Status:

COMPLETED

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

Lead Sponsor:

Janssen Pharmaceutica N.V., Belgium

Conditions:

Schizophrenia

Psychotic Disorders

Eligibility:

All Genders

16+ years

Phase:

PHASE4

Brief 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 intr...

Detailed Description

Patients with acute schizophrenia are often anxious and uncertain because of the psychotic symptoms they are experiencing. These patients are in need of rapid help and symptom relief. Risperidone, a w...

Eligibility Criteria

Inclusion

  • Psychotic patients with schizophrenia who require rapid intervention
  • experiencing symptoms of a psychotic disorder
  • capable of choosing to be treated

Exclusion

  • Patients with a known hypersensitivity to the study drugs
  • have participated in an investigational drug trial within 30 days of study initiation
  • known to be unresponsive to treatment with risperidone or the comparator drug
  • known to have benzodiazepine dependence (addiction to this class of anti-anxiety drugs)

Key Trial Info

Start Date :

June 1 2001

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2003

Estimated Enrollment :

226 Patients enrolled

Trial Details

Trial ID

NCT00249171

Start Date

June 1 2001

End Date

February 1 2003

Last Update

January 14 2011

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