A Study of Risperidone in Combination With Lorazepam Compared With Standard Therapy for Emergency Treatment of Schizophrenic Patients
Information source: Janssen Pharmaceutica N.V., Belgium
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psychotic Disorders; Emergency Treatment; Schizophrenia
Intervention: risperidone (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Janssen Pharmaceutica N.V., Belgium Official(s) and/or principal investigator(s):
Janssen Pharmaceutica N.V. Clinical Trial, Study Director, Affiliation: Janssen Pharmaceutica N.V., Belgium
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.
Clinical Details
Official title: Comparison of Oral Risperdal in Combination With Oral Lorazepam vs Standard Care Including Initial Conventional Neuroleptic IM Treatment, in Acute Schizophrenic Patients
Study design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Treatment success, 2 hours after drug administration, indicated by patient being asleep or by improvement on Clinical Global Improvement (CGI) scale.
Secondary outcome: Hostility and agitation (as assessed by BPRS), degree of sedation, and ability to interact with physician at 0, 1, 2, and 24 hours; Clinical Global Impression (CGI) - Improvement subscale at 1 and 24 hours; adverse events throughout the study.
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 widely used antipsychotic medication, is effective against positive and
negative symptoms of schizophrenia, has a rapid onset of action, a low incidence of
extrapyramidal symptoms, and, in general, mild adverse events. This is an open-label trial of
2 mg dose of an oral formulation of risperidone in combination with 2 to 2. 5 mg of oral
lorazepam compared with standard care, which consists of a conventional neuroleptic drug
administered via an intramuscular injection, with or without lorazepam. Patients requiring
emergency care are offered a choice of these two therapies and are monitored for 24 hours
after initial treatment. Optional follow up may be performed after 2, 3, and 7 days. The
primary measure of effectiveness is the success of the treatment 2 hours after the drug is
administered, as indicated by the patient being asleep or by showing improvement on the
Clinical Global Impression (CGI) Improvement subscale. Additional effectiveness assessments
include an evaluation of hostility and agitation, as assessed by Brief Psychiatric Rating
Scale (BPRS), the degree of sedation, and the ability of the patient to interact with the
physician at 1, 2, and 24 hours after the start of treatment. Safety assessments include the
incidence of adverse events throughout the treatment and follow up periods. The study
hypothesis is that oral risperidone combined with lorazepam is more effective than therapy
with conventional neuroleptic intramuscular agents, with or without lorazepam, for emergency
treatment of patients with schizophrenia.
Single, oral 2 mg dose of risperidone and a single, oral 2 to 2. 5 mg dose of lorazepam;
further dosing during the 24 hour period at investigator's discretion. Comparator drug of
choice (with or without lorazepam) administered intramuscularly according to product
labeling.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Psychotic patients with schizophrenia who require rapid intervention
- Experiencing symptoms of a psychotic disorder
- Capable of choosing to be treated
Exclusion Criteria:
- 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)
Locations and Contacts
Additional Information
Starting date: May 2001
Ending date: February 2003
Last updated: April 6, 2007
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