[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635299":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":50,"studyPopulation":50,"armGroups":60,"interventions":72,"overallOfficials":50,"centralContacts":78,"locations":84,"responsibleParty":103,"collaborators":107,"id":123,"slug":50,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":50,"eligibilityCriteria":128,"healthyVolunteers":124,"sex":129,"minAge":130,"maxAge":131,"enrollmentInfo":132,"targetDuration":50,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":50,"overallStatus":87,"whyStopped":50,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Tongji University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":42},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of patients with a CGI-I score≤ 2.","The Clinical Global Impression - Improvement (CGI-I) scale is used to assess how much the patient's illness has improved or worsened relative to a baseline state. A score of 1 (Very Much Improved) or 2 (Much Improved) indicates a significant clinical response","15 minutes post-administration",[14,18,22,26,30,33,36,39],{"measure":15,"description":16,"timeFrame":17},"Proportion of patients with a CGI-I score≤ 2 at multiple time points","CGI-I ranges from 1 (normal) to 7 (among the most extremely ill patients). This measure assesses the change in severity from baseline","30, 45, 60, 90, and 120 minutes post-administration",{"measure":19,"description":20,"timeFrame":21},"Change in Clinical Global Impression - Severity (CGI-S) scores","CGI-S ranges from 1 (normal) to 7 (among the most extremely ill patients). This measure assesses the change in severity from baseline","Baseline and at 15, 30, 45, 60, 90, and 120 minutes post-administration",{"measure":23,"description":24,"timeFrame":25},"Change in STAI-S-6 scale scores","The 6-item State-Trait Anxiety Inventory (STAI-S-6) scores range from 6 to 24, with higher scores indicating more severe anxiety","Baseline and at 15, 30, and 120 minutes post-administration",{"measure":27,"description":28,"timeFrame":29},"Change from baseline in the count of concomitant symptoms","Based on DSM-5 criteria, 13 symptoms of acute anxiety are assessed (e.g., palpitations, sweating, trembling). The investigator counts the number of symptoms present. A decrease in count indicates symptomatic relief","Baseline and at 15, 30, and 120 minutes post-administration.",{"measure":31,"description":32,"timeFrame":21},"Change from baseline in the Numerical Rating Scale (NRS) score for subjective anxiety severity","Patients rate their current level of anxiety on a scale of 0 to 10, where 0 is \"not at all\" and 10 is \"the most severe\". A higher score represents more severe anxiet",{"measure":34,"description":35,"timeFrame":25},"Change from baseline in the Richmond Agitation-Sedation Scale (RASS) score","The RASS is used to assess the level of alertness and agitation. Scores range from +4 (combative) to -5 (unarousable), with 0 being \"alert and calm\"",{"measure":37,"description":38,"timeFrame":21},"Change from baseline in heart rate","Heart rate is measured in beats per minute (bpm) to monitor the drug's effect on autonomic activity and safety",{"measure":40,"description":41,"timeFrame":21},"Change from baseline in systolic and diastolic blood pressure","Blood pressure is measured in mmHg. Both systolic and diastolic values will be recorded to evaluate hemodynamic stability",[43],{"measure":44,"description":45,"timeFrame":46},"Exploratory Endpoints：Changes in peripheral blood levels of biomarkers","Measurement of norepinephrine (NE), cortisol, and inflammatory cytokines (e.g., IL-6). These serve as physiological markers of stress and treatment response","Baseline (pre-administration) and at 90-120 minutes post-administration",{"allocation":48,"interventionModel":49,"interventionModelDescription":50,"primaryPurpose":51,"observationalModel":50,"timePerspective":50,"maskingInfo":52},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":53,"maskingDescription":54,"whoMasked":55},"QUADRUPLE","multicenter, randomized, double-blind, placebo-controlled, parallel-group superiority study",[56,57,58,59],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[61,67],{"label":62,"type":63,"description":64,"interventionNames":65},"Dexmedetomidine Group","ACTIVE_COMPARATOR","30 μg (one spray of 15 μg per nostril) administered intranasally. Completed within 2 minutes",[66],"Drug: Dexmedetomidine",{"label":68,"type":69,"description":70,"interventionNames":71},"Placebo Group","PLACEBO_COMPARATOR","Equal-volume placebo (normal saline) administered intranasally, one spray per nostril",[66],[73],{"type":74,"name":75,"description":76,"armGroupLabels":77,"otherNames":50},"DRUG","Dexmedetomidine","Patients meeting the criteria for acute anxiety who provided informed consent and met the inclusion and exclusion criteria were randomized in a 1:1 ratio to the placebo group or the study drug group and entered the double-blind study.",[62,68],[79],{"name":80,"role":81,"phone":82,"phoneExt":50,"email":83},"Yuan Shen, MD., Ph.D.","CONTACT","86-21-66111243","weiym@smhc.org.cn",[85],{"facility":86,"status":87,"city":88,"state":89,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"Tongji Hospital Affiliated with Tongji University","RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":94,"coordinates":95},"Point",[96,97],121.45806,31.22222,{"lat":97,"lon":96},[100],{"name":101,"role":81,"phone":102,"phoneExt":50,"email":83},"Shen Yuan PhD, PhD","+86 021 66111243",{"type":104,"investigatorFullName":105,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"PRINCIPAL_INVESTIGATOR","Yuan Shen","MD., Ph.D.",[108,110,112,114,116,119,121],{"name":109,"class":6},"Second Xiangya Hospital of Central South University",{"name":111,"class":6},"Sir Run Run Shaw Hospital",{"name":113,"class":6},"Zhejiang University",{"name":115,"class":6},"Huzhou Third People's Hospital",{"name":117,"class":118},"NINGBO KANGNING HOSPITAL","UNKNOWN",{"name":120,"class":6},"Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University",{"name":122,"class":118},"Shanghai Putuo District People's Hospital","100635299",false,"NCT07550881","Intranasal Dexmedetomidine for Acute Anxiety State in Adults","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating the Efficacy and Safety of Dexmedetomidine Hydrochloride Nasal Spray for the Treatment of Acute Anxiety States in Adults","Inclusion Criteria:\n\n1. No gender restrictions; during screening: age must be between 18 and 65 years;\n2. Meet the criteria for acute anxiety, defined as subjective anxiety or worry accompanied by at least four associated symptoms, with a CGI-S score of ≥4;\n3. Voluntarily participate in this study and sign an informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Acute anxiety states caused by other psychoactive substances; history of abuse of psychotropic or anesthetic drugs; 2. Use of sedative-hypnotic drugs at the time of enrollment and still in the washout period; 3. Use of alpha-adrenergic agonists (e.g., norepinephrine, methoxamine, methoxamine hydrochloride, epinephrine, clonidine hydrochloride tablets, midodrine hydrochloride tablets, etc.) or beta-blockers (e.g., metoprolol, etc.) within the past 12 hours; 4. Patients with allergies to the active ingredients or components of the study drugs (e.g., dexmedetomidine) or those with a history of three or more allergic reactions to various allergens; 5. Endocrine system disorders, such as hypoglycemia, pheochromocytoma, hyperthyroidism, or hypothyroidism; 6. Cardiovascular diseases, including myocardial infarction or unstable angina within the 6 months prior to screening; heart rate \\\u003C60 beats per minute during screening; History of severe arrhythmias, such as second-degree type II atrioventricular block or higher; poorly controlled blood pressure (hypertension: systolic blood pressure ≥180 mmHg and\u002For diastolic blood pressure ≥110 mmHg, or hypotension: systolic blood pressure \\\u003C90 mmHg and\u002For diastolic blood pressure ≤50 mmHg); 7. Cerebrovascular diseases, such as a history of ischemic stroke or transient ischemic attack; 8. Respiratory diseases, such as asthma, pulmonary embolism, chronic obstructive pulmonary disease, or pneumonia; history of difficult airway management or assessed potential risk, such as obstructive sleep apnea syndrome or asthma; 9. History of severe hepatic or renal insufficiency; 10. History of epilepsy; 11. Pregnant or lactating women; 12. Other conditions deemed unsuitable for enrollment by the investigator.","ALL","18 Years","65 Years",{"count":133,"type":134},150,"ESTIMATED","INTERVENTIONAL",[137],"PHASE2","This study employs a randomized, double-blind, placebo-controlled clinical trial design to evaluate the efficacy and safety of dexmedetomidine hydrochloride nasal spray in the treatment of acute anxiety in adults.\n\nStudy Protocol: Patients meeting the criteria for acute anxiety who provided informed consent and met the inclusion and exclusion criteria were randomized in a 1:1 ratio to the placebo group or the study drug group and entered the double-blind study. Upon enrollment, baseline assessments were conducted to evaluate the number of accompanying symptoms, subjective anxiety severity (NRS), STAI-S-6, CGI-S, and RASS. Immediately following these assessments, patients received a nasal spray of 30 μg of dexmedetomidine or an equal-volume placebo; the time of administration was recorded as 0 minutes. At 15, 30, 45, 60, 90, and 120 minutes post-administration, the NRS for subjective anxiety severity, CGI-S, and CGI-I were assessed. The count of accompanying symptoms, STAI-S-6, and RASS were re-assessed only at 15, 30, and 120 minutes post-administration. In addition, vital signs (heart rate, oxygen saturation, and blood pressure) were assessed and recorded at baseline (prior to administration) and at 15, 30, 45, 60, 90, and 120 minutes post-administration. Venous blood samples were collected prior to administration and 90-120 minutes post-administration to measure biological markers. Adverse events were monitored during a 7-day follow-up period after treatment.",[140],"Acute Anxiety States","2026-06-06",{"date":143,"type":144},"2026-06-10","ACTUAL",{"date":146,"type":144},"2026-04-30",{"date":148,"type":134},"2027-07-31",{"name":5,"class":6},1]