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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00640510
First received: March 18, 2008
Last updated: August 26, 2009
Last verified: August 2009
Results First Received: July 16, 2009  
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: Isotonic sodium chloride solution

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One patient randomized to placebo was withdrawn from study by physician and is not included in the baseline demographic data table.

Reporting Groups
  Description
IM Olanzapine 10mg Patients will receive at least one injection of Intramuscular 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).
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).

Participant Flow:   Overall Study
    IM Olanzapine 10mg     IM Placebo  
STARTED     17     17 [1]
COMPLETED     16     15  
NOT COMPLETED     1     2  
Lack of Efficacy                 0                 1  
Protocol Violation                 1                 0  
Physician Decision                 0                 1  
[1] One patient randomized to placebo discontinued prior to receiving study drug.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
IM Olanzapine 10mg Patients will receive at least one injection of Intramuscular 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).
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).
Total Total of all reporting groups

Baseline Measures
    IM Olanzapine 10mg     IM Placebo     Total  
Number of Participants  
[units: participants]
  17     16     33  
Age  
[units: years]
Mean ± Standard Deviation
  47.4  ± 12.4     45.9  ± 11.5     46.7  ± 11.8  
Gender  
[units: participants]
     
Female     8     6     14  
Male     9     10     19  
Region of Enrollment  
[units: participants]
     
Japan     17     16     33  
Diabetes Mellitus  
[units: participants]
     
Yes     2     2     4  
No     15     14     29  
Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision Diagnosis  
[units: participants]
     
Catatonic     2     0     2  
Disorganized     7     7     14  
Paranoid     7     7     14  
Undifferentiated     1     0     1  
Residual     0     2     2  
Pre-Therapy Antipsychotic Usage  
[units: participants]
     
Yes (>=1000 milligrams/day)     7     6     13  
Yes (<1000 milligrams/day)     9     9     18  
No     1     1     2  
Age at Onset  
[units: years]
Mean ± Standard Deviation
  22.6  ± 6.4     21.3  ± 6.1     22.0  ± 6.2  
Agitation-Calmness Evaluation Scale (ACES) [1]
[units: units on a scale]
Mean ± Standard Deviation
  1.8  ± 0.4     1.8  ± 0.4     1.8  ± 0.4  
Body Mass Index (BMI) [2]
[units: kilograms/square centimeters]
Mean ± Standard Deviation
  20.7  ± 2.9     22.8  ± 3.6     21.7  ± 3.3  
Positive and Negative Syndrome Scale-Excited Component [3]
[units: units on a scale]
Mean ± Standard Deviation
  23.6  ± 3.8     23.5  ± 3.8     23.5  ± 3.7  
[1] The ACES differentiates agitation, calmness, and sleep-state, using a 9-point scale: 1 (Marked Agitation) to 9 (Unarousable).
[2] Body mass index is an estimate of body fat based on body weight divided by height squared.
[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 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 ]

2.  Secondary:   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 ]

3.  Secondary:   Number of Responders at 2 Hours After First Intramuscular (IM) Injection   [ Time Frame: 2 hours post first IM injection ]

4.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided


Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00640510     History of Changes
Other Study ID Numbers: 9622, F1D-JE-RA03
Study First Received: March 18, 2008
Results First Received: July 16, 2009
Last Updated: August 26, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare