Intranasal Dexmedetomidine for Acute Anxiety State 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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Proportion of patients with a CGI-I score≤ 2. [Time frame: 15 minutes post-administration]

Secondary outcome measures (8)

• Proportion of patients with a CGI-I score≤ 2 at multiple time points [Time frame: 30, 45, 60, 90, and 120 minutes post-administration]
• Change in Clinical Global Impression - Severity (CGI-S) scores [Time frame: Baseline and at 15, 30, 45, 60, 90, and 120 minutes post-administration]
• Change in STAI-S-6 scale scores [Time frame: Baseline and at 15, 30, and 120 minutes post-administration]
• Change from baseline in the count of concomitant symptoms [Time frame: Baseline and at 15, 30, and 120 minutes post-administration.]
• Change from baseline in the Numerical Rating Scale (NRS) score for subjective anxiety severity [Time frame: Baseline and at 15, 30, 45, 60, 90, and 120 minutes post-administration]
• Change from baseline in the Richmond Agitation-Sedation Scale (RASS) score [Time frame: Baseline and at 15, 30, and 120 minutes post-administration]
• Change from baseline in heart rate [Time frame: Baseline and at 15, 30, 45, 60, 90, and 120 minutes post-administration]
• Change from baseline in systolic and diastolic blood pressure [Time frame: Baseline and at 15, 30, 45, 60, 90, and 120 minutes post-administration]

Eligibility criteria

Inclusion criteria

• 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Tongji Hospital Affiliated with Tongji University — Shanghai

Identifiers

NCT: NCT07550881 · DEX-AAS-2601

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗