Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00220714
Status:
UNKNOWN
Last Update Posted:
2008-03-31
First Post:
2005-09-13
Brief Title:
PREvent First Episode Relapse PREFER
Sponsor:
State University of New York - Downstate Medical Center
Organization:
State University of New York - Downstate Medical Center
Study Overview
Official Title:
Effectiveness of Long-Acting Risperidone in the Maintenance Treatment of First-Episode Schizophrenia
Status:
UNKNOWN
Status Verified Date:
2008-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Many patients who have recently received a diagnosis of schizophrenia eg 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
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
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 depot versions in those days clinicians in the United States have historically limited the use of long-acting depot antipsychotics to their most treatment-resistant chronic patients Therefore most clinicians did not routinely consider starting a long-acting antipsychotic early in the course of treatment such as after the first-episode of schizophrenia
This whole issue was less relevant after the atypical medications came out because they were only available in oral versions for long-term treatment Now that one of the atypical medications risperidone is available for use in the United States the issue of appropriate use of oral vs long-acting atypical is now very relevant to clinical practice
For first episode patients there are been two issues that suggest that the route of medication delivery is an important area to study First is that almost all first-episode patients will stop their medication too soon Second a there now is atypical antipsychotic available in a long-acting preparation long-acting risperidone but this option is not often used right away after a first episode so there is little guidance for clinicians about the effectiveness of long-acting antipsychotics used right away after a first-episode
Methods This study compares the effectiveness of the long-acting route of medication to improve adherence and reduce relapse among patients who have been recently diagnosed with schizophrenia or a related psychotic disorder After patients are stabilized with an atypical antipsychotic and have received patient and family psychoeducation consenting patients will be randomized to a prospective random-assignment open-label study comparing any available first-line oral atypical antipsychotic to long-acting risperidone for the maintenance treatment of patients recovering from acute treatment of first-episode schizophrenia
This study is divided into three study phases Study Phase I is the acute phase where consenting patients would be given an acute open-label trial of an oral antipsychotic Patients who respond within a maximum of 12 weeks to acute therapy will then be invited to participate in Phase II of the study Patients agreeing to Phase II will then be randomized into staying on their oral antipsychotic medication vs switching to a long-acting atypical antipsychotic long-acting risperidone Patients would be followed for 12 weeks to determine whether or not they accept a recommendation of long-acting antipsychotic or continued oral antipsychotic Then patients enter into Study Phase III where they are followed for at the remainder of the year We want to learn how often patients will accept their doctors recommendation of a long-acting injection whether persons taking their antipsychotic medication in long-acting form do better in terms of willingness to stay on their medication or have better symptom control or fewer side effects than persons where the doctor recommends the medication in oral pill form
Summary Patients recently diagnosed as suffering from schizophrenia eg the first-episode patient might benefit from an atypical antipsychotic given in a long-acting route of drug- delivery However long-acting antipsychotic therapy is not routinely considered in first-episode patients Studying the acceptance and ultimate effectiveness of a long-acting atypical antipsychotic would be very helpful in understanding how to help patients stay stable and ultimately prevent a revolving door pattern that if it continues can be devastating to the recovery process
This whole issue was less relevant after the atypical medications came out because they were only available in oral versions for long-term treatment Now that one of the atypical medications risperidone is available for use in the United States the issue of appropriate use of oral vs long-acting atypical is now very relevant to clinical practice
For first episode patients there are been two issues that suggest that the route of medication delivery is an important area to study First is that almost all first-episode patients will stop their medication too soon Second a there now is atypical antipsychotic available in a long-acting preparation long-acting risperidone but this option is not often used right away after a first episode so there is little guidance for clinicians about the effectiveness of long-acting antipsychotics used right away after a first-episode
Methods This study compares the effectiveness of the long-acting route of medication to improve adherence and reduce relapse among patients who have been recently diagnosed with schizophrenia or a related psychotic disorder After patients are stabilized with an atypical antipsychotic and have received patient and family psychoeducation consenting patients will be randomized to a prospective random-assignment open-label study comparing any available first-line oral atypical antipsychotic to long-acting risperidone for the maintenance treatment of patients recovering from acute treatment of first-episode schizophrenia
This study is divided into three study phases Study Phase I is the acute phase where consenting patients would be given an acute open-label trial of an oral antipsychotic Patients who respond within a maximum of 12 weeks to acute therapy will then be invited to participate in Phase II of the study Patients agreeing to Phase II will then be randomized into staying on their oral antipsychotic medication vs switching to a long-acting atypical antipsychotic long-acting risperidone Patients would be followed for 12 weeks to determine whether or not they accept a recommendation of long-acting antipsychotic or continued oral antipsychotic Then patients enter into Study Phase III where they are followed for at the remainder of the year We want to learn how often patients will accept their doctors recommendation of a long-acting injection whether persons taking their antipsychotic medication in long-acting form do better in terms of willingness to stay on their medication or have better symptom control or fewer side effects than persons where the doctor recommends the medication in oral pill form
Summary Patients recently diagnosed as suffering from schizophrenia eg the first-episode patient might benefit from an atypical antipsychotic given in a long-acting route of drug- delivery However long-acting antipsychotic therapy is not routinely considered in first-episode patients Studying the acceptance and ultimate effectiveness of a long-acting atypical antipsychotic would be very helpful in understanding how to help patients stay stable and ultimately prevent a revolving door pattern that if it continues can be devastating to the recovery process
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None