A Study of Risperidone in Combination With Lorazepam Compared With Standard Therapy for Emergency Treatment of Schizophrenic Patients

Phase 4 Completed 226 enrolled Janssen Pharmaceutica N.V., Belgium

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to show that risperidone (an antipsychotic medication) combined with lorazepam (an anti-anxiety medication) is more effective than conventional therapy administered by intramuscular injection for emergency treatment of patients with schizophrenia.

Timeline

Start: 2001-06
Primary completion: —
Completion: 2003-02

Outcome

Met primary endpoint

paper 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) PMID 15289699 ↗

Publications

Results Lejeune J, Larmo I, Chrzanowski W, Witte R, Karavatos A, Schreiner A, Lex A, Medori R. Oral risperidone plus oral lorazepam versus standard care with intramuscular conventional neuroleptics in the initial phase of treating individuals with acute psychosis. Int Clin Psychopharmacol. 2004 Sep;19(5):259-69. doi: 10.1097/01.yic.0000138820.78121.0e.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Risperidone	Other / unclassified	2 mg	Oral