Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title: An Open-Label, Randomized, Active Controlled Inpatient Trial Evaluating Sublingual Dexmedetomidine For Moderate To Severe Agitation In Inpatients With Schizophrenia Or Bipolar Disorder

Status Recruiting

Clinical Trial Summary

An open-label, randomized, active control inpatient trial to evaluate the efficacy and tolerability of sublingual dexmedetomidine for the treatment of agitation in inpatients with schizophrenia or bipolar disorder as measured by the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) and Agitation-Calmness Evaluation Scale (ACES). Lorazepam will serve as the active control.

Clinical Trial Description

This is an open-label, randomized control trial where patients (N=32) with schizophrenia or bipolar disorder are randomized to receive either sublingual dexmedetomidine or oral lorazepam monotherapy for the treatment of episodic agitation. For moderate agitation (PANSS-EC score ≥14 and <20), patients will receive either sublingual dexmedetomidine 120mcg or oral lorazepam 2mg. For severe agitation (PANSS-EC ≥20), patients will receive either sublingual dexmedetomidine 180mcg or oral lorazepam 2mg. The PANSS-EC and ACES will be evaluated at baseline and after 15, 30, 60, and 120 minutes. ;

Related Conditions & MeSH terms

• Bipolar Disorder
• Dexmedetomidine
• Mood Disorders
• Psychomotor Agitation
• Psychotic Disorders
• Schizo Affective Disorder
• Schizophrenia

• NCT number: NCT06093451
• Study type: Interventional
• Source: Temple University
• Contact: Justin Faden, DO
• Phone: 2157070401
• Email: Justin.Faden@tuhs.temple.edu
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2023
• Completion date: July 1, 2024