolled in the trial, investigators will measure the change in oxytocin concentration from baseline to time at which patient achieves a regular contraction pattern.",[79,80,81,34],"Oxytocin","Labor Pain","Induction of Labor Affected Fetus \u002F Newborn","2026-03-19",{"date":84,"type":54},"2026-03-24",{"date":86,"type":54},"2021-11-15",{"date":88,"type":21},"2029-03",{"name":90,"class":61},"Yale University",3]