Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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.
No text entered.

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

Baseline Measures
    Intramuscular Olanzapine Depot  
Number of Participants  
[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 ]

Measure Type Primary
Measure Title Number of Participants With Adverse Events (AE)
Measure Description The list of serious adverse events (SAE) and other non-serious adverse events (AE) are in Adverse Events Section.
Time Frame Randomization to end of study up to 76 months  
Safety Issue Yes  

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.
All randomized participants who took at least one dose of study drug.

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

Measured Values
    Intramuscular Olanzapine Depot  
Number of Participants Analyzed  
[units: participants]
  931  
Number of Participants With Adverse Events (AE)  
[units: participants]
 
AE     501  
SAE     170  

No statistical analysis provided for Number of Participants With Adverse Events (AE)



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 ]

Measure Type Primary
Measure Title Number of Participants With Treatment-Emergent Abnormal High Prolactin at Any Time Post Baseline
Measure Description Prolactin normal reference ranges for female: 2.0 - 29.0 nanograms per milliliter (ng/mL); male: 2.0 - 20.0 ng/mL. High value is defined as a change from a value less than or equal to the high limit at all baseline visits to a value greater than the high limit at any time after baseline.
Time Frame Randomization to end of study up to 76 months  
Safety Issue Yes  

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.
Participants with normal baseline and at least one post-baseline measurement.

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

Measured Values
    Intramuscular Olanzapine Depot  
Number of Participants Analyzed  
[units: participants]
  430  
Number of Participants With Treatment-Emergent Abnormal High Prolactin at Any Time Post Baseline  
[units: participants]
  100  

No statistical analysis provided for Number of Participants With Treatment-Emergent Abnormal High Prolactin at Any Time Post Baseline



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 ]

Measure Type Primary
Measure Title Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline
Measure Description High ALT is defined as a baseline value of <3 times the upper limit of normal (ULN) to ≥3 times the ULN at any time post baseline. High AST is defined as a baseline value of <5 times the ULN to ≥5 times the ULN at any time post baseline. High total bilirubin is defined as a baseline value of <2 times the ULN to ≥2 times the ULN at any time post baseline.
Time Frame Randomization to end of study up to 76 months  
Safety Issue Yes  

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.
Participants with normal baseline and at least one post-baseline measurement.

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

Measured Values
    Intramuscular Olanzapine Depot  
Number of Participants Analyzed  
[units: participants]
  931  
Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline  
[units: participants]
 
ALT (n=901)     61  
AST (n=909)     55  
Total Bilirubin (n=912)     24  

No statistical analysis provided for Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline



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 ]

Measure Type Primary
Measure Title Number of Participants Having Normal Fasting Baseline Glucose Value With Treatment-Emergent High Fasting Glucose at Any Time Post Baseline
Measure Description Normal to high fasting glucose ≤100 milligrams per deciliter (mg/dL) at baseline to ≥126 mg/dL any time post baseline.
Time Frame Randomization to end of study up to 76 months  
Safety Issue Yes  

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.
Participants with normal baseline and at least one post-baseline measurement.

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

Measured Values
    Intramuscular Olanzapine Depot  
Number of Participants Analyzed  
[units: participants]
  864  
Number of Participants Having Normal Fasting Baseline Glucose Value With Treatment-Emergent High Fasting Glucose at Any Time Post Baseline  
[units: participants]
  20  

No statistical analysis provided for Number of Participants Having Normal Fasting Baseline Glucose Value With Treatment-Emergent High Fasting Glucose at Any Time Post Baseline



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 ]

Measure Type Primary
Measure Title Number of Participants Having Normal Fasting Baseline Lipid Value With Treatment-Emergent High Fasting Lipid at Any Time Post Baseline
Measure Description Normal to high fasting total cholesterol ≤200 mg/dL at baseline to ≥240 mg/dL any time post baseline. Fasting triglycerides <150 mg/dL at baseline to ≥200 mg/dL and <500 mg/dL any time post baseline.
Time Frame Randomization to end of study up to 76 months  
Safety Issue Yes  

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.
Participants with normal baseline and at least one post-baseline measurement.

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

Measured Values
    Intramuscular Olanzapine Depot  
Number of Participants Analyzed  
[units: participants]
  931  
Number of Participants Having Normal Fasting Baseline Lipid Value With Treatment-Emergent High Fasting Lipid at Any Time Post Baseline  
[units: participants]
 
Cholesterol (n=873)     28  
Triglycerides (n=879)     41  

No statistical analysis provided for Number of Participants Having Normal Fasting Baseline Lipid Value With Treatment-Emergent High Fasting Lipid at Any Time Post Baseline



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

Measure Type Primary
Measure Title Change From Baseline in Weight at Month 76 Endpoint
Measure Description Mean change in weight from baseline to last observation carried forward (LOCF) endpoint.
Time Frame Baseline, up to 76 months  
Safety Issue Yes  

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.
Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).

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

Measured Values
    Intramuscular Olanzapine Depot  
Number of Participants Analyzed  
[units: participants]
  919  
Change From Baseline in Weight at Month 76 Endpoint  
[units: kilogram (kg)]
Mean ± Standard Deviation
  2.10  ± 7.81  

No statistical analysis provided for Change From Baseline in Weight at Month 76 Endpoint



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 ]

Measure Type Primary
Measure Title Number of Participants With Potentially Clinically Significant (PCS) Weight Gain at Month 76 Endpoint
Measure Description PCS weight gain is defined as a ≥7% increase in weight from baseline.
Time Frame Randomization to end of study up to 76 months  
Safety Issue Yes  

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.
Participants with normal baseline and at least one post-baseline measurement.

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

Measured Values
    Intramuscular Olanzapine Depot  
Number of Participants Analyzed  
[units: participants]
  919  
Number of Participants With Potentially Clinically Significant (PCS) Weight Gain at Month 76 Endpoint  
[units: participants]
  373  

No statistical analysis provided for Number of Participants With Potentially Clinically Significant (PCS) Weight Gain at Month 76 Endpoint



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

Measure Type Primary
Measure Title Number of Participants With Extrapyramidal Symptoms at Any Time
Measure Description Extrapyramidal symptoms are defined as Simpson-Angus total score (SAS) >3 at any post-baseline visit; Barnes Akathisia Scale (BAS) global score ≥2 at any post-baseline visit; A score ≥3 for any of Abnormal Involuntary Movement Scale (AIMS) for items 1-7 or a score ≥2 for any two of these items. Score for SAS is 0-4 for each of the 10 questions, with 0=normal and 4=extreme. The possible total score for SAS is 0-40. Possible score for BAS is 0-5, with 0=absent and 5=sever. Score 0-4 for each item of AIMS, with 0 =none and 4= sever. Possible total score for items 1-7 is 0-28.
Time Frame Randomization to end of study up to 76 months  
Safety Issue Yes  

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.
Participants with a baseline and at least one post-baseline measurement.

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

Measured Values
    Intramuscular Olanzapine Depot  
Number of Participants Analyzed  
[units: participants]
  931  
Number of Participants With Extrapyramidal Symptoms at Any Time  
[units: participants]
 
SAS (n=819)     66  
BAS (n=856)     34  
AIMS (n=860)     28  

No statistical analysis provided for Number of Participants With Extrapyramidal Symptoms at Any Time



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 ]

Measure Type Secondary
Measure Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint
Measure Description Assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210.
Time Frame Baseline, up to 76 months  
Safety Issue No  

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.
Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).

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

Measured Values
    Intramuscular Olanzapine Depot  
Number of Participants Analyzed  
[units: participants]
  856  
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint  
[units: units on a scale]
Mean ± Standard Deviation
  0.30  ± 16.42  

No statistical analysis provided for Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint



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

Measure Type Secondary
Measure Title Change From Baseline in PANSS Positive Scores at Month 76 Endpoint
Measure Description PANSS questions 1-7. Assesses positive symptoms associated with schizophrenia. 7 items make up the positive scale (ex. delusions, conceptual disorganization, and hallucinatory behavior). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total positive subscale scores range from 7 to 49.
Time Frame Baseline, up to 76 months  
Safety Issue No  

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.
Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).

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

Measured Values
    Intramuscular Olanzapine Depot  
Number of Participants Analyzed  
[units: participants]
  856  
Change From Baseline in PANSS Positive Scores at Month 76 Endpoint  
[units: units on a scale]
Mean ± Standard Deviation
  0.21  ± 4.69  

No statistical analysis provided for Change From Baseline in PANSS Positive Scores at Month 76 Endpoint



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

Measure Type Secondary
Measure Title Change From Baseline in PANSS Negative Scores at Month 76 Endpoint
Measure Description PANSS questions 8-14. Assesses negative symptoms associated with schizophrenia. 7 items make up the negative scale (e.g. blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total negative subscale scores range from 7 to 49.
Time Frame Baseline, up to 76 months  
Safety Issue No  

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.
Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).

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

Measured Values
    Intramuscular Olanzapine Depot  
Number of Participants Analyzed  
[units: participants]
  856  
Change From Baseline in PANSS Negative Scores at Month 76 Endpoint  
[units: units on a scale]
Mean ± Standard Deviation
  -0.08  ± 5.14  

No statistical analysis provided for Change From Baseline in PANSS Negative Scores at Month 76 Endpoint



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

Measure Type Secondary
Measure Title Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint
Measure Description PANSS General Psychopathology Subscale is the Remaining 16 PANSS questions or PANSS Question15 through Question 30. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 16 items is defined as the PANSS General Psychopathology Subscales. Possible score ranges from 16 to 112.
Time Frame Baseline, up to 76 months  
Safety Issue No  

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.
Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).

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

Measured Values
    Intramuscular Olanzapine Depot  
Number of Participants Analyzed  
[units: participants]
  856  
Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint  
[units: units on a scale]
Mean ± Standard Deviation
  0.19  ± 8.51  

No statistical analysis provided for Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint



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 ]

Measure Type Secondary
Measure Title Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Scores at Month 72 Endpoint
Measure Description Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Time Frame Baseline, up to 72 months  
Safety Issue No  

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.
Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).

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

Measured Values
    Intramuscular Olanzapine Depot  
Number of Participants Analyzed  
[units: participants]
  920  
Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Scores at Month 72 Endpoint  
[units: units on a scale]
Mean ± Standard Error
  -0.17  ± 0.03  

No statistical analysis provided for Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Scores at Month 72 Endpoint



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 ]

Measure Type Secondary
Measure Title Change From Baseline in the Heinrichs-Carpenter Quality of Life Scale (QLS) Total Score at Month 76 Endpoint
Measure Description Heinrich-Carpenter QLS is an interviewer-rated scale which measures the impact of negative symptoms on occupational, social, and psychological functioning in patients with schizophrenia or schizoaffective disorder. Each of 21 items is rated on a scale from 0 (severely impaired functioning) to 6 (normal or adequate functioning), for a total score range of 0-126. Results are presented as change in Total score.
Time Frame Baseline, up to 76 months  
Safety Issue No  

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.
Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).

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

Measured Values
    Intramuscular Olanzapine Depot  
Number of Participants Analyzed  
[units: participants]
  852  
Change From Baseline in the Heinrichs-Carpenter Quality of Life Scale (QLS) Total Score at Month 76 Endpoint  
[units: units on a scale]
Mean ± Standard Deviation
  6.75  ± 18.55  

No statistical analysis provided for Change From Baseline in the Heinrichs-Carpenter Quality of Life Scale (QLS) Total Score at Month 76 Endpoint



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 ]

Measure Type Secondary
Measure Title Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint
Measure Description A self-reported questionnaire that consists of 36 questions covering 8 health domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The mental component summary (MCS) and the physical component summary (PCS) have been constructed based on the 8 SF-36 domains.
Time Frame Baseline, up to 76 months  
Safety Issue No  

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.
Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).

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

Measured Values
    Intramuscular Olanzapine Depot  
Number of Participants Analyzed  
[units: participants]
  850  
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint  
[units: units on a scale]
Mean ± Standard Deviation
 
Mental component summary     0.94  ± 11.05  
Physical component summary     -0.36  ± 8.34  

No statistical analysis provided for Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint



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

Measure Type Secondary
Measure Title Number of Psychiatric Visits
Measure Description Psychiatric visits were outpatient visits to a psychiatrist or psychiatric nurse.
Time Frame Randomization to end of study up to 76 months  
Safety Issue No  

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.
All randomized participants who took at least one dose of study drug.

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

Measured Values
    Intramuscular Olanzapine Depot  
Number of Participants Analyzed  
[units: participants]
  931  
Number of Psychiatric Visits  
[units: visits]
  14102  

No statistical analysis provided for Number of Psychiatric Visits



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

Measure Type Secondary
Measure Title Days of Hospitalization
Measure Description This is the total number of days for all hospitalized patients that were admitted to General, Psychiatric Ward as well as Intensive Care Unit (ICU).
Time Frame Randomization to end of study up to 76 months  
Safety Issue No  

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.
All randomized participants who took at least one dose of study drug.

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

Measured Values
    Intramuscular Olanzapine Depot  
Number of Participants Analyzed  
[units: participants]
  931  
Days of Hospitalization  
[units: days]
 
Regular hospital     2386  
Psychiatric hospital     35587  
ICU     134  

No statistical analysis provided for Days of Hospitalization



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 ]

Measure Type Secondary
Measure Title Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) at Month 76 Endpoint
Measure Description The Subjective Well-Being under Neuroleptic Treatment-Short Form (SWN-S) is a patient self-rated scale developed to measure the subjective well-being for the previous 7 days of a patient under neuroleptic treatment. The SWN-S consists of 20 items (each item is rated from 1=not at all to 6=very much). Possible total score ranges from 20-120.
Time Frame Baseline, up to 76 months  
Safety Issue No  

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.
Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).

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

Measured Values
    Intramuscular Olanzapine Depot  
Number of Participants Analyzed  
[units: participants]
  755  
Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) at Month 76 Endpoint  
[units: units on a scale]
Mean ± Standard Deviation
  0.86  ± 15.96  

No statistical analysis provided for Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) at Month 76 Endpoint



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

Measure Type Secondary
Measure Title Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint
Measure Description Self-rated scale that measures patient's level of satisfaction with current antipsychotic medication. Consists of 3 items assessing satisfaction with current study medication (scored from 1='very dissatisfied' to 5='very satisfied'), preference comparing current study medication versus previous medications (scored from 1='much prefer previous medication' to 5='much prefer study medication'), and side effects of current study medication compared with previous medications (scored from 1='much less side effects' to 5='much more side effects'). Range of possible scores is 3-15.
Time Frame Randomization to end of study up to 76 months  
Safety Issue No  

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.
All randomized participants.

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

Measured Values
    Intramuscular Olanzapine Depot  
Number of Participants Analyzed  
[units: participants]
  931  
Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint  
[units: percent of participants]
 
Depot, somewhat or very satisfied     73.2  
Depot vs. oral, prefer or much prefer     66.8  
Depot vs. oral, less or much less side effects     73.3  

No statistical analysis provided for Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint



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

Measure Type Secondary
Measure Title Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year
Measure Description Plasma olanzapine concentrations are expressed as (nanogram/milliliter)/(milligram/day) ([ng/mL]/[mg/day]).
Time Frame Randomization to end of study up to 76 months  
Safety Issue Yes  

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.
Participants who took at least one dose of study drug and had post-baseline measurements.

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

Measured Values
    Intramuscular Olanzapine Depot  
Number of Participants Analyzed  
[units: participants]
  931  
Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year  
[units: (ng/mL)/(mg/day)]
Mean ± Standard Deviation
 
0.25 year (n= 130)     2.23  ± 1.34  
1 year (n= 189)     2.51  ± 1.30  
2 years (n= 166)     2.45  ± 1.32  
3 years (n= 148)     2.65  ± 1.39  
4 years (n= 109)     2.57  ± 1.72  
5 years (n= 87)     2.59  ± 1.46  
6 years (n= 28)     2.73  ± 1.25  

No statistical analysis provided for Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year




  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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