Intranasal Dexmedetomidine for Acute Anxiety State in Adults

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTongji University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine

    Drug

    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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Dexmedetomidine GroupActive comparator 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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.

Other outcomes

1

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

Sponsors and contacts

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Tongji University

Lead sponsor

Second Xiangya Hospital of Central South University

Collaborator

Sir Run Run Shaw Hospital

Collaborator

Zhejiang University

Collaborator

Huzhou Third People's Hospital

Collaborator

NINGBO KANGNING HOSPITAL

Collaborator

Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University

Collaborator

Shanghai Putuo District People's Hospital

Collaborator