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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
400
30μl
30μl
30-minute response rate using Clinical Global Impression-Efficacy Index (CGI-EI)
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.
Time frame: 30 minutes post-administration
Change in core panic symptom count
Reduction in the number of DSM-5-defined core panic symptoms (e.g., palpitations, trembling, choking sensations) self-reported by participants at 30 minutes post-dose.
Time frame: Baseline and 30 minutes post-administration
Change in Visual Analogue Scale for Anxiety (VAS-A) score
Reduction in self-reported anxiety severity measured on a 0-10 VAS-A scale (0=no anxiety; 10=maximum anxiety) at 30 minutes post-dose.
Time frame: Baseline and 30 minutes post-administration
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