A Study Comparing Rapid Acting Intramuscular Olanzapine and Placebo in Agitated Patients With Schizophrenia
2009년 8월 26일 업데이트: Eli Lilly and Company
A Placebo-Controlled, Double-Blind Confirmatory Study of Rapid-Acting Intramuscular Olanzapine in Agitated Patients With Schizophrenia
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.
연구 개요
상태
완전한
정황
연구 유형
중재적
등록 (실제)
34
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Fukushima, 일본, 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.
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Gunma, 일본, 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.
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Kagoshima, 일본, 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.
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Kanagawa, 일본, 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.
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Kumamoto, 일본, 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.
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Okayama, 일본, 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.
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Okinawa, 일본, 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.
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Saga, 일본, 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.
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Tokyo, 일본, 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.
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Tottori, 일본, 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.
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Yamagata, 일본, 999-2221
- 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.
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
20년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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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).
다른 이름들:
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위약 비교기: 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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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).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change From Baseline to 2 Hours Post the First Intramuscular (IM) Injection in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC)
기간: 2 hours post first intramuscular (IM) injection
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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.
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2 hours post first intramuscular (IM) injection
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline to Each Timepoint in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC)
기간: 15 min, 30 min, 60 min, 90 min post first IM injection
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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.
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15 min, 30 min, 60 min, 90 min post first IM injection
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Number of Responders at 2 Hours After First Intramuscular (IM) Injection
기간: 2 hours post first IM injection
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A responder was defined ast he patient with ≥ 40% decrease in the PANSS-EC total score at 2 hours after the first IM injection in comparison with baseline.
(See outcome measure 1 for description of PANSS-EC).
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2 hours post first IM injection
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Number of Participants With Scores of 4 to 7 in the Agitation-Calmness Evaluation Scale (ACES) at Each Timepoint
기간: 30 min, 60 min, 90 min and 2 hours post first IM injection
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The ACES differentiates agitation, calmness, and sleep-state, using a 9-point scale: 1 (Marked Agitation) to 9 (Unarousable).
Scores of 4 (Normal) to 7 (Marked Calmness) were used for this outcome measure.
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30 min, 60 min, 90 min and 2 hours post first IM injection
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2008년 3월 1일
기본 완료 (실제)
2008년 7월 1일
연구 완료 (실제)
2008년 7월 1일
연구 등록 날짜
최초 제출
2008년 3월 18일
QC 기준을 충족하는 최초 제출
2008년 3월 18일
처음 게시됨 (추정)
2008년 3월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2009년 9월 2일
QC 기준을 충족하는 마지막 업데이트 제출
2009년 8월 26일
마지막으로 확인됨
2009년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 9622
- F1D-JE-RA03
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