NCT00512291

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2007

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

September 27, 2011

Status Verified

September 1, 2011

Enrollment Period

2.2 years

First QC Date

August 6, 2007

Last Update Submit

September 26, 2011

Conditions

Advanced Cancer

Keywords

Advanced CancerHyperactive DeliriumMixed DeliriumOlanzapine

Outcome Measures

Primary Outcomes (2)

  • Participant Toxicity

    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

  • Participant Hypotension

    Participants who experience a drop in blood pressure below 90/50 mm Hg within 60 minutes post study drug administration. Blood pressure evaluated immediately before and 1 hour after each of the first 2 injections, and then daily thereafter.

    3 Days

Secondary Outcomes (1)

  • Participant Richmond Agitation Sedation Scale (RASS)

    3 Days

Study Arms (1)

Olanzapine

EXPERIMENTAL

5 mg subcutaneous injection every 8 hours for 9 doses

Drug: Olanzapine

Interventions

OlanzapineDRUG

5 mg subcutaneous injection every 8 hours for 9 doses. Each injection should take about 1 to 2 minutes.

Also known as: Fluoxetine, Symbyax
Olanzapine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Interventions

OlanzapineFluoxetineolanzapine-fluoxetine combination

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPropylaminesAminesOrganic Chemicals

Study Officials

  • Ahmed Elsayem, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2007

First Posted

August 7, 2007

Study Start

June 1, 2005

Primary Completion

August 1, 2007

Study Completion

August 1, 2009

Last Updated

September 27, 2011

Record last verified: 2011-09

Locations

US(1)