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

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.

Study 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.

Study Overview

• Status: Recruiting
• Conditions: Acute Anxiety States
• Intervention / Treatment: Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yuan Shen, MD., Ph.D.; Phone Number: 86-21-66111243; Email: weiym@smhc.org.cn

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • Tongji Hospital Affiliated with Tongji University
      • Contact: Shen Yuan PhD, PhD; Phone Number: +86 021 66111243; Email: weiym@smhc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexmedetomidine Group; 30 μg (one spray of 15 μg per nostril) administered intranasally. Completed within 2 minutes	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.
Placebo Comparator: Placebo Group; Equal-volume placebo (normal saline) administered intranasally, one spray per nostril	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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.
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	Baseline and at 15, 30, 45, 60, 90, and 120 minutes post-administration
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"	Baseline and at 15, 30, and 120 minutes post-administration
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	Baseline and at 15, 30, 45, 60, 90, and 120 minutes post-administration
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	Baseline and at 15, 30, 45, 60, 90, and 120 minutes post-administration

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tongji University
• Collaborators: Zhejiang University; Sir Run Run Shaw Hospital; Second Xiangya Hospital of Central South University; Huzhou Third People's Hospital; NINGBO KANGNING HOSPITAL; Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University; Shanghai Putuo District People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: April 19, 2026
• First Submitted That Met QC Criteria: April 19, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 6, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Dexmedetomidine
• Other Study ID Numbers: DEX-AAS-2601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data that underlie the results reported in the primary publication will be shared
• IPD Sharing Time Frame: Beginning 6 months and ending 36 months following article publication
• IPD Sharing Access Criteria: Data will be available to researchers who provide a methodologically sound proposal. Requests should be directed to the corresponding author
• IPD Sharing Supporting Information Type: ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No