NCT00220714|UnknownPhase 4
PREvent First Episode Relapse (PREFER)
Effectiveness of Long-Acting Risperidone in the Maintenance Treatment of First-Episode Schizophrenia
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Effectiveness of Long-Acting Risperidone in the Maintenance Treatment of First-Episode Schizophrenia
Sponsor study identifier
interventional
80
1 country
2
Study Start
November 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
December 2007
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Many patients who have recently received a diagnosis of schizophrenia (e.g., "first-episode schizophrenia") respond very well to their antipsychotic medication when they are acutely ill. Once they are more stable, research has shown that first-episode patients need to remain on their antipsychotic medication. Follow-up studies show that stopping medication prematurely is the most common cause of relapse and readmission. It is important to have new ways to help patients stay stable in the community in order for them to continue on with their rehabilitation and recovery process. Over the last decade, new antipsychotic medications have been developed that are more effective and have fewer side effects than older antipsychotics. The new medicines are often called "atypical", and were only available by pill or capsule for long-term treatment. Most recently, one of the atypical medications - risperidone - became available as a long-acting injection that can be given once every 2 weeks. The hypothesis of this study is that patients recovering from an acute episode and who then go on to receive a long-acting version of atypical antipsychotic medication (long-acting risperidone microspheres) will stay on their medications for longer than those who take their atypical medication (any available first-line atypical) in the oral (pill) form.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2007
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2004
Date type not reportedThis date has not been verified as actual or estimated.
September 13, 2005
Actual (reported)September 22, 2005
Actual (reported)December 2007
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Likelihood of accepting a recommendation of long-acting atypical antipsychotic medication
Compare the time until the first episode of antipsychotic nonadherence as defined by 2 or more weeks of continuous and intentional cessation of all prescribed antipsychotic medication
Compare the total amount of outpatient days spent adherent to antipsychotic medication as a proportion of outpatient days in the study
Compare patient and family attitudes and satisfaction with antipsychotic medication given by long-acting route vs. oral route of drug delivery
5. Modify and adapt psychoeducational material designed for multiple episode patients to better fit the needs of recently diagnosed patients with schizophrenia.
Compare the likelihood of relapse and rehospitalization between long-acting atypical antipsychotic with all available first-line oral atypical agents
Compare the longitudinal course of symptoms and side effects of those remaining on long-acting atypicals to those remaining on oral antipsychotic regimens
Compare outcome differences between intent-to-treat assignments with actual observed treatment groups
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Kings County Hospital Center
Brooklyn, New York, 11203, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
Weiden PJ, Schooler NR, Weedon JC, Elmouchtari A, Sunakawa-McMillan A. Maintenance treatment with long-acting injectable risperidone in first-episode schizophrenia: a randomized effectiveness study. J Clin Psychiatry. 2012 Sep;73(9):1224-33. doi: 10.4088/JCP.11m06905. Epub 2012 Aug 7.
Weiden PJ, Schooler NR, Weedon JC, Elmouchtari A, Sunakawa A, Goldfinger SM. A randomized controlled trial of long-acting injectable risperidone vs continuation on oral atypical antipsychotics for first-episode schizophrenia patients: initial adherence outcome. J Clin Psychiatry. 2009 Oct;70(10):1397-406. doi: 10.4088/JCP.09m05284yel.
Peter J Weiden, M.D.
State University of New York - Downstate Medical Center
First Submitted
September 13, 2005
First Posted
September 22, 2005
Study Start
November 2004
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
December 2007
Estimated (date passed)Study of Three Doses of Aripiprazole in Patients With Acute Schizophrenia
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 31, 2008
Record last verified: 2008-03
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Source: ClinicalTrials.gov.
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