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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Proportion of patients with a CGI-I score≤ 2.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
multicenter, randomized, double-blind, placebo-controlled, parallel-group superiority study
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •1. Acute anxiety states caused by other psychoactive substances; history of abuse of psychotropic or anesthetic drugs;
- •Use of sedative-hypnotic drugs at the time of enrollment and still in the washout period;
- •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;
- •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;
- •Endocrine system disorders, such as hypoglycemia, pheochromocytoma, hyperthyroidism, or hypothyroidism;
- •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);
- •Cerebrovascular diseases, such as a history of ischemic stroke or transient ischemic attack;
- •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;
- •History of severe hepatic or renal insufficiency;
- •History of epilepsy;
- •Pregnant or lactating women;
- •Other conditions deemed unsuitable for enrollment by the investigator.
研究组 & 干预措施
Placebo Group
Equal-volume placebo (normal saline) administered intranasally, one spray per nostril
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine Group
30 μg (one spray of 15 μg per nostril) administered intranasally. Completed within 2 minutes
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Proportion of patients with a CGI-I score≤ 2.
时间窗: 15 minutes post-administration
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
次要结局
- 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)
- Change from baseline in the Richmond Agitation-Sedation Scale (RASS) score(Baseline and at 15, 30, and 120 minutes post-administration)
- Change from baseline in heart rate(Baseline and at 15, 30, 45, 60, 90, and 120 minutes post-administration)
- Change from baseline in systolic and diastolic blood pressure(Baseline and at 15, 30, 45, 60, 90, and 120 minutes post-administration)
研究者
Yuan Shen
MD., Ph.D.
Tongji University