Status:
NOT_YET_RECRUITING
Dexmedetomidine Nasal Spray for the Treatment of Panic Attacks in Adults
Lead Sponsor:
Yuan Shen
Collaborating Sponsors:
Shanghai 10th People's Hospital
Conditions:
Dexmedetomidine
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 m...
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 m...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2028
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT07162649
Start Date
September 1 2025
End Date
August 30 2028
Last Update
September 9 2025
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