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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
History of Changes
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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  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 ]
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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 ]
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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 ]
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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 ]
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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 ]
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6.  Primary:   Change From Baseline in Weight at Month 76 Endpoint   [ Time Frame: Baseline, up to 76 months ]
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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 ]
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8.  Primary:   Number of Participants With Extrapyramidal Symptoms at Any Time   [ Time Frame: Randomization to end of study up to 76 months ]
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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 ]
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10.  Secondary:   Change From Baseline in PANSS Positive Scores at Month 76 Endpoint   [ Time Frame: Baseline, up to 76 months ]
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11.  Secondary:   Change From Baseline in PANSS Negative Scores at Month 76 Endpoint   [ Time Frame: Baseline, up to 76 months ]
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12.  Secondary:   Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint   [ Time Frame: Baseline, up to 76 months ]
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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 ]
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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 ]
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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 ]
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16.  Secondary:   Number of Psychiatric Visits   [ Time Frame: Randomization to end of study up to 76 months ]
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17.  Secondary:   Days of Hospitalization   [ Time Frame: Randomization to end of study up to 76 months ]
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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 ]
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19.  Secondary:   Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint   [ Time Frame: Randomization to end of study up to 76 months ]
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20.  Secondary:   Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year   [ Time Frame: Randomization to end of study up to 76 months ]
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  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: NCT00088465     History of Changes
Other Study ID Numbers: 5995, F1D-MC-HGKB
Study First Received: July 26, 2004
Results First Received: October 14, 2011
Last Updated: December 9, 2011
Health Authority: United States: Food and Drug Administration