Clinical trial · Interventional
Subcutaneous Olanzapine for Hyperactive or Mixed Delirium
Study of Subcutaneous Olanzapine for Hyperactive or Mixed Delirium
NCT00512291CI-TRIAL-00005556completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Olanzapine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Olanzapine
- description
- 5 mg subcutaneous injection every 8 hours for 9 doses
- interventionNames
- Drug: Olanzapine
Primary outcomes (2)
- measure
- Participant Toxicity
- timeFrame
- Within 75 hours of the initial treatment
- description
- 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.
- measure
- Participant Hypotension
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.