A Phase 4 interventional study of Sublingual film containing dexmedetomidine (BXCL501) in Agitation, Schizophrenia and Schizoaffective Disorder, sponsored by Brigham and Women's Hospital. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by Brigham and Women's Hospital · Phase 4, Interventional, and Treatment
This is a single-arm pilot study to examine the impact of BXCL501 (sublingual film formulation of dexmedetomidine) administration on reducing the severity of undifferentiated acute agitation in patients presenting to the emergency department with underlying bipolar disorder or schizophrenia. This study is designed to evaluate BXCL501 for its FDA-approved indication -- treatment of agitation associated with bipolar disorder or schizophrenia -- applied in the emergency department setting.
This pilot study will enroll 30 male and female adults with primary psychiatric complaint and a documented diagnosis of bipolar I disorder, bipolar II disorder, schizophrenia, schizoaffective disorder, or schizophreniform disorder, presenting to the emergency department with clinical signs of acute agitation. Eligible subjects will receive an initial dose of BXCL501 (180mcg) and a repeat dose (90mcg) 2 hours after the first BXCL501 dose in the event of persistent or recurrent agitation (up to two repeat doses) while under medical supervision in the emergency department. Efficacy and safety assessments will be conducted periodically before and after dosing.
500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.
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Exclusion Criteria:
Drug: Sublingual film containing dexmedetomidine (BXCL501)
Enrolled participants will receive an initial dose of BXCL501 180mcg. Following the FDA dosing suggestions, participants with mild or moderate hepatic impairment (Child-Pugh Class A or B) will receive a reduced initial dose of 120mcg and participants with severe hepatic impairment (Child-Pugh Class C) will receive a reduced initial dose of 90mcg. Geriatric patients (≥ 65 years old) will receive a reduced initial dose of 120mcg.
Absolute change from baseline in the Altered Mental Status Scale (AMSS) score
AMSS is a 9-point scale ranging from -4 (most sedated) to 4 (most agitated).
Time frame: 120 minutes
Absolute change from baseline in the Richmond Agitation Sedation Scale (RASS) score
RASS is a 10-point scale with four levels of anxiety or agitation (+1 to +4), one denoting a calm, alert state (0), and five levels of sedation (-1 to -5).
Time frame: 120 minutes
Absolute change from baseline in the Behavioral Activity Rating Scale (BARS) score
BARS is a 7-point scale ranging from 1 (difficult or unable to arouse) to 7 (violent, requires restraints).
Time frame: 120 minutes
Absolute change from baseline in the Broset Violence Checklist (BVC) score
BVC is a six-item instrument with a total score ranging from 0 (no agitation) to 6 (severely agitated).
Time frame: 120 minutes
Times, in minutes, from BXCL501 administration to adequate sedation, defined as Altered Mental Status Scale (AMSS) score <1
AMSS is a 9-point scale ranging from -4 (most sedated) to 4 (most agitated).
Time frame: To be determined - will be measured for 120 minutes
Times, in minutes, from BXCL501 administration to adequate sedation, defined as Richmond Agitation Sedation Scale (RASS) score <1
RASS is a 10-point scale with four levels of anxiety or agitation (+1 to +4), one denoting a calm, alert state (0), and five levels of sedation (-1 to -5).
Time frame: To be determined - will be measured for 120 minutes
Times, in minutes, from BXCL501 administration to adequate sedation, defined as Behavioral Activity Rating Scale (BARS) score <5
BARS is a 7-point scale ranging from 1 (difficult or unable to arouse) to 7 (violent, requires restraints).
Time frame: To be determined - will be measured for 120 minutes
Times, in minutes, from BXCL501 administration to adequate sedation, defined as Broset Violence Checklist (BVC) score <1
BVC is a six-item instrument with a total score ranging from 0 (no agitation) to 6 (severely agitated).
Time frame: To be determined - will be measured for 120 minutes
No study locations are listed for this record.
This study is withdrawn, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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