Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00249171
Status:
COMPLETED
Last Update Posted:
2011-01-14
First Post:
2005-11-04
Brief Title:
A Study of Risperidone in Combination With Lorazepam Compared With Standard Therapy for Emergency Treatment of Schizophrenic Patients
Sponsor:
Janssen Pharmaceutica NV Belgium
Organization:
Janssen Pharmaceutica NV Belgium
Study Overview
Official Title:
Comparison of Oral Risperdal in Combination With Oral Lorazepam vs Standard Care Including Initial Conventional Neuroleptic IM Treatment in Acute Schizophrenic Patients
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 intramuscular injection for emergency treatment of patients with schizophrenia
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 25 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 25 mg dose of lorazepam further dosing during the 24 hour period at investigators discretion Comparator drug of choice with or without lorazepam administered intramuscularly according to product labeling
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None