Intranasal Dexmedetomidine for Acute Anxiety State in Adults

NCT07550881 | Not Yet Recruiting Phase 2

• 1 other identifier: DEX-AAS-2601
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Anxiety States

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Proportion of patients with a CGI-I score≤ 2 at multiple time points

  30, 45, 60, 90, and 120 minutes post-administration

• Change in Clinical Global Impression - Severity (CGI-S) scores

  Baseline and at 15, 30, 45, 60, 90, and 120 minutes post-administration

• Change in STAI-S-6 scale scores

  Baseline and at 15, 30, and 120 minutes post-administration

• Change from baseline in the count of concomitant symptoms

  Baseline and at 15, 30, and 120 minutes post-administration.

• Change from baseline in the Numerical Rating Scale (NRS) score for subjective anxiety severity

  Baseline and at 15, 30, 45, 60, 90, and 120 minutes post-administration

Other Outcomes (1)

• Exploratory Endpoints：Changes in peripheral blood levels of biomarkers

  Baseline (pre-administration) and at 90-120 minutes post-administration

Study Arms (2)

Dexmedetomidine Group

ACTIVE COMPARATOR

30 μg (one spray of 15 μg per nostril) administered intranasally. Completed within 2 minutes

Drug: Dexmedetomidine

Placebo Group

PLACEBO COMPARATOR

Equal-volume placebo (normal saline) administered intranasally, one spray per nostril

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

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.

Dexmedetomidine Group; Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• NINGBO KANGNING HOSPITAL: collaborator
• Shanghai Pudong New Area Mental Health Center: collaborator
• Shanghai Putuo District People's Hospital: collaborator
• Tongji University: lead
• Second Xiangya Hospital of Central South University: collaborator
• Sir Run Run Shaw Hospital: collaborator
• Zhejiang University: collaborator
• Huzhou Third People's Hospital: collaborator

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Yuan Shen, MD., Ph.D.

CONTACT

86-21-66111243; weiym@smhc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: multicenter, randomized, double-blind, placebo-controlled, parallel-group superiority study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD., Ph.D.

Study Record Dates

• First Submitted: April 19, 2026
• First Posted: April 24, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR
• Time Frame: Beginning 6 months and ending 36 months following article publication
• Access Criteria: Data will be available to researchers who provide a methodologically sound proposal. Requests should be directed to the corresponding author