Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00488891
Status:
TERMINATED
Last Update Posted:
2012-08-29
First Post:
2007-06-18
Brief Title:
The Paliperidone ER Observational Study of Economic Functional and Clinical Outcomes in Patients With Schizophrenia
Sponsor:
Ortho-McNeil Janssen Scientific Affairs LLC
Organization:
Ortho-McNeil Janssen Scientific Affairs LLC
Study Overview
Official Title:
The Paliperidone ER Outcomes Study of Schizophrenia Patients in Typical Clinical Practice
Status:
TERMINATED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated because it was not enrolling at the expected rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POST
Brief Summary:
The purpose of this study is to examine the long-term economic functional and clinical outcomes in schizophrenia patients who require a change in antipsychotic treatment and are changed to either paliperidone extended release ER or another oral atypical antipsychotic agent AAP including aripiprazole olanzapine quetiapine risperidone or ziprasidone
Detailed Description:
This is a 12-month retrospective a study that looks backward in time usually using medical records and interviews with patients who are already known to have a diseaseprospective a study in which the patients are identified and then followed forward in time for the outcome of the study open-label all people involved know the identity of the assigned drug study of clinical functional and economic outcomes in schizophrenia patients who require a change in antipsychotic treatment The patients will be randomly study drug assigned by chance like flipping a coin assigned to receive either paliperidone extended release ER or one of two other prescriber-selected oral atypical antipsychotic AAPs The AAPs include aripiprazole olanzapine quetiapine risperidone or ziprasidone Baseline will be defined as the time when the patient begins to take paliperidone ER or the other AAP The study has a prepost design in which paliperidone ER patients serve as their own controls for the analyses of healthcare utilization If a potential patient needs to switch from their current antipsychotic medication they are eligible for this study The investigator will determine that the patient may benefit equally from switching to either paliperidone ER extended release or to either of 2 other antipsychotics Healthcare use over the 12-month period prior to baseline the pre-period will be compared to the 12-month period following the start of paliperidone ER or other AAP the post-period Data for both periods will be obtained by study investigators from enrolled patients medical charts Patients will continue to be followed in the study regardless of change in treatment until visit 5 at month 12 or if withdrawn from the study All patients will receive medical care consistent with local medical practices
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PAL-OUT-003 | OTHER | Ortho-McNeil Janssen Scientific Affairs LLC | None |