Study of Subcutaneous Olanzapine for Hyperactive or Mixed Delirium
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
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Within 75 hours of the initial treatment
Ahmed Elsayem, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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