NCT05658510

Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)

Efficacy And Safety of BXCL501 Evaluated For At-Home Use In A Multisite Double-Blind Placebo-Controlled Trial For Agitation Associated With Schizophrenia And Bipolar Disorder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 452 (actual)
• Sponsor: BioXcel Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

In this study, an investigational medication named BXCL501 is being tested for the treatment of episodes of agitation associated with bipolar I and bipolar II disorder, schizophrenia, schizoaffective and schizophreniform disorder. This study compares the study drug to a placebo.

Detailed description

This is a randomized, double-blind, placebo-controlled, 2-Part, Phase III study to assess the efficacy, safety, and tolerability of BXCL501 in adult (18-75 years old) males and females with agitation episodes associated with a primary diagnosis of bipolar I disorder, bipolar II disorder, schizophrenia, schizoaffective disorder, or schizophreniform disorder. Part 1 of the study is a one-day, in-clinic treatment of 60 mcg dose, and post-treatment observation period with patients experiencing an acute episode of agitation. Part 1 is now complete. Part 2 of the study is a 12-week study to determine the safety of a BXCL501 120 mcg dose when used as needed for episodes of agitation at home.

Conditions

• Agitation,Psychomotor
• Bipolar I Disorder
• Bipolar II Disorder
• Schizophrenia
• Schizoaffective Disorder
• Schizophreniform Disorders

Interventions

Type	Name	Description
DRUG	BXCL501	Sublingual Film
DRUG	Matching Placebo	Sublingual Placebo Film

Timeline

• Start date: 2022-11-21
• Primary completion: 2025-08-15
• Completion: 2025-08-15
• First posted: 2022-12-20
• Last updated: 2025-09-18

Locations

24 sites across 1 country: United States

Regulatory

• FDA-regulated drug study