CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 72 enrolled
Drug / intervention
Quetiapine +3 moredrug
Likely dose
Quetiapine 300mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00457366
NCT00457366Phase 4Completed

A Comparison Study of the Efficacy of a Rapid Titration of Quetiapine and Haloperidol in Agitated Adults in an Emergency Setting.

University of Southern California·interventional·Posted Apr 6, 2007·Updated Jul 26, 2019

In Brief

A Phase 4 clinical trial evaluating Quetiapine, Haloperidol, and 2 other interventions for Agitation. Completed, enrolled 72 participants across 1 site.

Detailed Summary

In the Psychiatric Emergency Room, agitated patients are treated routinely with an I.M. Haloperidol "cocktail" (Haloperidol 5 mg, Lorazepam 2 mg, Cogentin 2 mg), which has proved to be an effective treatment. However, since it is an intramuscular injection, it is more complicated and perhaps less acceptable to patients as well as more likely to cause EPS (extrapyramidal symptoms). Of late in our emergency room, we started using high dose Quetiapine 300 mg PO to replace the "cocktail" for treating agitation. It has shown promising results.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAgitation
CountriesUnited States
CollaboratorsAstraZeneca

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 6, 2007
Enrollment StartMay 1, 2006
Primary CompletionAug 1, 2008
Study CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 19.2 years ago

Interventions

Quetiapinedrug

Quetiapine 300mg PO/Initial dose and repeat dose at 2 hours if deemed clinically necessary up to a maximum dose of Quetiapine 600mg PO QD

Haloperidoldrug

given in combination with Lorazepam 2 mg IM, Cogentin 2 mg IM; repeated at 2 hours as deemed clinically necessary

Lorazepamdrug

given in combination with Haloperidol 5mg IM and cogentin 2mg IM; repeated at 2 hours as deemed clinically necessary.

Cogentindrug

given in combination with haloperidol 5mg IM, and Lorazepam 2mg IM; repeated at 2 hours as deemed clinically necessary.