A Comparison of Risperidone With Haloperidol in Patients With Schizophrenia and Schizoaffective Disorder
A Comparison of Risperidone and Haloperidol for Prevention of Relapse in Subjects With Schizophrenia and Schizoaffective Disorders
2 other identifiers
interventional
396
0 countries
N/A
Brief Summary
The purpose of the study is to compare the time to relapse in patients with schizophrenia and schizoaffective disorders receiving risperidone or haloperidol (antipsychotic medications) for at least 1 year.
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 May 1996
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
May 1, 1996
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 10, 2005
CompletedFirst Posted
Study publicly available on registry
November 15, 2005
CompletedAugust 6, 2012
August 1, 2012
November 10, 2005
August 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to relapse (days)
Secondary Outcomes (1)
Change from baseline in total PANSS and PANSS subscale scores and CGI severity score; 1-year relapse rate; QOLI (quality of life); safety evaluations conducted throughout the study
Study Arms (2)
risperidone
ACTIVE COMPARATORhaloperidol
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of schizophrenia or schizoaffective disorder, according to the Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) criteria
- documented 1-year history of schizophrenia or schizoaffective disorder since the first drug treatment for psychotic symptoms
- history within the previous 24 months of being discharged from an inpatient psychiatric unit, had a partial hospitalization, completed crisis management intervention, or stayed in a hospital emergency room holding area for at least 12 hours
- must have received a stable dose of an antipsychotic medication for the 30 days before study entry
- in the investigator's judgment, must be able to discontinue any current antipsychotic medication.
You may not qualify if:
- Patients with clinically significant neurological disorders, with the exception of DSM-IV defined movement disorders that are caused by drugs
- patients with another current DSM-IV Axis I diagnosis (except nicotine or caffeine dependence)
- history or current diagnosis of gastrointestinal, liver, or kidney disease or other condition that might interfere with how the study drug is absorbed, processed, and excreted by the body
- pregnant or nursing women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen, LPlead
Related Links
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 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 10, 2005
First Posted
November 15, 2005
Study Start
May 1, 1996
Study Completion
September 1, 1998
Last Updated
August 6, 2012
Record last verified: 2012-08