A Double-Blind Confirmatory Study Comparing Rapid-Acting Intramuscular Olanzapine and Rapid-Acting Intramuscular Placebo in Patients With an Exacerbation of Schizophrenia With Acute Psychotic Agitation

Eli Lilly and Company1 site in 1 country91 target enrollmentSeptember 2009

ConditionsSchizophrenia

InterventionsRapid-Acting Intramuscular Olanzapine Placebo

DrugsRapid-Acting Intramuscular Olanzapine Placebo

Overview

Phase: Phase 3
Intervention: Rapid-Acting Intramuscular Olanzapine
Conditions: Schizophrenia
Sponsor: Eli Lilly and Company
Enrollment: 91
Locations: 1
Primary Endpoint: Change From Baseline in the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) Total Score up to 2 Hours After the First Intramuscular (IM) Injection
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objectives of the study is to confirm if the efficacy of intramuscular injection (IM) olanzapine 10 milligrams (mg) in patients with an exacerbation of schizophrenia with acute psychotic agitation is greater than intramuscular placebo by comparing changes from baseline to 2 hours after the first IM injection of agitation.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

April 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients who meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision (DSM-IV-TR) criteria for schizophrenia.
•Patients with an exacerbation of schizophrenia with acute psychotic agitation.
•Patients who are hospitalized during the study.
•Patients, or proxy consenters, understand the nature of the study and sign on an informed consent document.
•The investigator or sub-investigator(s) judges that the patients are able to cooperate with all protocol procedures.
•Patients who are considered to be with agitation and appropriate candidates for treatment with intramuscular (IM) medication by the investigator or sub-investigator(s).
•The investigator or sub-investigator(s) believes that it is safe to administer IM olanzapine to the patients in consideration of safety, including the anticholinergic action of IM olanzapine.
•Patients who have a score of 1 or 2 on Agitation-Calmness Evaluation Scale (ACES) before the first IM injection of investigational product.

Exclusion Criteria

•Patients whose Global Assessment of Functioning (GAF) score is less than or equal to 40 within last 1 year before informed consent.
•Patients with defect.
•Patients whose agitation continues more than 2 weeks before informed consent.
•Patients who were previously treated with antipsychotics and were considered by the investigator or sub-investigator(s) to be treatment-resistant to antipsychotics.
•Patients who were treated by oral olanzapine at a dose of more than 20 milligrams (mg) for more than 4 weeks but did not improve.
•Patient who have a history of participation in clozapine trials or treatment with clozapine.
•Patients who have co-morbidity of mental retardation and personality disorder.
•Patients whose agitation is possibly due to brain lesions such as (but not limited to) head injury, stroke, brain breeding, and cerebral infection.
•Patients with sub-stupor or stupor.
•One or more seizures without a clear and resolved etiology. However, if the patient has had one or more seizures in the past with an identifiable etiology, and that etiology has been resolved, the patient may be entered.

Arms & Interventions

10 mg Olanzapine

Intervention: Rapid-Acting Intramuscular Olanzapine

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Change From Baseline in the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) Total Score up to 2 Hours After the First Intramuscular (IM) Injection

Time Frame: Baseline, up to 2 hours after first IM injection

Measures excitability and consists of the following 5 items from the PANSS: Excitement, Hostility, Tension, Uncooperativeness, and Poor Impulse Control. Each item is rated on a scale from 1 (absent) to 7 (extreme). The sum of the 5 items is defined as the PANSS-EC total score which ranges from 5 to 35.

Secondary Outcomes

Change From Baseline in PANSS-EC Total Score up to 90 Minutes After the First Intramuscular (IM) Injection(Baseline, 15 minutes, 30 minutes, 60 minutes, and 90 minutes after the first injection)
Change From Baseline in the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) Total Score up to 24 Hours After the First Intramuscular (IM) Injection(Baseline, up to 24 hours after first IM injection)
Percentage of Participants With 40% or Greater Percent Decrease in the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) Total Score up to 2 Hours After the First Intramuscular (IM) Injection(Up to 2 hours after the first (IM) injection)
Percentage of Participants With Scores of 4 to 7 in the Agitation-Calmness Evaluation Scale (ACES) Score up to 24 Hours After the First Intramuscular (IM) Injection(up to 24 hours after the first IM injection)
Percentage of Participants With Treatment-Emergent Extrapyramidal Symptoms Based on the Drug Induced Extrapyramidal Symptoms Scale (DIEPSS) Score up to 24 Hours After the First Intramuscular (IM) Injection(Up to 24 hours after the first IM injection)