Overview

Subcutaneous Olanzapine for Hyperactive or Mixed Delirium

Status:
Completed

Trial end date:
2009-08-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Treatments:

Fluoxetine
Olanzapine

Criteria

Inclusion Criteria:

1. Hospitalized patients on the Acute Palliative Care Unit (G12NW) at the University of
Texas MD Anderson Cancer Center

2. Age > 18 years of age (Olanzapine IM has not been evaluated in pediatric patients.)

3. Patients must have an acceptable surrogate capable of giving consent on the subject's
behalf.

4. Richmond Agitation-Sedation Score (RASS) of >/= 1

5. Mini Mental Status Exam score of less than 24

6. Hyperactive or mixed delirium not responsive to at least 10 mg of haloperidol within
the last 24 hours

Exclusion Criteria:

1. Known hypersensitivity to any ingredient of olanzapine IM

2. The following reactions to haloperidol: A) Acute dystonia B) Hypersensitivity or
previous intolerance to haloperidol C) Extra pyramidal side effects

3. History of narrow-angle glaucoma.

4. Systolic blood pressure < 90 mm Hg

5. If they received an injectable depot neuroleptic within less than one dosing interval
of study initiation

6. 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

7. The use of any benzodiazepines or neuroleptic medications, besides haloperidol, while
the patient is enrolled on study, is prohibited.