A Pilot, Open-Label Safety Study of Quetiapine for Treatment of Moderate Psychotic Agitation in the Emergency Setting

Abstract

The goal of this pilot study was primarily to explore the safety and, secondarily, the efficacy of the use of "prn" quetiapine for treatment of moderate agitation accompanied by psychosis in an emergency department setting. This was an open-label study in which 20 patients with psychotic agitation were treated in the emergency department with 100, 150, or 200 mg of quetiapine. Physicians who were unaffiliated with the study established the diagnoses and selected the doses to be used for each patient. A rater who was blinded to the dose performed the assessments. The primary safety measure was the onset of orthostatic hypotension. The primary efficacy measure was a 40% reduction in scores on the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) over 120 minutes. The secondary efficacy measure was a reduction of 2 points or more on the Behavioral Activity Rating Scale (BARS) at 120 minutes post-dose. All subjects provided written informed consent. With regard to safety outcomes, 40% of subjects exhibited orthostasis by 120 minutes, although only 25% of these patients described clinically significant symptoms. In terms of efficacy, 50% of subjects experienced at least a 40% reduction in PANSS-EC scores at 2 hours, while 68.8% showed reductions of 2 points or more in scores on the BARS over the same time period. Quetiapine demonstrated some efficacy as a sedative agent in the emergency setting, although no clear dose-response pattern emerged over the narrow dose range tested. Orthostasis was common and did not correlate with dosing. This small study did not support the use of quetiapine to treat acute agitation in potentially volume-depleted patients.