A Multicenter, Randomized, Controlled Clinical Trial to Evaluate the Efficacy and Safety of Dexmedetomidine Nasal Spray for the Treatment of Panic Attacks in Adults
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 400
- 主要终点
- 30-minute response rate using Clinical Global Impression-Efficacy Index (CGI-EI)
研究概览
简要总结
Panic attacks affect 13.2% of adults globally, with acute treatments (e.g., benzodiazepines) carrying dependency risks. Dexmedetomidine, an α₂-adrenergic agonist, achieves peak plasma levels in 5-15 min via nasal delivery and may offer rapid, non-invasive relief for acute panic attacks. Despite preclinical evidence of anxiolytic effects, no randomized trials have evaluated its efficacy for panic attacks.
详细描述
Panic attacks affect 13.2% of adults globally, with acute treatments (e.g., benzodiazepines) carrying dependency risks. Dexmedetomidine, an α₂-adrenergic agonist, achieves peak plasma levels in 5-15 min via nasal delivery and may offer rapid, non-invasive relief for acute panic attacks. Despite preclinical evidence of anxiolytic effects, no randomized trials have evaluated its efficacy for panic attacks.
This randomized, double-blind, placebo-controlled trial will enroll 400 adults (18-65 years) with DSM-5-defined panic attacks from emergency/outpatient settings. Participants will be randomized 1:1 to dexmedetomidine (30 μg) or placebo nasal spray. The primary outcome is the 30-min response rate (defined as CGI-Efficacy Index >1.0). Secondary outcomes include reduction in core symptom count, anxiety severity (VAS-A), and safety assessments (vital signs, ECG, adverse events). Outcomes will be assessed at baseline, 30 min post-dose, and via telephone follow-ups on Days 7 and 14.
This first RCT of nasal dexmedetomidine for acute panic attacks addresses a critical gap in rapid and non-addictive interventions. It could offer a novel therapeutic option for panic attack patients refractory to first-line treatments.
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)
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
- •Written informed consent is provided after full explanation of objectives, procedures, potential benefits, and risks, with agreement to comply with study requirements.
- •Age between 18 and 65 years at screening.
- •Meet the DSM-5 diagnostic criteria for panic attacks (PA), including but not limited to those occurring in the context of post-traumatic stress disorder, acute stress disorder, generalized anxiety disorder, or social anxiety disorder. At baseline, a Clinical Global Impression-Severity of Illness (CGI-SI) score ≥ 4 is required.
- •Experience an average of ≥2 panic attacks daily during the week preceding enrollment.
排除标准
- •History of panic attacks induced by other psychoactive substances; or prior history of substance abuse involving psychiatric or anesthetic drugs.
- •Use of benzodiazepines, 5-HT1A receptor agonists, or other anxiolytics within 4 hours before enrollment.
- •General anesthesia within the past 28 days.
- •Known hypersensitivity to dexmedetomidine or any component of the investigational product.
- •Myocardial infarction or unstable angina within 6 months; heart rate <60 bpm at screening; history of severe arrhythmias (e.g., Type II second-degree or higher atrioventricular block) or cardiac insufficiency.
- •History of ischemic stroke or transient ischemic attack; uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg) or hypotension (SBP < 90 mmHg and/or DBP ≤ 50 mmHg) despite treatment.
- •Coagulation abnormalities: PT > ULN + 3 s and/or APTT > ULN + 10 s.
- •Significant airway obstruction (e.g., obstructive sleep apnea syndrome, asthma); or use of α2-adrenergic receptor agonists/antagonists within 14 days.
- •Abnormal liver function (ALT/AST >2×ULN or total bilirubin >1.5×ULN) or renal dysfunction (serum creatinine >1.5×ULN).
- •History of cognitive impairment or epilepsy.
- •Pregnant or breastfeeding; or women of childbearing potential unwilling/unable to use effective contraception from 30 days before screening through 6 months after study completion.
- •Any other condition deemed unsuitable by the investigator.
研究组 & 干预措施
Dexmedetomidine
30μl
干预措施: Dexmedetomidine (Drug)
Placebo
30μl
干预措施: Placebo (Drug)
结局指标
主要结局
30-minute response rate using Clinical Global Impression-Efficacy Index (CGI-EI)
时间窗: 30 minutes post-administration
Proportion of participants achieving a CGI-Efficacy Index \>1.0 at 30 minutes post-dose, indicating clinically significant symptom improvement. CGI-EI is a validated clinician-rated scale assessing therapeutic effect relative to side effects.
30-minute response rate using Clinical Global Impression-Efficacy Index (CGI-EI)
时间窗: 30 minutes post-administration
Proportion of participants achieving a CGI-Efficacy Index \>1.0 at 30 minutes post-dose, indicating clinically significant symptom improvement. CGI-EI is a validated clinician-rated scale assessing therapeutic effect relative to side effects.
次要结局
- Change in Visual Analogue Scale for Anxiety (VAS-A) score(Baseline and 30 minutes post-administration)
- Change in core panic symptom count(Baseline and 30 minutes post-administration)
- Change in Visual Analogue Scale for Anxiety (VAS-A) score(Baseline and 30 minutes post-administration)
研究者
Yuan Shen
MD., Ph.D.
Tongji University