Poster
161
(#161) An open-label, randomized, active controlled trial evaluating sublingual dexmedetomidine for moderate to severe agitation in patients with schizophrenia or bipolar disorder
Psych Congress 2025
Abstract: Agitation is a common problem associated with psychiatric disorders. Sublingual dexmedetomidine is FDA approved for the treatment of agitation associated with schizophrenia and bipolar disorder. Sublingual administration avoids the need for invasive injections while still yielding a rapid onset-of-action. We aimed to evaluate the efficacy and tolerability of sublingual dexmedetomidine compared to oral lorazepam for the treatment of agitation in real-world patients with schizophrenia, schizoaffective, or bipolar disorder, as measured by the Positive and Negative Syndrome Scale-Exited Component (PANSS-EC).
We conducted an open label, randomized, non-blinded, active control trial. Patients 18-55 years old admitted to an inpatient psychiatry unit with PANNS-EC ≥14 were included. Patients received sublingual dexmedetomidine (120mcg for PEC ≥14 and 180mcg for PEC ≥20) or oral lorazepam 2mg. The PANSS-EC was then administered 15, 30, 60, 90 and 120 minutes after initial medication administration.
24 patients were randomized to sublingual dexmedetomidine 180mcg (n=7), dexmedetomidine 120mcg (n=5) or lorazepam 2mg (n=12). At two hours post-dose, change from baseline in PANSS-EC total score were -12.7 (6.4) and -14.3 (4.3) for the sublingual dexmedetomidine and lorazepam groups, respectively (p = 0.71). There were no significant differences between PANSS-EC subscale items (excitement, hostility, tension, uncooperativeness, poor impulse control sign) (p = 0.24). There were no spontaneously reported adverse events or study dropouts attributed to tolerability.
The clinical trial data from our study indicates that sublingual dexmedetomidine is safe, effective, well tolerated and comparable to oral lorazepam for managing acute agitation on inpatient psychiatric units as measured by the PANSS-EC.
Short Description: Sublingual dexmedetomidine avoids the need for invasive parenteral injections while still yielding a rapid onset-of-action. We conducted an open label, randomized, non-blinded, active control trial in 24 psychiatric inpatients comparing sublingual dexmedetomidine 180mcg (n=7) and 120mcg (n=5) to oral lorazepam 2mg in patients with moderate to severe agitation as measured by the PANSS-EC. Sublingual dexmedetomidine was found to be safe, effective, well tolerated, and comparable to oral lorazepam for the management of acute agitation.
Name of Sponsoring Organization(s): N/A
We conducted an open label, randomized, non-blinded, active control trial. Patients 18-55 years old admitted to an inpatient psychiatry unit with PANNS-EC ≥14 were included. Patients received sublingual dexmedetomidine (120mcg for PEC ≥14 and 180mcg for PEC ≥20) or oral lorazepam 2mg. The PANSS-EC was then administered 15, 30, 60, 90 and 120 minutes after initial medication administration.
24 patients were randomized to sublingual dexmedetomidine 180mcg (n=7), dexmedetomidine 120mcg (n=5) or lorazepam 2mg (n=12). At two hours post-dose, change from baseline in PANSS-EC total score were -12.7 (6.4) and -14.3 (4.3) for the sublingual dexmedetomidine and lorazepam groups, respectively (p = 0.71). There were no significant differences between PANSS-EC subscale items (excitement, hostility, tension, uncooperativeness, poor impulse control sign) (p = 0.24). There were no spontaneously reported adverse events or study dropouts attributed to tolerability.
The clinical trial data from our study indicates that sublingual dexmedetomidine is safe, effective, well tolerated and comparable to oral lorazepam for managing acute agitation on inpatient psychiatric units as measured by the PANSS-EC.
Short Description: Sublingual dexmedetomidine avoids the need for invasive parenteral injections while still yielding a rapid onset-of-action. We conducted an open label, randomized, non-blinded, active control trial in 24 psychiatric inpatients comparing sublingual dexmedetomidine 180mcg (n=7) and 120mcg (n=5) to oral lorazepam 2mg in patients with moderate to severe agitation as measured by the PANSS-EC. Sublingual dexmedetomidine was found to be safe, effective, well tolerated, and comparable to oral lorazepam for the management of acute agitation.
Name of Sponsoring Organization(s): N/A
