Tongji Hospital Affiliated with Tongji University
Shanghai, Shanghai Municipality, 200032, China
Location status: Recruiting
NCT Number: NCT07550881
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 2
Shanghai, Shanghai Municipality, 200032, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Time frame: 30, 45, 60, 90, and 120 minutes post-administration
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: Baseline and at 15, 30, 45, 60, 90, and 120 minutes post-administration
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, and 120 minutes post-administration
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.
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, 45, 60, 90, and 120 minutes post-administration
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, and 120 minutes post-administration
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, 45, 60, 90, and 120 minutes post-administration
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
Blood pressure is measured in mmHg. Both systolic and diastolic values will be recorded to evaluate hemodynamic stability
Time frame: Baseline (pre-administration) and at 90-120 minutes post-administration
Measurement of norepinephrine (NE), cortisol, and inflammatory cytokines (e.g., IL-6). These serve as physiological markers of stress and treatment response
Contact information is provided by the study sponsor or research team.
Tongji University
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.