A Study of Risperidone in Combination With Lorazepam Compared With Standard Therapy for Emergency Treatment of Schizophrenic Patients
Comparison of Oral Risperdal in Combination With Oral Lorazepam vs Standard Care Including Initial Conventional Neuroleptic IM Treatment, in Acute Schizophrenic Patients
1 other identifier
interventional
226
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 schizophrenia
Started Jun 2001
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 4, 2005
CompletedFirst Posted
Study publicly available on registry
November 7, 2005
CompletedJanuary 14, 2011
January 1, 2011
November 4, 2005
January 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment success, 2 hours after drug administration, indicated by patient being asleep or by improvement on Clinical Global Improvement (CGI) scale.
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Psychotic patients with schizophrenia who require rapid intervention
- experiencing symptoms of a psychotic disorder
- capable of choosing to be treated
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 15289699RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Pharmaceutica N.V. Clinical Trial
Janssen Pharmaceutica N.V.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 4, 2005
First Posted
November 7, 2005
Study Start
June 1, 2001
Study Completion
February 1, 2003
Last Updated
January 14, 2011
Record last verified: 2011-01