Subcutaneous Olanzapine for Hyperactive or Mixed Delirium
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study of Subcutaneous Olanzapine for Hyperactive or Mixed Delirium|
- Participant Toxicity [ Time Frame: Within 75 hours of the initial treatment ] [ Designated as safety issue: Yes ]Toxicity defined as urticaria, injection site reactions, and/or hypotension. At time 0, 0.5, and 1 hour after the first injection of study drug and prior to all subsequent injections of study drug, urticaria and injection site reaction assessed using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 3.0. Blood pressure evaluated immediately before and 1 hour after each of the first 2 injections, and then daily thereafter.
- Participant Hypotension [ Time Frame: 3 Days ] [ Designated as safety issue: Yes ]Participants who experience a drop in blood pressure below 90/50 mm Hg within 60 minutes post study drug administration. Blood pressure evaluated immediately before and 1 hour after each of the first 2 injections, and then daily thereafter.
- Participant Richmond Agitation Sedation Scale (RASS) [ Time Frame: 3 Days ] [ Designated as safety issue: No ]Evaluation of RASS at time 0, once the injection is completed, at 0.5 hours post-injection, and at 1 hour post-injection for the first injection of study drug, and then prior to each injection of study drug to determine efficacy. Treatment efficacy defined as: RASS Score of less than 1 prior to the last dose on the third day; and Total haloperidol usage of less than 8 mg per day. Haloperidol amounts recorded for previous 24 hours.
|Study Start Date:||June 2005|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
5 mg subcutaneous injection every 8 hours for 9 doses
5 mg subcutaneous injection every 8 hours for 9 doses. Each injection should take about 1 to 2 minutes.
Olanzapine is a drug designed to control agitation/delirium. Olanzapine has been given by mouth and as an injection into the muscle, which is painful and can increase a person's 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 M.D.Anderson 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 M.D. Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00512291
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ahmed Elsayem, MD||M.D. Anderson Cancer Center|