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.
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Positive and Negative Symptom Scale Excited Component (PANSS-EC)
Timeframe: Measured at screening, prior to dosing, every 30 minutes post drug administration, and the day following drugadministration.
Skin conductance response (SCR)
Timeframe: Measured continuously from approximatley 15 minutes prior to drug administatration until the end of the test day (approximately 11 hours)
Heart rate variability
Timeframe: Measured continuously from approximatley 15 minutes prior to drug administatration until the end of the test day (approximately 11 hours)
Blood pressure
Timeframe: Measured at screening, prior to administartion, approximately every 15 minutes post drug administration, and one day after drug administration
Agitation-Calmness Scale (ACES)
Timeframe: Measured at screening, prior to administration, approximately every 30 minutes post dose, and one day following drug administration.
Richmond Agitation Sedation Scale (RASS)
Timeframe: Measured at screening, prior to administration, approximately every 30 minutes post dose, and one day following drug administration.