Zotepine Versus Risperidone in Aggressive Schizophrenic Patients of Acute Ward

Phase 4 Terminated 39 enrolled Astellas Pharma Inc Astellas Pharma Taiwan, Inc. · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the efficacy and tolerability of zotepine versus Risperidone in aggressive schizophrenic patients.

Timeline

Start: 2007-03
Primary completion: 2009-12
Completion: 2009-12

Outcome

Missed primary endpoint

Stopped (Enrollment): “Study was stopped due to difficulty in patient enrollment”

paper However, there were no significant differences in PANSS-EC total score (P = 0.265) and PANSS total score (P = 0.125) changes from baseline to study end point between the 2 treatment groups. PMID 24100785 ↗

Publications

Chan HY, Lin AS, Chen KP, Cheng JS, Chen YY, Tsai CJ. An open-label, randomized, controlled trial of zotepine and risperidone for acutely ill, hospitalized, schizophrenic patients with symptoms of agitation. J Clin Psychopharmacol. 2013 Dec;33(6):747-52. doi: 10.1097/JCP.0b013e31829e8168.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Risperidone	Other / unclassified	—	Oral
Subject	Zotepine	Small molecule	—	Oral