CompletedNot Applicable

Subcutaneous Olanzapine for Hyperactive or Mixed Delirium

United States25 participantsStarted 2005-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.

What they're measuring

Participant Toxicity

Timeframe: Within 75 hours of the initial treatment

Participant Hypotension

Timeframe: 3 Days

Trial details

NCT IDNCT00512291

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2007-08

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