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Title:	An open-label, randomized, controlled trial of zotepine and risperidone for acutely ill, hospitalized, schizophrenic patients with symptoms of agitation
Authors:	Chan, H.-Y.;Lin, A.-S.;Chen, K.-P.;Cheng, J.-S.;Chen, Y.-Y.;Tsai, Chang-jer 蔡長哲
Contributors:	神經科研所
Keywords:	benzodiazepine;beta adrenergic receptor blocking agent;cholinergic receptor blocking agent;lorazepam;risperidone;zotepine;Abnormal Involuntary Movement Scale;adult;aggression;agitation;article;Barnes Akathisia Scale;body weight;clinical article;clinical assessment;Clinical Global Impression scale;comparative effectiveness;constipation;controlled study;critically ill patient;diarrhea;disease duration;drowsiness;drug dose increase;drug safety;DSM-IV;female;flu like syndrome;headache;hospital patient;human;hypothesis;insomnia;male;multicenter study;named inventories, questionnaires and rating scales;nervousness;open study;outcome assessment;Positive and Negative Syndrome Scale;priority journal;prolactin blood level;randomization;randomized controlled trial;schizophrenia;side effect;Simpson-Angus Scale;tachycardia;Udvalg for Kliniske Undersogelser Side Effect Rating Scale;uric acid blood level;Acute Disease;Adult;Antipsychotic Agents;Dibenzothiepins;Female;Hospitalization;Humans;Hyperprolactinemia;Hyperuricemia;Male;Middle Aged;Psychiatric Status Rating Scales;Psychomotor Agitation;Risperidone;Schizophrenia;Treatment Outcome
Date:	2013
Issue Date:	2015-04-17 15:20:56 (UTC+8)
Abstract:	Acutely ill, schizophrenic patients frequently require management of agitation. This study was conducted to compare the efficacy of oral zotepine and risperidone in hospitalized, acutely ill schizophrenic patients with symptoms of agitation.This was a 6-week, multicenter, randomized, open-label, parallel-group, flexible dosing study. Thirty-nine patients with schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) who met the criteria of a Positive and Negative Syndrome Scale (PANSS) total score of greater than or equal to 60 points, PANSS-excitement component (EC) score of greater than or equal to 14 points, and at least 1 PANSS-EC score of greater than or equal to 4 were randomly assigned to either the zotepine or risperidone group. The primary outcome was a comparison of the change in the PANSS-EC total score from baseline to the end of the study between groups.There was no significant between-group difference in dropout rates (zotepine, 15.8% [3/19]; risperidone, 20.0% [4/20]). The mean (SD) daily dose of zotepine from baseline to study end point ranged from 127.6 (62.3) to 236.8 (74.2) mg/d; the corresponding values for risperidone ranged from 3.3 (1.6) to 4.8 (1.7) mg/d. There were no statistically significant differences in patient characteristics, PANSS total score, and PANSS-EC total score between the zotepine and risperidone groups at baseline. Both groups showed significant reductions in the PANSS-EC total scores (zotepine,-10.1 [4.7], P < 0.001; risperidone,-8.0 [5.3], P < 0.001) and PANSS total scores (zotepine,-34.7 [15.8], P < 0.001; risperidone,-28.6 [14.3], P < 0.001). 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. Serum uric acid and prolactin decreased more in the zotepine group than the risperidone group (P < 0.001 and P = 0.018, respectively).Zotepine seemed to be as effective as risperidone in treating hospitalized, acutely ill, schizophrenic patients with agitation, and had the advantages of lowering hyperuricemia and hyperprolactinemia. Double-blind, fixed dose studies with a larger sample size of acutely ill, schizophrenic patients with agitation are needed to confirm the study results.© 2013 by Lippincott Williams & Wilkins.
Relation:	Journal of Clinical Psychopharmacology,Volume 33( 6), Pages 747-752
Data Type:	article
DOI link:	http://dx.doi.org/10.1097/JCP.0b013e31829e8168
DOI:	10.1097/JCP.0b013e31829e8168
Appears in Collections:	[Graduate Institute of Neuroscience] Periodical Articles

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