A Phase 2 interventional study of Dexmedetomidine in Acute Anxiety States, sponsored by Tongji University. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Tongji University · Phase 2, Interventional, and Treatment
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.
Tongji University is the lead sponsor of 40 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
30 μg (one spray of 15 μg per nostril) administered intranasally. Completed within 2 minutes
Drug: Dexmedetomidine
Equal-volume placebo (normal saline) administered intranasally, one spray per nostril
Drug: Dexmedetomidine
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.
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
Time frame: 15 minutes post-administration
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
Time frame: 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
Time frame: 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
Time frame: 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
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
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
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
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"
Time frame: 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
Time frame: 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
Time frame: Baseline and at 15, 30, 45, 60, 90, and 120 minutes post-administration
Exploratory Endpoints：Changes in peripheral blood levels of biomarkers
Measurement of norepinephrine (NE), cortisol, and inflammatory cytokines (e.g., IL-6). These serve as physiological markers of stress and treatment response
Time frame: Baseline (pre-administration) and at 90-120 minutes post-administration
Plan to share: Yes — De-identified individual participant data that underlie the results reported in the primary publication will be shared
Supporting information: Informed consent form, Clinical study report
Time frame: Beginning 6 months and ending 36 months following article publication
Access criteria: Data will be available to researchers who provide a methodologically sound proposal. Requests should be directed to the corresponding author
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Dec 2026, 8 months after the start.
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Studies of the drug tested here: Dexmedetomidine
Tongji University