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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


  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


  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