DexmedetomidineNCT07162649
Dexmedetomidine Nasal Spray for the Treatment of Panic Attacks in Adults
A study testing Dexmedetomidine in people with Dexmedetomidine and Panic Attacks, run by Tongji University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dexmedetomidine, Panic Attacks
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 26 Jun 2025to 5 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital Affiliated with Tongji University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Multicenter, Randomized, Controlled Clinical Trial to Evaluate the Efficacy and Safety of Dexmedetomidine Nasal Spray for the Treatment of Panic Attacks in Adults
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.
Read the 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, Panic Attacks
- Being tested
- Dexmedetomidine, Placebo
- Keywords
- Dexmedetomidine，Nasal spray
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
30μl
PlaceboDrug
30μl
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | 30μl Receives: Drug: Dexmedetomidine |
| Placebo | Placebo comparator | 30μl Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes post-administration
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline and 30 minutes post-administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start26 Jun 2025
- Primary completion5 Feb 2026
- Study completion5 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan Shen, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162649
- Sponsor's protocol ID
- dsyy001
- Status last verified
- Oct 2026
- First submitted
- 1 Sep 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Controlled Clinical Trial to Evaluate the Efficacy and Safety of Dexmedetomidine Nasal Spray for the Treatment of Panic Attacks in Adults
- ClinicalTrials.gov ID
- NCT07162649
- Acronym / sponsor ID
- dsyy001
- Conditions
- Dexmedetomidine, Panic Attacks
- Keywords
- Dexmedetomidine，Nasal spray
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- 5 Feb 2026 (actual)
- Study completion
- 5 Feb 2026 (actual)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine30μl |
| Placebo | Placebo comparator | Drug: Placebo30μl |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine30μl | Drug | Dexmedetomidine |
| Placebo30μl | Drug | Placebo |
Primary outcome
30-minute response rate using Clinical Global Impression-Efficacy Index (CGI-EI)
Time frame: 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.
2 secondary outcomes
Change in core panic symptom count
Time frame: Baseline and 30 minutes post-administration
Change in Visual Analogue Scale for Anxiety (VAS-A) score
Time frame: Baseline and 30 minutes post-administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Dexmedetomidine and Panic Attacks, run by Tongji University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-minute response rate using Clinical Global Impression-Efficacy Index (CGI-EI) (time frame: 30 minutes post-administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.