Status:
UNKNOWN
PREvent First Episode Relapse (PREFER)
Lead Sponsor:
State University of New York - Downstate Medical Center
Collaborating Sponsors:
Janssen, LP
Conditions:
Schizophrenia
Eligibility:
All Genders
16-50 years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
Overview: Before the atypicals were introduced, some of the older antipsychotics were available in oral (pill or capsule) and long-acting (depot) versions. Despite the potential advantages of the depo...
Eligibility Criteria
Inclusion
- There is a 2 step inclusion/exclusion criteria, the first being for assessing overall eligibility to be enter, and then, for continued outpatient treatment for schizophrenia when clinically appropriate.
- Inclusion criteria for the first phase:
- Between 16-50 years of age
- Psychotic symptoms must have persisted at least one month prior to starting the current antipsychotic
- Continue to show some positive (psychotic) symptoms of schizophrenia
- A provisional clinical diagnosis of schizophreniform disorder,schizophrenia, or schizoaffective disorder
- Confirm that there was no previous history of significant pharmacological treatment with an antipsychotic medication
- Able to fully participate in the informed consent process
- Exclusion criteria for Study Phase I
- Unable to understand informed consent process
- A history of nonresponse to, or severe adverse events from, any prior exposure to oral risperidone
- Will not be living close enough to the medical center to return for follow-up visits or assessments
- Currently receiving medication over objection by court order
- Inclusion criteria for Study Phase II
- Key criteria for entry into Study Phase II are:
- Has clinically responded to the oral antipsychotic regimen
- Willingness to transition to receive evaluation and future pharmacologic treatment at the Schizophrenia Research Service
- Has retained capacity to understand the risks and benefits of the maintenance treatment with antipsychotics
- Willingness to sign informed consent to go into Study Phase II
- Exclusion criteria for Study Phase II
- Has not responded to the current oral antipsychotic regimen, or has had significant side effects to oral risperidone
- Explicit refusal to even consider the possibility of receiving maintenance antipsychotic by long-acting injection
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00220714
Start Date
November 1 2004
End Date
December 1 2007
Last Update
March 31 2008
Active Locations (2)
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1
Kings County Hospital Center
Brooklyn, New York, United States, 11203
2
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203