A Study Comparing Rapid Acting Intramuscular Olanzapine and Placebo in Agitated Patients With Schizophrenia
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Rapid Acting Intramuscular Olanzapine (Drug); Isotonic sodium chloride solution (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s): Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company
Summary
The primary objectives of the study is to confirm if the efficacy of IM olanzapine in
patients with schizophrenia is greater than IM placebo by comparing changes from baseline to
2 hours post first IM injection of agitation.
Clinical Details
Official title: A Placebo-Controlled, Double-Blind Confirmatory Study of Rapid-Acting Intramuscular Olanzapine in Agitated Patients With Schizophrenia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change From Baseline to 2 Hours Post the First Intramuscular (IM) Injection in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC)
Secondary outcome: Change From Baseline to Each Timepoint in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC)Number of Responders at 2 Hours After First Intramuscular (IM) Injection Number of Participants With Scores of 4 to 7 in the Agitation-Calmness Evaluation Scale (ACES) at Each Timepoint
Eligibility
Minimum age: 20 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients have met Diagnostic and Statistical Manual of Mental Disorders Fourth
Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia.
- Male or female, at least 20 years and less than 65 years old.
- Inpatients during the study.
- Each patient, or a proxy consenter, understand the nature of the study and must sign
an informed consent document. The patient is able to cooperate with all study
procedures in the view of the investigator.
- Patients are considered, by the investigator or subinvestigator, to be clinically
agitated and appropriate candidates for treatment with intramuscular (IM) medication.
The investigator must believe that it is safe to administer IM olanzapine to the
patients with respect to the safety profile, including the anticholinergic properties
of Olanzapine IM.
- Patients have a minimum total score of ≧ 20 on the five items of the Positive and
Negative Syndrome Scale-Excited Component (PANSS-EC) using the 1-7 scoring system
prior to the first injection of study drug.
- Patients have a score of 1 or 2 on the Agitation-Calmness Evaluation Scale (ACES)
prior to the first injection of study drug.
Exclusion Criteria:
- Patients who were previously treated with oral olanzapine and are considered to be
treatment-resistant to oral olanzapine, in the opinion of the investigator.
- Patients who have a history of allergic reaction or intolerance to study medication.
- Patients who show evidence of clinically significant bradycardia or arrhythmia
obtained either from a physical exam or an electrocardiogram (ECG).
- Patients who require concomitant treatment with any other medication with primary
central nervous system activity, other than those allowed as specified in section
"concomitant treatment".
- Patients who have acute, serious or unstable medical conditions, including (but not
limited to) hepatic insufficiency (specifically any degree of jaundice), recent
cerebrovascular accidents, uncontrolled seizure disorders, serious acute systemic
infection or immunologic disease, unstable cardiovascular disorders (including
ischemic heart disease), renal, gastroenterologic, respiratory, endocrinologic,
neurologic, or hematologic diseases.
- Patients with inadequately controlled diabetes, or patients whose treatment for
diabetes were changed within 4 weeks prior to the first injection of the study drug.
The investigator's discretion will supersede even if the patients do not meet the
above criteria for concurrent diabetes.
- Patients who have a known neutrophil count or total of segmented cell and band cell
counts of <1,500 /millimeter cubed (mm3).
- Patients who have a known alanine aminotransferase/serum glutamic pyruvic
transaminase (ALT/SGPT) values ≧2 times the normal upper limit of the performing
laboratory (ULN) or aspartate aminotransferase/serum glutamic oxaloacetic
transaminase (AST/SGOT) values ≧3 times the ULN or total bilirubin values ≧1. 5 times
the ULN.
- Patients who have a known serum triglycerides ≧500 milligrams/deciliter (mg/dL).
- Electrocardiogram abnormalities considered clinically significant by the
investigator.
- Patients who have had treatment with injectable depot antipsychotics within one
injection interval prior to study drug administration.
- Patients who have received treatment with antipsychotics or other prohibited
concomitant medicines showing in the section "prohibited concomitant medicines"
within 2 hours prior to the first IM study drug administration.
- Patients who have had treatment with benzodiazepines within 4 hours prior to first IM
study drug administration.
- Patients who have been administered epinephrine within 24 hours prior to the first IM
study drug administration.
- Patients who have received treatment with psychostimulants or reserpine within 7 days
prior to the first IM study drug administration.
- Patients who have received beta blockers or calcium channel blockers previously, must
have been taking the same medication at the same dose for 28 days prior to the first
IM study drug administration. No beta blockers or calcium channel blockers may be
administered within 24 hours of the first IM study drug injection, or any time during
the double blind phase.
Locations and Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Fukushima 966-0902, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Gunma 377-0055, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Kagoshima 899-5652, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Kanagawa 234-0051, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Kumamoto 861-0002, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Okayama 716-0061, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Okinawa 904-0011, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Saga 842-0192, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Tokyo 187-8551, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Tottori 682-0023, Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Yamagata 999-2221, Japan
Additional Information
Lilly Clinical Trial Registry
Starting date: March 2008
Last updated: August 26, 2009
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