NCT07162649

Dexmedetomidine Nasal Spray for the Treatment of Panic Attacks in Adults

A Multicenter, Randomized, Controlled Clinical Trial to Evaluate the Efficacy and Safety of Dexmedetomidine Nasal Spray for the Treatment of Panic Attacks in Adults

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Yuan Shen · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Dexmedetomidine

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	30μl
DRUG	Placebo	30μl

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-08-30
• Completion: 2028-08-30
• First posted: 2025-09-09
• Last updated: 2025-09-09