A Study of the Effectiveness and Safety of Risperidone Compared With Haloperidol in Patients With Chronic Schizophrenia
Risperidone in the Treatment of Chronic Schizophrenic Patients: an International Multicentre Double-blind Parallel-group Comparative Study Versus Haloperidol.
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interventional
1,579
0 countries
N/A
Brief Summary
The purpose of the study is to evaluate the effectiveness and safety of different doses of risperidone (an antipsychotic medication) compared with a fixed 10-mg dose of a standard antipsychotic, haloperidol, in patients with chronic schizophrenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 schizophrenia
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 Completion
Last participant's last visit for all outcomes
December 1, 1991
CompletedFirst Submitted
Initial submission to the registry
November 4, 2005
CompletedFirst Posted
Study publicly available on registry
November 7, 2005
CompletedFebruary 11, 2011
February 1, 2011
November 4, 2005
February 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent of patients showing clinical improvement, defined as a >=20% reduction in the total PANSS score from baseline to end of double-blind treatment, and the mean change from baseline to end of double-blind treatment in total PANSS score.
Secondary Outcomes (1)
Mean PANSS Positive Subscale Score; Mean PANSS Negative Subscale Score; mean PANSS General Psychopathology Subscale Score; mean separate PANSS item scores; safety evaluations conducted throughout the study.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of chronic schizophrenic disorder, according to the Diagnostic and Statistical Manual of Mental Diseases, 3rd edition (DSM-III-R) criteria
- total score on the PANSS at study entry of \>=60 and \<=120
- physical and neurological examination and ECG findings and clinical hematology, biochemistry, and urinalysis test results within normal limits before study entry
- patients must be able to be hospitalized the first 3 weeks of the study, if possible.
You may not qualify if:
- Patients with mental disorders other than chronic schizophrenic disorder
- patients with clinically significant organic or neurologic diseases
- women who are pregnant or breastfeeding, and women of childbearing potential without adequate birth control measures
- patients with epilepsy
- history of alcohol or drug abuse history within the previous 12 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen, LPlead
Related Publications (1)
Peuskens J. Risperidone in the treatment of patients with chronic schizophrenia: a multi-national, multi-centre, double-blind, parallel-group study versus haloperidol. Risperidone Study Group. Br J Psychiatry. 1995 Jun;166(6):712-26; discussion 727-33. doi: 10.1192/bjp.166.6.712.
PMID: 7545060RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen, LP Clinical Trial
Janssen, LP
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 4, 2005
First Posted
November 7, 2005
Study Completion
December 1, 1991
Last Updated
February 11, 2011
Record last verified: 2011-02