A Study Comparing Rapid Acting Intramuscular Olanzapine and Placebo in Agitated Patients With Schizophrenia
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| ClinicalTrials.gov Identifier: NCT00640510 |
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Recruitment Status :
Completed
First Posted : March 21, 2008
Results First Posted : August 26, 2009
Last Update Posted : September 2, 2009
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Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Schizophrenia | Drug: Rapid Acting Intramuscular Olanzapine Drug: Isotonic sodium chloride solution | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 34 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Placebo-Controlled, Double-Blind Confirmatory Study of Rapid-Acting Intramuscular Olanzapine in Agitated Patients With Schizophrenia |
| Study Start Date : | March 2008 |
| Actual Primary Completion Date : | July 2008 |
| Actual Study Completion Date : | July 2008 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Schizophrenia
MedlinePlus related topics:
Schizophrenia
| Arm | Intervention/treatment |
|---|---|
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Experimental: IM olanzapine 10mg
Patients will receive at least one injection of Intramuscular (IM) olanzapine 10mg. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
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Drug: Rapid Acting Intramuscular Olanzapine
10mg/injection, IM. If patients do not respond to the first study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
Other Names:
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Placebo Comparator: IM placebo
Patients will receive at least one injection of Intramuscular placebo. If patients do not respond to the study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection).
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Drug: Isotonic sodium chloride solution
0.9% sodium chloride (NaCl) solution. If patients do not respond to the first study medication or if patients do not have enough improvement based on the investigator's judgment, and in addition, if the investigator judges it is reasonable, the patient will receive a second injection at the same dose strength as the first injection after 2 hours following the first injection (no later than 8 hours after the first injection). |
Primary Outcome Measures :
- Change From Baseline to 2 Hours Post the First Intramuscular (IM) Injection in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) [ Time Frame: 2 hours post first intramuscular (IM) injection ]
Secondary Outcome Measures :
- Change From Baseline to Each Timepoint in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) [ Time Frame: 15 min, 30 min, 60 min, 90 min post first IM injection ]
- Number of Responders at 2 Hours After First Intramuscular (IM) Injection [ Time Frame: 2 hours post first IM injection ]
- Number of Participants With Scores of 4 to 7 in the Agitation-Calmness Evaluation Scale (ACES) at Each Timepoint [ Time Frame: 30 min, 60 min, 90 min and 2 hours post first IM injection ]
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| Ages Eligible for Study: | 20 Years to 64 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00640510
Locations
| 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. | |
| Fukushima, Japan, 966-0902 | |
| 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, Japan, 377-0055 | |
| 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, Japan, 899-5652 | |
| 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, Japan, 234-0051 | |
| 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, Japan, 861-0002 | |
| 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, Japan, 716-0061 | |
| 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, Japan, 904-0011 | |
| 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, Japan, 842-0192 | |
| 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, Japan, 187-8551 | |
| 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, Japan, 682-0023 | |
| 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, Japan, 999-2221 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | 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) | Eli Lilly and Company |
Additional Information:
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00640510 History of Changes |
| Other Study ID Numbers: |
9622 F1D-JE-RA03 |
| First Posted: | March 21, 2008 Key Record Dates |
| Results First Posted: | August 26, 2009 |
| Last Update Posted: | September 2, 2009 |
| Last Verified: | August 2009 |
Additional relevant MeSH terms:
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Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Olanzapine Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents |