Subcutaneous Olanzapine for Hyperactive or Mixed Delirium

Completed · Not applicable

Conditions studied: Advanced Cancer

In brief

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.

Key facts

Study ID

NCT00512291

Run by

M.D. Anderson Cancer Center

People needed

25

Starts

2005-06-01

Expected to finish

2009-08-01

Last updated by the study team

2011-09-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Hospitalized patients on the Acute Palliative Care Unit (G12NW) at the University of Texas MD Anderson Cancer Center
• Age > 18 years of age (Olanzapine IM has not been evaluated in pediatric patients.)
• Patients must have an acceptable surrogate capable of giving consent on the subject's behalf.
• Richmond Agitation-Sedation Score (RASS) of >/= 1
• Mini Mental Status Exam score of less than 24
• Hyperactive or mixed delirium not responsive to at least 10 mg of haloperidol within the last 24 hours

You may not qualify if…

• Known hypersensitivity to any ingredient of olanzapine IM
• The following reactions to haloperidol: A) Acute dystonia B) Hypersensitivity or previous intolerance to haloperidol C) Extra pyramidal side effects
• History of narrow-angle glaucoma.
• Systolic blood pressure < 90 mm Hg
• If they received an injectable depot neuroleptic within less than one dosing interval of study initiation
• Within 7 days of starting study drug, documentation of: a. Fasting blood glucose (or finger stick glucose check) > 250 mg/dl b. Absolute neutrophil count of < 500 or platelets < 50,000
• The use of any benzodiazepines or neuroleptic medications, besides haloperidol, while the patient is enrolled on study, is prohibited.

Where it is running

• U.T.M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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