Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia

Summary

This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in schizophrenia. The BXCL501-301 study is designed to characterize the efficacy, safety and tolerability of BXCL501 (sublingual film formulation of DEX, HCl) in agitation associated with schizophrenia, schizoaffective disorder or schizophreniform disorder.

Timeline

Start

2020-01-24

Primary completion

2020-05-06

Completion

2020-05-06

Outcome

Met primary endpoint

registry analysis (superiority test); 180 Micrograms vs Placebo; p <0.0001; Mixed Models Analysis NCT04268303 ↗

registry analysis (superiority test); 120 Micrograms vs Placebo; p <0.0001; Mixed Models Analysis NCT04268303 ↗

Publications

• Citrome L, Preskorn SH, Lauriello J, Krystal JH, Kakar R, Finman J, De Vivo M, Yocca FD, Risinger R, Rajachandran L. Sublingual Dexmedetomidine for the Treatment of Acute Agitation in Adults With Schizophrenia or Schizoaffective Disorder: A Randomized Placebo-Controlled Trial. J Clin Psychiatry. 2022 Oct 3;83(6):22m14447. doi: 10.4088/JCP.22m14447.
• Citrome L, Risinger R, Rajachandran L, Robison H. Sublingual Dexmedetomidine for Agitation Associated with Schizophrenia or Bipolar Disorder: A Post Hoc Analysis of Number Needed to Treat, Number Needed to Harm, and Likelihood to be Helped or Harmed. Adv Ther. 2022 Oct;39(10):4821-4835. doi: 10.1007/s12325-022-02274-3. Epub 2022 Aug 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexmedetomidine	Other / unclassified	120 ug	Other
Subject	Dexmedetomidine	Other / unclassified	180 ug	Other

Indications