A Study of Olanzapine in Patients With Schizophrenia | NCT00970281

NCT00970281

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
F1D-JE-RACD	Other Identifier	Eli Lilly and Company

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
10 mg Olanzapine	Experimental		Drug: Rapid-Acting Intramuscular Olanzapine
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rapid-Acting Intramuscular Olanzapine	Drug	Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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.	Baseline, up to 2 hours after first IM injection

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in PANSS-EC Total Score up to 90 Minutes After the First Intramuscular (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.

Eligibility Module

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.
Patients who have a history of DSM-IV-TR substance (except caffeine and nicotine) abuse within the past 30 days or substance dependence within the past 6 months before informed consent. Or patients who have a history of using illegal drug.
Patients whose agitation is caused by substance abuse or neurologic conditions, in the opinion of the investigator or sub-investigator(s).
Patients who have a diagnosis of Parkinson's disease or dementia.
Patients who are actively suicidal (at high risk for suicide attempt) in the opinion of the investigator or sub-investigator(s).
Patients with inadequately controlled diabetes, or patients whose treatment for diabetes has been changed within 4 weeks before the first IM injection of the investigational product. The investigator's discretion will supersede even if the patients do not meet the above criteria for concurrent diabetes.
Patients who have received haloperidol decanoate fluphenazine decanoate, or fluphenazine enanthate within 8 weeks before the first IM injection of investigational product.
Patients who have received risperidone long-acting injection within 12 weeks before the first IM injection of investigational product.
Patients who have a history of receiving injectable depot antipsychotics other than haloperidol decanoate, fluphenazine decanoate, fluphenazine enanthate and risperidone long-acting injection.
Patients who have received antipsychotics or other prohibited concomitant medicines within 2 hours before the first IM injection of investigational product.
Patients who have received benzodiazepines within 4 hours before the first IM injection of investigational product.

Contacts/Locations Module

Name	Affiliation	Role
Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time(UTC/GMT-5hours, EST)	Eli Lilly and Company	Study Director

Locations

Facility	Status	City	State	ZIP	Country	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.		Aichi		470-1168

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23311957	Derived	Katagiri H, Fujikoshi S, Suzuki T, Fujita K, Sugiyama N, Takahashi M, Gomez JC. A randomized, double-blind, placebo-controlled study of rapid-acting intramuscular olanzapine in Japanese patients for schizophrenia with acute agitation. BMC Psychiatry. 2013 Jan 11;13:20. doi: 10.1186/1471-244X-13-20.

IPD Sharing Statement Module

No data available

No data is available for this block.

Arm/Group Information

ID	Title	Description
FG000	10 mg Olanzapine	Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
FG001	Placebo	Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00046 subjects FG00145 subjects
Full Analysis Set		FG00045 subjects1 participant in the olanzapine arm discontinued before the first intramuscular (IM) injection. FG00145 subjects
COMPLETED		FG00044 subjects FG00129 subjects
NOT COMPLETED		FG0002 subjects FG00116 subjects

Type	Comment	Reasons
Lack of Efficacy		FG0001 subjects FG00114 subjects
Withdrawal by Subject		FG0000 subjects FG001

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	10 mg Olanzapine	Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
BG001	Placebo

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

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.

Participants with a baseline and a value at the time, last observation carried forward (LOCF).

Posted

Mean

Standard Deviation

units on a scale

Baseline, up to 2 hours after first IM injection

ID	Title	Description
OG000	10 mg Olanzapine	Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	10 mg Olanzapine	Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Bradycardia	Cardiac disorders	MedDRA (13.1)	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Chief Medical Officer	Eli Lilly and Company	800-545-5979

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

ID	Term
D012559	Schizophrenia

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.

EG0000 events0 affected45 at risk

EG0011 events1 affected45 at risk