Status:
NOT_YET_RECRUITING
Pilot Study 1: Efficacy and Safety of Sublingual Dexmedetomidine (BXCL501) for the Treatment of Agitation in the Emergency Department
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Agitation
Schizophrenia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 patien...
Detailed Description
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...
Eligibility Criteria
Inclusion
- English speaking adults age ≥18 years
- Patients with an established diagnosis of (1) bipolar I disorder, (2) bipolar II disorder, (3) schizophrenia, (4) schizoaffective disorder, or (5) schizophreniform disorder
- Judged to be clinically agitated at the time of Screening and Baseline with a AMSS ≥2
- Able to read, understand, and provide written informed consent
- Subject judged to be likely capable of self-administration of BXCL501 sublingually or buccally
Exclusion
- Likely to be discharged, admitted, or transferred from the ED within 6 hours after study medication administration
- Administration of benzodiazepines or antipsychotic drugs in the 2 hours before study treatment
- Treatment with alpha-1 noradrenergic antagonists
- Female patients who are pregnant or are breastfeeding
- Hypotension (systolic blood pressure \<100 mmHg or diastolic blood pressure \<60 mmHg) and/or bradycardia (heart rate \<55 beats per minute) at the time of Screening or Baseline evaluation
- History of dysautonomia
- Patient with a known diagnosis of familial long QT syndrome, second degree or third degree atrioventricular block without pacemaker, or sick sinus syndrome
- Patients with serious or unstable medical illnesses determined by the study investigators or qualified designees
- Patients with history of allergic reactions to dexmedetomidine
- Patients previously enrolled and completed the current study
- Patients actively enrolled in other ED-based studies involving pharmacological or behavioral interventions
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05974527
Start Date
September 1 2023
End Date
June 30 2026
Last Update
August 3 2023
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