Dexmedetomidine Nasal Spray for the Treatment of Panic Attacks in Adults

NCT07162649 | Withdrawn

• 1 other identifier: dsyy001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• 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.

  30 minutes post-administration

Secondary Outcomes (2)

• 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

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  within 2 weeks post-dose

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

30μl

Drug: Dexmedetomidine

Placebo

PLACEBO COMPARATOR

30μl

Drug: Placebo

Interventions

Dexmedetomidine DRUG

30μl

Dexmedetomidine

Placebo DRUG

30μl

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: collaborator
• Tongji University: lead
• Shanghai Pudong New Area Mental Health Center: collaborator

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD., Ph.D.

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 9, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share