[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635299":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":32,"responsibleParty":51,"collaborators":55,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":25,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":25,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":25,"overallStatus":35,"whyStopped":25,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Tongji University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dexmedetomidine Group","ACTIVE_COMPARATOR","30 μg (one spray of 15 μg per nostril) administered intranasally. Completed within 2 minutes",[13],"Drug: Dexmedetomidine",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Group","PLACEBO_COMPARATOR","Equal-volume placebo (normal saline) administered intranasally, one spray per nostril",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"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.",[9,15],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Yuan Shen, MD., Ph.D.","CONTACT","86-21-66111243","weiym@smhc.org.cn",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Tongji Hospital Affiliated with Tongji University","RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":42,"coordinates":43},"Point",[44,45],121.45806,31.22222,{"lat":45,"lon":44},[48],{"name":49,"role":29,"phone":50,"phoneExt":25,"email":31},"Shen Yuan PhD, PhD","+86 021 66111243",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Yuan Shen","MD., Ph.D.",[56,58,60,62,64,67,69],{"name":57,"class":6},"Second Xiangya Hospital of Central South University",{"name":59,"class":6},"Sir Run Run Shaw Hospital",{"name":61,"class":6},"Zhejiang University",{"name":63,"class":6},"Huzhou Third People's Hospital",{"name":65,"class":66},"NINGBO KANGNING HOSPITAL","UNKNOWN",{"name":68,"class":6},"Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University",{"name":70,"class":66},"Shanghai Putuo District People's Hospital","100635299","phase-2-intranasal-dexmedetomidine-for-acute-anxiety-state-in-adults-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":82,"type":83},150,"ESTIMATED","INTERVENTIONAL",[86],"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.",[89],"Acute Anxiety States","2026-06-06",{"date":92,"type":93},"2026-06-10","ACTUAL",{"date":95,"type":93},"2026-04-30",{"date":97,"type":83},"2027-07-31",{"name":5,"class":6},1]