Acute Anxiety States
Conditions
Brief 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. 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.
Interventions
DRUGDexmedetomidine
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.
Sponsors
Tongji University
Second Xiangya Hospital of Central South University
Sir Run Run Shaw Hospital
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 design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
multicenter, randomized, double-blind, placebo-controlled, parallel-group superiority study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. No gender restrictions; during screening: age must be between 18 and 65 years; 2. 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; 3. Voluntarily participate in this study and sign an informed consent form.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with a CGI-I score≤ 2. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with a CGI-I score≤ 2 at multiple time points | 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 |
| Change in Clinical Global Impression - Severity (CGI-S) scores | 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 |
| Change in STAI-S-6 scale scores | 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 |
| Change from baseline in the count of concomitant symptoms | 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 |
| Change from baseline in the Numerical Rating Scale (NRS) score for subjective anxiety severity | 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 |
| Change from baseline in the Richmond Agitation-Sedation Scale (RASS) score | 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" |
| Change from baseline in heart rate | 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 |
| Change from baseline in systolic and diastolic blood pressure | 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 |
Countries
China
Contacts
CONTACTYuan Shen, MD., Ph.D.
Outcome results
None listed