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Oral risperidone plus oral lorazepam versus standard care with intramuscular conventional neuroleptics in the initial phase of treating individuals with acute psychosis

Lejeune, Josepha; Larmo, Ilkkab; Chrzanowski, Wlodzimierzc; Witte, Roeld; Karavatos, Athanasiose; Schreiner, Andreasf; Lex, Aliceg; Medori, Rossellag

International Clinical Psychopharmacology: September 2004 - Volume 19 - Issue 5 - p 259-269
doi: 10.1097/01.yic.0000138820.78121.0e
Original Articles

Although atypical antipsychotics are now considered first line treatments for schizophrenia, intramuscular (i.m.) conventional neuroleptics are often still considered necessary in emergency treatment of acute psychoses. This European, multicentre, open-label, active-controlled trial compared oral risperidone plus oral lorazepam to standard care with i.m. conventional neuroleptics with or without lorazepam in the emergency treatment of acutely psychotic patients. Patients were allowed to choose either oral risperidone (a single dose of 2 mg and 2.0–2.5 mg lorazepam; 121 patients) or standard i.m. treatment (conventional neuroleptic with or without lorazepam; 105 patients). No additional treatment was allowed for 2 h. Primary outcome was the percentage of patients with treatment success (asleep or at least much improved on Clinical Global Impression-global improvement scale) 2 h after treatment initiation. Baseline characteristics were similar in both treatment groups. Oral risperidone plus oral lorazepam was more successful at 2 h (66.9%) and significantly non-inferior compared to standard i.m. care (54.3%; P=0.0003), and the incidence of extrapyramidal symptoms (EPS) was lower (1.7%) compared to standard i.m. care (9.5%). In acutely psychotic patients requiring emergency treatment, oral risperidone/oral lorazepam was at least as effective as i.m. conventional neuroleptic treatment with or without lorazepam. Oral risperidone plus lorazepam rapidly reduces symptoms, including aggression, and causes fewer EPS.

aCHR Citadelle, Liège, Belgium

bCentral Mental Health Unit, Auroran Hospital, Helsinki, Finland

cPsychiatric Clinic of Medical Academy Bialystok, Choroszcs, Poland

dMeander MC, Amersfoort, Netherlands

e University Psychiatric Clinic, University of Thessaloniki, Papageorgiou General Hospital, Thessaloniki, Greece

fMedical and Scientific Affairs, Janssen-Cilag, Neuss, Germany

gMedical Affairs EMEA, Janssen-Cilag EMEA, Neuss, Germany

Correspondence and requests for reprints to Rossella Medori, Janssen-Cilag–EMEA, Raiffeisenstrasse 8, D-41470 Neuss, Germany

Tel: +49 89 17 11 99 35; e-mail:

Received 28 January 2003 Accepted 24 June 2004

© 2004 Lippincott Williams & Wilkins, Inc.