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Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00088465
First received: July 26, 2004
Last updated: December 9, 2011
Last verified: December 2011
Results First Received: October 14, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Schizophrenic Disorders
Schizoaffective Disorder
Intervention: Drug: Intramuscular olanzapine depot

  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
Intramuscular Olanzapine Depot Intramuscular (IM) olanzapine depot flexible dosing and flexible interval

Participant Flow:   Overall Study
    Intramuscular Olanzapine Depot
STARTED   931 
COMPLETED   370 
NOT COMPLETED   561 
Withdrawal by Subject                290 
Adverse Event                77 
Lost to Follow-up                57 
Physician Decision                45 
Sponsor Decision                37 
Lack of Efficacy                27 
Protocol Violation                17 
Death                11 



  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.
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Reporting Groups
  Description
Intramuscular Olanzapine Depot Intramuscular (IM) olanzapine depot flexible dosing and flexible interval

Baseline Measures
   Intramuscular Olanzapine Depot 
Overall Participants Analyzed 
[Units: Participants]
 931 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.32  (11.67) 
Gender 
[Units: Participants]
 
Female   310 
Male   621 
Race/Ethnicity, Customized 
[Units: Participants]
 
African   102 
Caucasian   629 
East Asian   39 
Hispanic   140 
Native American   2 
West Asian   19 
Region of Enrollment 
[Units: Participants]
 
United States   177 
Portugal   18 
Taiwan   30 
Slovakia   13 
Spain   24 
Russian Federation   114 
Israel   29 
Italy   6 
France   55 
Puerto Rico   27 
Australia   11 
South Africa   28 
Netherlands   8 
Austria   10 
Czech Republic   3 
Hungary   13 
Mexico   63 
Argentina   73 
Poland   33 
Brazil   89 
Belgium   13 
Croatia   16 
Romania   34 
Germany   32 
Sweden   9 
Greece   3 


  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events (AE)   [ Time Frame: Randomization to end of study up to 76 months ]

2.  Primary:   Number of Participants With Treatment-Emergent Abnormal High Prolactin at Any Time Post Baseline   [ Time Frame: Randomization to end of study up to 76 months ]

3.  Primary:   Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline   [ Time Frame: Randomization to end of study up to 76 months ]

4.  Primary:   Number of Participants Having Normal Fasting Baseline Glucose Value With Treatment-Emergent High Fasting Glucose at Any Time Post Baseline   [ Time Frame: Randomization to end of study up to 76 months ]

5.  Primary:   Number of Participants Having Normal Fasting Baseline Lipid Value With Treatment-Emergent High Fasting Lipid at Any Time Post Baseline   [ Time Frame: Randomization to end of study up to 76 months ]

6.  Primary:   Change From Baseline in Weight at Month 76 Endpoint   [ Time Frame: Baseline, up to 76 months ]

7.  Primary:   Number of Participants With Potentially Clinically Significant (PCS) Weight Gain at Month 76 Endpoint   [ Time Frame: Randomization to end of study up to 76 months ]

8.  Primary:   Number of Participants With Extrapyramidal Symptoms at Any Time   [ Time Frame: Randomization to end of study up to 76 months ]

9.  Secondary:   Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint   [ Time Frame: Baseline, up to 76 months ]

10.  Secondary:   Change From Baseline in PANSS Positive Scores at Month 76 Endpoint   [ Time Frame: Baseline, up to 76 months ]

11.  Secondary:   Change From Baseline in PANSS Negative Scores at Month 76 Endpoint   [ Time Frame: Baseline, up to 76 months ]

12.  Secondary:   Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint   [ Time Frame: Baseline, up to 76 months ]

13.  Secondary:   Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Scores at Month 72 Endpoint   [ Time Frame: Baseline, up to 72 months ]

14.  Secondary:   Change From Baseline in the Heinrichs-Carpenter Quality of Life Scale (QLS) Total Score at Month 76 Endpoint   [ Time Frame: Baseline, up to 76 months ]

15.  Secondary:   Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint   [ Time Frame: Baseline, up to 76 months ]

16.  Secondary:   Number of Psychiatric Visits   [ Time Frame: Randomization to end of study up to 76 months ]

17.  Secondary:   Days of Hospitalization   [ Time Frame: Randomization to end of study up to 76 months ]

18.  Secondary:   Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) at Month 76 Endpoint   [ Time Frame: Baseline, up to 76 months ]

19.  Secondary:   Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint   [ Time Frame: Randomization to end of study up to 76 months ]

20.  Secondary:   Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year   [ Time Frame: Randomization to end of study up to 76 months ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5  

Reporting Groups
  Description
Intramuscular Olanzapine Depot Intramuscular (IM) olanzapine depot flexible dosing and flexible interval

Other Adverse Events
    Intramuscular Olanzapine Depot
Total, other (not including serious) adverse events   
# participants affected / at risk   501/931 (53.81%) 
Infections and infestations   
Nasopharyngitis † 1   
# participants affected / at risk   74/931 (7.95%) 
# events   84 
Investigations   
Weight increased † 1   
# participants affected / at risk   134/931 (14.39%) 
# events   136 
Nervous system disorders   
Dizziness † 1   
# participants affected / at risk   50/931 (5.37%) 
# events   57 
Headache † 1   
# participants affected / at risk   67/931 (7.20%) 
# events   72 
Somnolence † 1   
# participants affected / at risk   85/931 (9.13%) 
# events   101 
Psychiatric disorders   
Anxiety † 1   
# participants affected / at risk   90/931 (9.67%) 
# events   94 
Depression † 1   
# participants affected / at risk   48/931 (5.16%) 
# events   48 
Insomnia † 1   
# participants affected / at risk   90/931 (9.67%) 
# events   92 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 13.1



  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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