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A Study of Olanzapine in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00970281
First received: September 1, 2009
Last updated: March 6, 2012
Last verified: March 2012
History of Changes
Results First Received: January 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: Rapid-Acting Intramuscular Olanzapine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.
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.

Participant Flow:   Overall Study
    10 mg Olanzapine     Placebo  
STARTED     46     45  
Full Analysis Set     45 [1]   45  
COMPLETED     44     29  
NOT COMPLETED     2     16  
Lack of Efficacy                 1                 14  
Withdrawal by Subject                 0                 1  
Physician Decision                 1                 1  
[1] 1 participant in the olanzapine arm discontinued before the first intramuscular (IM) injection.



  Baseline Characteristics
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Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
    10 mg Olanzapine     Placebo     Total  
Number of Participants  
[units: participants]
 		  45     45     90  
Age  
[units: years]
Mean ± Standard Deviation 		  46.4  ± 11.7     47.0  ± 12.1     46.7  ± 11.9  
Gender  
[units: participants]
 		     
Female     21     23     44  
Male     24     22     46  
Region of Enrollment  
[units: participants]
 		     
Japan     45     45     90  
Diabetes Mellitus Status  
[units: participants]
 		     
Diabetes Mellitus - Yes     3     3     6  
Diabetes Mellitus - No     42     42     84  
Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision Diagnosis Status [1]
[units: participants]
 		     
Catatonic     0     2     2  
Disorganized     4     3     7  
Paranoid     40     40     80  
Undifferentiated     1     0     1  
Residual     0     0     0  
Pre-therapy Antipsychotic Usage  
[units: participants]
 		     
Yes (>=1000 milligrams [mg])     12     11     23  
Yes (<1000 mg)     27     30     57  
No     6     4     10  
Age at Onset  
[units: years]
Mean ± Standard Deviation 		  24.7  ± 9.4     27.2  ± 9.3     25.9  ± 9.4  
Agitation-Calmness Evaluation Scale (ACES) Score [2]
[units: units on a scale]
Mean ± Standard Deviation 		  1.6  ± 0.5     1.6  ± 0.5     1.6  ± 0.5  
Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) Total Score [3]
[units: units on a scale]
Mean ± Standard Deviation 		  23.5  ± 6.1     23.2  ± 4.9     23.4  ± 5.5  
[1] Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision (DSM-IV-TR) diagnosis status.
[2] The ACES differentiates agitation, calmness, and sleep-state, using a 9-point scale: 1 (Marked Agitation) to 9 (Unarousable).
[3] 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.



  Outcome Measures
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1.  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   [ Time Frame: Baseline, up to 2 hours after first IM injection ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in PANSS-EC Total Score up to 90 Minutes After the First Intramuscular (IM) Injection   [ Time Frame: Baseline, 15 minutes, 30 minutes, 60 minutes, and 90 minutes after the first injection ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) Total Score up to 24 Hours After the First Intramuscular (IM) Injection   [ Time Frame: Baseline, up to 24 hours after first IM injection ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Participants With 40% or Greater Percent Decrease in the Positive and Negative Syndrome Scale - Excited Component (PANSS-EC) Total Score up to 2 Hours After the First Intramuscular (IM) Injection   [ Time Frame: Up to 2 hours after the first (IM) injection ]
  Show Outcome Measure 4

5.  Secondary:   Percentage of Participants With Scores of 4 to 7 in the Agitation-Calmness Evaluation Scale (ACES) Score up to 24 Hours After the First Intramuscular (IM) Injection   [ Time Frame: up to 24 hours after the first IM injection ]
  Show Outcome Measure 5

6.  Secondary:   Percentage of Participants With Treatment-Emergent Extrapyramidal Symptoms Based on the Drug Induced Extrapyramidal Symptoms Scale (DIEPSS) Score up to 24 Hours After the First Intramuscular (IM) Injection   [ Time Frame: Up to 24 hours after the first IM injection ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided by Eli Lilly and Company

Publications automatically indexed to this study:


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00970281     History of Changes
Other Study ID Numbers: 13333, F1D-JE-RACD
Study First Received: September 1, 2009
Results First Received: January 18, 2012
Last Updated: March 6, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare