Acute Anxiety StatesPhase 2NCT07550881
Intranasal Dexmedetomidine for Acute Anxiety State in Adults
A Phase 2 study testing Dexmedetomidine in people with Acute Anxiety States, run by Tongji University at 1 site in China.
Trial summary
This study employs a randomized, double-blind, placebo-controlled clinical trial design to evaluate the efficacy and safety of dexmedetomidine hydrochloride nasal spray in the treatment of acute anxiety in adults. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Anxiety States
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2026to 31 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- No gender restrictions; during screening: age must be between 18 and 65 years;
- Meet the criteria for acute anxiety, defined as subjective anxiety or worry accompanied by at least four associated symptoms, with a CGI-S score of ≥4;
- Voluntarily participate in this study and sign an informed consent form.
Who cannot join
- 1. Acute anxiety states caused by other psychoactive substances; history of abuse of psychotropic or anesthetic drugs; 2. Use of sedative-hypnotic drugs at the time of enrollment and still in the washout period; 3. Use of alpha-adrenergic agonists (e.g., norepinephrine, methoxamine, methoxamine hydrochloride, epinephrine, clonidine hydrochloride tablets, midodrine hydrochloride tablets, etc.) or beta-blockers (e.g., metoprolol, etc.) within the past 12 hours; 4. Patients with allergies to the active ingredients or components of the study drugs (e.g., dexmedetomidine) or those with a history of three or more allergic reactions to various allergens; 5. Endocrine system disorders, such as hypoglycemia, pheochromocytoma, hyperthyroidism, or hypothyroidism; 6. Cardiovascular diseases, including myocardial infarction or unstable angina within the 6 months prior to screening; heart rate <60 beats per minute during screening; History of severe arrhythmias, such as second-degree type II atrioventricular block or higher; poorly controlled blood pressure (hypertension: systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg, or hypotension: systolic blood pressure <90 mmHg and/or diastolic blood pressure ≤50 mmHg); 7. Cerebrovascular diseases, such as a history of ischemic stroke or transient ischemic attack; 8. Respiratory diseases, such as asthma, pulmonary embolism, chronic obstructive pulmonary disease, or pneumonia; history of difficult airway management or assessed potential risk, such as obstructive sleep apnea syndrome or asthma; 9. History of severe hepatic or renal insufficiency; 10. History of epilepsy; 11. Pregnant or lactating women; 12. Other conditions deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital Affiliated with Tongji University
Shanghai, Shanghai Municipality, 200032
Shen Yuan PhD, PhD, +86 021 66111243, weiym@smhc.org.cn
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating the Efficacy and Safety of Dexmedetomidine Hydrochloride Nasal Spray for the Treatment of Acute Anxiety States in Adults
This study employs a randomized, double-blind, placebo-controlled clinical trial design to evaluate the efficacy and safety of dexmedetomidine hydrochloride nasal spray in the treatment of acute anxiety in adults.
Study Protocol: Patients meeting the criteria for acute anxiety who provided informed consent and met the inclusion and exclusion criteria were randomized in a 1:1 ratio to the placebo group or the study drug group and entered the double-blind study. Upon enrollment, baseline assessments were conducted to evaluate the number of accompanying symptoms, subjective anxiety severity (NRS), STAI-S-6, CGI-S, and RASS. Immediately following these assessments, patients received a nasal spray of 30 μg of dexmedetomidine or an equal-volume placebo; the time of administration was recorded as 0 minutes. At 15, 30, 45, 60, 90, and 120 minutes post-administration, the NRS for subjective anxiety severity, CGI-S, and CGI-I were assessed. The count of accompanying symptoms, STAI-S-6, and RASS were re-assessed only at 15, 30, and 120 minutes post-administration. In addition, vital signs (heart rate, oxygen saturation, and blood pressure) were assessed and recorded at baseline (prior to administration) and at 15, 30, 45, 60, 90, and 120 minutes post-administration. Venous blood samples were collected prior to administration and 90-120 minutes post-administration to measure biological markers. Adverse events were monitored during a 7-day follow-up period after treatment.
- Conditions
- Acute Anxiety States
- Being tested
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Patients meeting the criteria for acute anxiety who provided informed consent and met the inclusion and exclusion criteria were randomized in a 1:1 ratio to the placebo group or the study drug group and entered the double-blind study.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group | Active comparator | 30 μg (one spray of 15 μg per nostril) administered intranasally. Completed within 2 minutes Receives: Drug: Dexmedetomidine |
| Placebo Group | Placebo comparator | Equal-volume placebo (normal saline) administered intranasally, one spray per nostril Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a CGI-I score≤ 2.
The Clinical Global Impression - Improvement (CGI-I) scale is used to assess how much the patient's illness has improved or worsened relative to a baseline state. A score of 1 (Very Much Improved) or 2 (Much Improved) indicates a significant clinical response
Measured: 15 minutes post-administration
Secondary outcomes (8)
Proportion of patients with a CGI-I score≤ 2 at multiple time points
CGI-I ranges from 1 (normal) to 7 (among the most extremely ill patients). This measure assesses the change in severity from baseline
Measured: 30, 45, 60, 90, and 120 minutes post-administration
Change in Clinical Global Impression - Severity (CGI-S) scores
CGI-S ranges from 1 (normal) to 7 (among the most extremely ill patients). This measure assesses the change in severity from baseline
Measured: Baseline and at 15, 30, 45, 60, 90, and 120 minutes post-administration
Change in STAI-S-6 scale scores
The 6-item State-Trait Anxiety Inventory (STAI-S-6) scores range from 6 to 24, with higher scores indicating more severe anxiety
Measured: Baseline and at 15, 30, and 120 minutes post-administration
Change from baseline in the count of concomitant symptoms
Based on DSM-5 criteria, 13 symptoms of acute anxiety are assessed (e.g., palpitations, sweating, trembling). The investigator counts the number of symptoms present. A decrease in count indicates symptomatic relief
Measured: Baseline and at 15, 30, and 120 minutes post-administration.
Change from baseline in the Numerical Rating Scale (NRS) score for subjective anxiety severity
Patients rate their current level of anxiety on a scale of 0 to 10, where 0 is "not at all" and 10 is "the most severe". A higher score represents more severe anxiet
Measured: Baseline and at 15, 30, 45, 60, 90, and 120 minutes post-administration
Change from baseline in the Richmond Agitation-Sedation Scale (RASS) score
The RASS is used to assess the level of alertness and agitation. Scores range from +4 (combative) to -5 (unarousable), with 0 being "alert and calm"
Measured: Baseline and at 15, 30, and 120 minutes post-administration
Change from baseline in heart rate
Heart rate is measured in beats per minute (bpm) to monitor the drug's effect on autonomic activity and safety
Measured: Baseline and at 15, 30, 45, 60, 90, and 120 minutes post-administration
Change from baseline in systolic and diastolic blood pressure
Blood pressure is measured in mmHg. Both systolic and diastolic values will be recorded to evaluate hemodynamic stability
Measured: Baseline and at 15, 30, 45, 60, 90, and 120 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 posted24 Apr 2026
- Study start30 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Anxiety StatesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji University
- Sponsor type
- University, hospital or other
- Collaborators
- Second Xiangya Hospital of Central South University, Sir Run Run Shaw Hospital, First Affiliated Hospital of Zhejiang University, Huzhou Third People's Hospital, NINGBO KANGNING HOSPITAL, Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University, Shanghai Putuo District People's Hospital
- Responsible party
- Principal investigator, Yuan Shen, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550881
- Sponsor's protocol ID
- DEX-AAS-2601
- Status last verified
- Jun 2026
- First submitted
- 19 Apr 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in the primary publication will be shared
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Evaluating the Efficacy and Safety of Dexmedetomidine Hydrochloride Nasal Spray for the Treatment of Acute Anxiety States in Adults
- ClinicalTrials.gov ID
- NCT07550881
- Acronym / sponsor ID
- DEX-AAS-2601
- Conditions
- Acute Anxiety States
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Collaborators
- Second Xiangya Hospital of Central South University, Sir Run Run Shaw Hospital, First Affiliated Hospital of Zhejiang University, Huzhou Third People's Hospital, NINGBO KANGNING HOSPITAL, Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University, Shanghai Putuo District People's Hospital
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 24 Apr 2026 (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.
This study employs a randomized, double-blind, placebo-controlled clinical trial design to evaluate the efficacy and safety of dexmedetomidine hydrochloride nasal spray in the treatment of acute anxiety in adults.
Study Protocol: Patients meeting the criteria for acute anxiety who provided informed consent and met the inclusion and exclusion criteria were randomized in a 1:1 ratio to the placebo group or the study drug group and entered the double-blind study. Upon enrollment, baseline assessments were conducted to evaluate the number of accompanying symptoms, subjective anxiety severity (NRS), STAI-S-6, CGI-S, and RASS. Immediately following these assessments, patients received a nasal spray of 30 μg of dexmedetomidine or an equal-volume placebo; the time of administration was recorded as 0 minutes. At 15, 30, 45, 60, 90, and 120 minutes post-administration, the NRS for subjective anxiety severity, CGI-S, and CGI-I were assessed. The count of accompanying symptoms, STAI-S-6, and RASS were re-assessed only at 15, 30, and 120 minutes post-administration. In addition, vital signs (heart rate, oxygen saturation, and blood pressure) were assessed and recorded at baseline (prior to administration) and at 15, 30, 45, 60, 90, and 120 minutes post-administration. Venous blood samples were collected prior to administration and 90-120 minutes post-administration to measure biological markers. Adverse events were monitored during a 7-day follow-up period after treatment.
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 Group | Active comparator | Drug: Dexmedetomidine30 μg (one spray of 15 μg per nostril) administered intranasally. Completed within 2 minutes |
| Placebo Group | Placebo comparator | Drug: DexmedetomidineEqual-volume placebo (normal saline) administered intranasally, one spray per nostril |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- No gender restrictions; during screening: age must be between 18 and 65 years;
- Meet the criteria for acute anxiety, defined as subjective anxiety or worry accompanied by at least four associated symptoms, with a CGI-S score of ≥4;
- Voluntarily participate in this study and sign an informed consent form.
Key exclusion criteria (1 listed)
- 1. Acute anxiety states caused by other psychoactive substances; history of abuse of psychotropic or anesthetic drugs; 2. Use of sedative-hypnotic drugs at the time of enrollment and still in the washout period; 3. Use of alpha-adrenergic agonists (e.g., norepinephrine, methoxamine, methoxamine hydrochloride, epinephrine, clonidine hydrochloride tablets, midodrine hydrochloride tablets, etc.) or beta-blockers (e.g., metoprolol, etc.) within the past 12 hours; 4. Patients with allergies to the active ingredients or components of the study drugs (e.g., dexmedetomidine) or those with a history of three or more allergic reactions to various allergens; 5. Endocrine system disorders, such as hypoglycemia, pheochromocytoma, hyperthyroidism, or hypothyroidism; 6. Cardiovascular diseases, including myocardial infarction or unstable angina within the 6 months prior to screening; heart rate <60 beats per minute during screening; History of severe arrhythmias, such as second-degree type II atrioventricular block or higher; poorly controlled blood pressure (hypertension: systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg, or hypotension: systolic blood pressure <90 mmHg and/or diastolic blood pressure ≤50 mmHg); 7. Cerebrovascular diseases, such as a history of ischemic stroke or transient ischemic attack; 8. Respiratory diseases, such as asthma, pulmonary embolism, chronic obstructive pulmonary disease, or pneumonia; history of difficult airway management or assessed potential risk, such as obstructive sleep apnea syndrome or asthma; 9. History of severe hepatic or renal insufficiency; 10. History of epilepsy; 11. Pregnant or lactating women; 12. Other conditions deemed unsuitable for enrollment by the investigator.
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 |
|---|---|---|
| DexmedetomidinePatients meeting the criteria for acute anxiety who provided informed consent and met the inclusion and exclusion criteria were randomized in a 1:1 ratio to the placebo group or the study drug group and entered the double-blind study. | Drug | Dexmedetomidine Group, Placebo Group |
Primary outcome
Proportion of patients with a CGI-I score≤ 2.
Time frame: 15 minutes post-administration
The Clinical Global Impression - Improvement (CGI-I) scale is used to assess how much the patient's illness has improved or worsened relative to a baseline state. A score of 1 (Very Much Improved) or 2 (Much Improved) indicates a significant clinical response
8 secondary outcomes
Proportion of patients with a CGI-I score≤ 2 at multiple time points
Time frame: 30, 45, 60, 90, and 120 minutes post-administration
Change in Clinical Global Impression - Severity (CGI-S) scores
Time frame: Baseline and at 15, 30, 45, 60, 90, and 120 minutes post-administration
Change in STAI-S-6 scale scores
Time frame: Baseline and at 15, 30, and 120 minutes post-administration
Change from baseline in the count of concomitant symptoms
Time frame: Baseline and at 15, 30, and 120 minutes post-administration.
Change from baseline in the Numerical Rating Scale (NRS) score for subjective anxiety severity
Time frame: Baseline and at 15, 30, 45, 60, 90, and 120 minutes post-administration
Change from baseline in the Richmond Agitation-Sedation Scale (RASS) score
Time frame: Baseline and at 15, 30, and 120 minutes post-administration
Change from baseline in heart rate
Time frame: Baseline and at 15, 30, 45, 60, 90, and 120 minutes post-administration
Change from baseline in systolic and diastolic blood pressure
Time frame: Baseline and at 15, 30, 45, 60, 90, and 120 minutes post-administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in the primary publication will be shared
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexmedetomidine in people with Acute Anxiety States, 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 10 Jun 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuan Shen, MD., Ph.D. (86-21-66111243, weiym@smhc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a CGI-I score≤ 2. (time frame: 15 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 10 Jun 2026.