Sublingual dexmedetomidine beneficial against severe agitation in bipolar disorders: JAMA

USA: A new study shows that an application of a sublingual film formulation of dexmedetomidine 120 g or 180 g, compared to placebo, resulted in a substantially higher decrease in the agitation score at 2 hours in patients with mild to severe agitation associated with bipolar disorder. The findings of this study were published in the Journal of American Medical Association.

Acute agitation is prevalent in bipolar disorder patients and needs immediate treatment to ease discomfort and prevent escalation to violent conduct. This study was carried out by Sheldon H. Preskorn and colleagues to assess the effect of orally absorbed, sublingual dexmedetomidine, a selective α2A-adrenergic receptor agonist, on symptoms of acute agitation in individuals with bipolar disorder.

This Phase 3 randomized, double-blind, placebo-controlled study was conducted at 15 sites across the United States, with enrolment taking place between February 24, 2020, and April 27, 2020, with the final follow-up taking place on May 21, 2020. A total of 380 persons with bipolar I or II illness were randomly assigned to the trial, with 362 completing it. Participants were randomly assigned to one of three groups: 180 g sublingual dexmedetomidine (n = 127), 120 g sublingual dexmedetomidine (n = 127), or placebo (n = 126). The primary effectiveness end goal was the mean difference from baseline in the Positive and Negative Syndrome Scale-Excited Component (PEC) total score at 2 hours. The secondary endpoint was the earliest period when the medication vs placebo caused a statistically significant change in PEC total score from baseline.