Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 65

Intranasal Dexmedetomidine for Acute Anxiety in Adults

Official title: 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

Run by Tongji University · NCT07550881 · Data updated 2026-11-12

This study tests whether a nasal spray of dexmedetomidine helps adults with acute anxiety compared with a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment150 (estimated)
SponsorTongji University
Academic / other
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedApril 30, 2026
Main results expectedDecember 31, 2026
Study endsJuly 31, 2027
Registry record updatedJune 10, 2026
Trial IDNCT07550881 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18–65 with acute anxiety and at least four accompanying symptoms, plus a CGI-S score of 4 or higher, who can provide informed consent.

Probably not a fit

Patients whose anxiety is not primarily responsive to central nervous system sedatives or who meet exclusion criteria may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2, randomized, double-blind, placebo-controlled trial enrolls adults aged 18–65 with acute anxiety who meet predefined criteria. Participants receive either dexmedetomidine hydrochloride nasal spray (30 μg) or an equal-volume placebo, with assessments of anxiety severity and related scales at baseline and multiple time points up to 120 minutes post-dose. Primary aim is to determine safety and initial efficacy in reducing subjective anxiety and related symptoms. The study uses standard inclusion/exclusion criteria to minimize confounding factors and is conducted across multiple hospital sites in China under lead sponsor Tongji University and collaborating centers.

Why it matters

Potential benefit: If successful, the treatment could provide rapid relief of acute anxiety symptoms in adults.

How similar studies have gone: Previous studies in similar contexts have explored intranasal anxiolytics; the efficacy of dexmedetomidine for acute anxiety is being tested in this trial.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. No gender restrictions; during screening: age must be between 18 and 65 years;
2. 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;
3. Voluntarily participate in this study and sign an informed consent form.

Exclusion Criteria:

* 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 \<60 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/or diastolic blood pressure ≥110 mmHg, or hypotension: systolic blood pressure \<90 mmHg and/or 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.

Where it's running

  • Tongji Hospital Affiliated with Tongji University
    Shanghai, Shanghai Municipality, China
    Recruiting

Study contacts

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.