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.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for phase_3 schizophrenia

Timeline

Completed

Started Mar 2008

Shorter than P25 for phase_3 schizophrenia

Geographic Reach

1 country

11 active sites

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

4 months study duration

Study Start

First participant enrolled

March 1, 2008

Completed

17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2008

Completed

3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2008

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

August 26, 2009

Completed

Last Updated

September 2, 2009

Status Verified

August 1, 2009

Enrollment Period

4 months

First QC Date

March 18, 2008

Results QC Date

July 16, 2009

Last Update Submit

August 26, 2009

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

Change From Baseline to 2 Hours Post the First Intramuscular (IM) Injection in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC)
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.
2 hours post first intramuscular (IM) injection

Secondary Outcomes (3)

Change From Baseline to Each Timepoint in Positive and Negative Syndrome Scale-Excited Component (PANSS-EC)
15 min, 30 min, 60 min, 90 min post first IM injection
Number of Responders at 2 Hours After First Intramuscular (IM) Injection
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
30 min, 60 min, 90 min and 2 hours post first IM injection

Study Arms (2)

IM olanzapine 10mg

EXPERIMENTAL

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).

Drug: Rapid Acting Intramuscular Olanzapine

IM placebo

PLACEBO COMPARATOR

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).

Drug: Isotonic sodium chloride solution

Interventions

Rapid Acting Intramuscular OlanzapineDRUG

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).

Also known as: LY170053, olanzapine, RAIM

IM olanzapine 10mg

Isotonic sodium chloride solutionDRUG

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).

IM placebo

Eligibility Criteria

Age20 Years - 64 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

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.

You may not qualify if:

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.
+1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (11)

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

Location

Gunma, 377-0055, Japan

Location

Kagoshima, 899-5652, Japan

Location

Kanagawa, 234-0051, Japan

Location

Kumamoto, 861-0002, Japan

Location

Okayama, 716-0061, Japan

Location

Okinawa, 904-0011, Japan

Location

Saga, 842-0192, Japan

Location

Tokyo, 187-8551, Japan

Location

Tottori, 682-0023, Japan

Location

Yamagata, 999-2221, Japan

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

OlanzapineSodium Chloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

March 18, 2008

First Posted

March 21, 2008

Study Start

March 1, 2008

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

September 2, 2009

Results First Posted

August 26, 2009

Record last verified: 2009-08

Locations

JP(11)

A Study Comparing Rapid Acting Intramuscular Olanzapine and Placebo in Agitated Patients With Schizophrenia

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

IM olanzapine 10mg

IM placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (11)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

IM olanzapine 10mg

IM placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (11)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations