Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00330863
Status:
COMPLETED
Last Update Posted:
2018-07-10
First Post:
2006-05-26
Brief Title:
Preventing Relapse in Schizophrenia Oral Antipsychotics Compared To Injectables Evaluating Efficacy
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
Preventing Relapse Oral Antipsychotics Compared To Injectables Evaluating Efficacy PROACTIVE
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
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:
PROACTIVE
Brief Summary:
This study is designed to find out whether taking antipsychotic medication once every two weeks by injection compared to taking daily oral medication will help people with schizophrenia maintain better control of their symptoms
Detailed Description:
As is the case with many chronic illnesses it can be challenging for people with schizophrenia to take multiple pills every day on a long-term basis At the same time missing or discontinuing the anti-psychotic medications that treat schizophrenia substantially increases the risk of relapse and re-hospitalization This study will determine how effective long-acting injectable risperidone is compared to oral antipsychotic medications to help patients who have schizophrenia Patients who enroll in the study will be randomly assigned to receive either long-acting injectable risperidone or to receive oral atypical antipsychotic medication The atypical antipsychotics that are included for patients in the oral group are aripiprazole olanzapine quetiapine risperidone and ziprasidone Patients in the oral group will receive whichever of the five atypical antipsychotic medications they and their study doctor decide is best for them Patients in the oral group will be allowed to switch to others of the five medications during the study if they and their doctor think that is best
Patients in this study will be evaluated at the beginning of the study and then again every two weeks for up to 30 months 2 12 years Each two-week visit will take about 20 minutes At the visit patients will receive medication and will be examined for side effects of the medications their vital signs heart rate blood pressure weight and waist measurement will be measured and they will be asked a few questions about attendance at visits and taking medication The visit that occurs every three months will take about one hour instead of 20 minutes and will include additional questions an examination for muscle stiffness or abnormal body movements and an interview from a member of the research team conducted using computer technology In addition blood and urine samples may be collected about seven times throughout the 30 months of the study treatment Patients who enroll in this study after the halfway point of the study may not receive a full 30 months of treatment but it is planned that all patients will have the opportunity to receive no less than 18 months of treatment
Patients in this study will be evaluated at the beginning of the study and then again every two weeks for up to 30 months 2 12 years Each two-week visit will take about 20 minutes At the visit patients will receive medication and will be examined for side effects of the medications their vital signs heart rate blood pressure weight and waist measurement will be measured and they will be asked a few questions about attendance at visits and taking medication The visit that occurs every three months will take about one hour instead of 20 minutes and will include additional questions an examination for muscle stiffness or abnormal body movements and an interview from a member of the research team conducted using computer technology In addition blood and urine samples may be collected about seven times throughout the 30 months of the study treatment Patients who enroll in this study after the halfway point of the study may not receive a full 30 months of treatment but it is planned that all patients will have the opportunity to receive no less than 18 months of treatment
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 |
|---|---|---|---|
| DSIR 83-ATAP | OTHER_GRANT | National Institute of Mental Health | httpsreporternihgovquickSearchU01MH070012 |
| U01MH070010 | NIH | None | None |
| U01MH070007-01 | NIH | None | None |
| U01MH070023 | NIH | None | None |
| U01MH070011 | NIH | None | None |
| U01MH070009 | NIH | None | None |
| U01MH070008 | NIH | None | None |
| U01MH070017 | NIH | None | None |
| U01MH070016 | NIH | None | None |
| U01MH070012 | NIH | None | None |