Clinical Trial: Inhaled Loxapine vs IM Haloperidol + Lorazepam for Agitation

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Randomized Double-blind Multicenter Double-dummy Non-inferiority Trial of Inhaled Loxapine and Intramuscular Haloperidol + Lorazepam for the Reduction of Agitation

Brief Summary: The primary objective of this study is to determine the noninferiority of inhaled loxapine compared to intramuscular haloperidol/lorazepam on agitation reduction at 120 minutes.

Detailed Summary: The primary objective of this study is to determine the noninferiority of inhaled loxapine compared to intramuscular haloperidol/lorazepam on agitation reduction at 120 minutes.
Sponsor: University of Arkansas

Current Primary Outcome: Reduction of agitation on PANSS-EC [ Time Frame: 120 minutes ]

agitation reduction


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Arkansas

Dates:
Date Received: March 16, 2017
Date Started: May 2017
Date Completion: April 15, 2019
Last Updated: April 18, 2017
Last Verified: April 2017