A Study of the Effectiveness and Safety of Risperidone Compared With Haloperidol and Placebo in Patients With Chronic Schizophrenia
Risperidone Versus Haloperidol Versus Placebo in the Treatment of Chronic Schizophrenia
1 other identifier
interventional
523
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 placebo and with a fixed 20 mg/day 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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
July 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; CGI severity; CGI overall change from baseline; safety evaluations conducted throughout the study.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with diagnosis of chronic schizophrenic disorder, according to the Diagnostic and Statistical Manual of Mental Diseases, 3rd edition (DSM-III-R) criteria and are inpatients at the beginning of study
- total score on the PANSS (Positive and Negative Syndrome Scale for Schizophrenia) rating scale at study entry of \>=60 and \<=120
- females of childbearing age must demonstrate adequate birth control measures and have a negative pregnancy test before study entry.
You may not qualify if:
- Patients with mental disorders other than chronic schizophrenic disorder
- patients with clinically significant organic or neurological diseases
- patients with epilepsy
- history of alcohol or drug abuse history within the 6 months before study entry.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen, LPlead
Related Publications (3)
Marder SR, Meibach RC. Risperidone in the treatment of schizophrenia. Am J Psychiatry. 1994 Jun;151(6):825-35. doi: 10.1176/ajp.151.6.825.
PMID: 7514366RESULTChouinard G, Jones B, Remington G, Bloom D, Addington D, MacEwan GW, Labelle A, Beauclair L, Arnott W. A Canadian multicenter placebo-controlled study of fixed doses of risperidone and haloperidol in the treatment of chronic schizophrenic patients. J Clin Psychopharmacol. 1993 Feb;13(1):25-40.
PMID: 7683702RESULTMarder SR, Davis JM, Chouinard G. The effects of risperidone on the five dimensions of schizophrenia derived by factor analysis: combined results of the North American trials. J Clin Psychiatry. 1997 Dec;58(12):538-46. doi: 10.4088/jcp.v58n1205.
PMID: 9448657RESULT
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
July 1, 1991
Last Updated
February 11, 2011
Record last verified: 2011-02