Safety and Efficacy of BXCL501, a Sublingual Film Delivery of Dexmedetomidine for the Treatment of Acute Agitation in Schizophrenia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Blood pressure
研究概览
简要总结
Agitation is characterized by excessive motor or verbal activity, irritability, uncooperativeness, threatening gestures, and, in some cases, aggressive or violent behavior. While agitation may have various underlying causes, patients with schizophrenia are especially vulnerable to acute episodes of agitation, especially during exacerbation of disease, and clinicians do not always diagnose these episodes early enough. Agitation associated with psychosis is a frequent reason for emergency department visits, and unless it is recognized early and managed effectively, it can rapidly escalate to potentially dangerous behaviors, including physical violence. Educating psychiatric professionals about the timely and accurate diagnosis of agitation among patients with schizophrenia or bipolar disorder and developing a well-tolerated easily administered medication will contribute to the prompt and effective management of this condition and could help reduce the risk of violent behavior and other undesirable outcomes. This study is designed to identify the ideal dose range and tolerability of sublingual Dexmedetomidine in patients with schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to give informed consent.
- •Male or female between 18 and 65 years of age, inclusive
- •According to DSM-V meet criteria for Schizophrenia or Schizoaffective disorder.
排除标准
- •Current significant medical condition or other comorbidities
- •Current substance dependence
- •Women who are pregnant or breastfeeding
研究组 & 干预措施
Order 1
Subjects will be given a sublingual formulation of BXCL501 (dexmedetomidine)
干预措施: Dexmedetomidine Hydrochloride (Drug)
Order 2
Subjects will be given a sublingual film of placebo.
干预措施: Placebos (Drug)
结局指标
主要结局
Blood pressure
时间窗: Measured at screening, prior to administartion, approximately every 15 minutes post drug administration, and one day after drug administration
Systolic and diastolic blood pressure
Agitation-Calmness Scale (ACES)
时间窗: Measured at screening, prior to administration, approximately every 30 minutes post dose, and one day following drug administration.
Designed to assess the clinical levels of calmness and sedation. This is a 9-point scale that differentiates between agitation, calmness, and sleep states Scores range from 1 (marked agitation)-9 (unarousable).
Positive and Negative Symptom Scale Excited Component (PANSS-EC)
时间窗: Measured at screening, prior to dosing, every 30 minutes post drug administration, and the day following drugadministration.
PANSS-EC comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored from 1 (minimum) to 7 (maximum). The PANSS-EC is the sum of these 5 subscales and ranges from 5 to 35.
Skin conductance response (SCR)
时间窗: Measured continuously from approximatley 15 minutes prior to drug administatration until the end of the test day (approximately 11 hours)
SCR is one of the fastest-responding measures of stress response and arousal. Along with changes in heart rate, it has been found to be one of the most robust and non-invasive physiological measures of autonomic nervous system activity.
Heart rate variability
时间窗: Measured continuously from approximatley 15 minutes prior to drug administatration until the end of the test day (approximately 11 hours)
Heart rate variability (HRV) is a measure of the variability in time intervals between heart beats and is sensitive to sympathetic activity as well as worsening of psychosis/agitation.
Richmond Agitation Sedation Scale (RASS)
时间窗: Measured at screening, prior to administration, approximately every 30 minutes post dose, and one day following drug administration.
The RASS is a 10-level rating scale ranging from "Combative" (+4) to "unarousable" (-5).
次要结局
- Behavioral Activity Rating Scale (BARS)(Measured at screening, prior to administration, approximately every 30 minutes post dose, and one day following drug administration.)
- Clinical Global Impressions-Improvement Scale (CGI-I)(Measured at screening, prior to dosing, every 30 minutes post drug administration, and the day following drugadministration.)
- Adverse Effects(Assessed prior to dosing, throughout study drug administration, and up to one week after drug administration)