Intranasal Dexmedetomidine for Acute Anxiety State in Adults

Phase 2RecruitingNCT07550881

Tongji University150 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Acute Anxiety States

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 15 minutes post-administration

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

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

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

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

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"

Time frame: 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

Time frame: 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

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

Intranasal Dexmedetomidine for Acute Anxiety State in Adults

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts