Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00512291
Status:
COMPLETED
Last Update Posted:
2011-09-27
First Post:
2007-08-06
Brief Title:
Subcutaneous Olanzapine for Hyperactive or Mixed Delirium
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Study of Subcutaneous Olanzapine for Hyperactive or Mixed Delirium
Status:
COMPLETED
Status Verified Date:
2011-09
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:
None
Brief Summary:
The objective of this study is to determine the tolerability and safety of olanzapine administered as a subcutaneous injection to hospitalized patients with hyperactive or mixed delirium
Detailed Description:
Olanzapine is a drug designed to control agitationdelirium Olanzapine has been given by mouth and as an injection into the muscle which is painful and can increase a persons feelings of agitation In this study olanzapine will be given under the skin through a catheter Researchers hope that this will be less painful and agitating than when injected into the muscle
If you are found to be eligible to take part in this study you will have a catheter plastic tube placed under your skin This catheter will be used to give you the study medication Study drug will be given through the catheter every 8 hours for 9 doses Each shot should take about 1 to 2 minutes You will receive the drug at MDAnderson Cancer Center
Researchers will use the Richmond Agitation Scale to measure your agitation or sedation before each injection of olanzapine through the catheter It should take 5 to 10 minutes to answer the questions You will be evaluated for catheter site reaction at the time of injection at 30 minutes and 1 hour after the injection and before all further injections of study drug Your blood pressure will be evaluated before and 1 hour after the first two injections and then once a day while on study
If your agitation is not controlled you will receive haloperidol On the second day of treatment researchers will record the amount of haloperidol that you had to use in the previous 24 hours If the amount of haloperidol that you used is greater than a certain amount your dose of olanzapine will be increased Even if your dose of olanzapine is increased you may still be able to use haloperidol if needed
On the third day of treatment researchers will record the amount of haloperidol that you had to use in the previous 24 hours If the amount of haloperidol that you used is greater than a certain amount your dose of olanzapine will again be increased As before if your dose of olanzapine is increased you may still be able to use haloperidol if needed If you respond to olanzapine after 3 days of treatment you will be given the option to continue the drug off-study
If you develop severe side effects before you have completed the 9 doses treatment will be stopped If treatment on this study is stopped then you will consult with your doctor about receiving a different medication off study to help control your symptoms There is no long-term follow-up for this study
This is an investigational study Olanzapine has been FDA approved given into the muscle or by mouth for the treatment of agitation related to schizophrenia and bipolar mania a disorder involving mood swings from deep depression to feelings of elation A total of 25 patients will take part in this study All will be enrolled at MD Anderson
If you are found to be eligible to take part in this study you will have a catheter plastic tube placed under your skin This catheter will be used to give you the study medication Study drug will be given through the catheter every 8 hours for 9 doses Each shot should take about 1 to 2 minutes You will receive the drug at MDAnderson Cancer Center
Researchers will use the Richmond Agitation Scale to measure your agitation or sedation before each injection of olanzapine through the catheter It should take 5 to 10 minutes to answer the questions You will be evaluated for catheter site reaction at the time of injection at 30 minutes and 1 hour after the injection and before all further injections of study drug Your blood pressure will be evaluated before and 1 hour after the first two injections and then once a day while on study
If your agitation is not controlled you will receive haloperidol On the second day of treatment researchers will record the amount of haloperidol that you had to use in the previous 24 hours If the amount of haloperidol that you used is greater than a certain amount your dose of olanzapine will be increased Even if your dose of olanzapine is increased you may still be able to use haloperidol if needed
On the third day of treatment researchers will record the amount of haloperidol that you had to use in the previous 24 hours If the amount of haloperidol that you used is greater than a certain amount your dose of olanzapine will again be increased As before if your dose of olanzapine is increased you may still be able to use haloperidol if needed If you respond to olanzapine after 3 days of treatment you will be given the option to continue the drug off-study
If you develop severe side effects before you have completed the 9 doses treatment will be stopped If treatment on this study is stopped then you will consult with your doctor about receiving a different medication off study to help control your symptoms There is no long-term follow-up for this study
This is an investigational study Olanzapine has been FDA approved given into the muscle or by mouth for the treatment of agitation related to schizophrenia and bipolar mania a disorder involving mood swings from deep depression to feelings of elation A total of 25 patients will take part in this study All will be enrolled at MD Anderson
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