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
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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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

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Other Adverse Events

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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:

	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.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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:

Peuskens J, Porsdal V, Pecenak J, Handest P, D'yachkova Y, Brousil R, Deberdt W. Schizophrenia symptoms and functioning in patients receiving long-term treatment with olanzapine long-acting injection formulation: a pooled analysis. BMC Psychiatry. 2012 Aug 31;12:130. doi: 10.1186/1471-244X-12-130.

McDonnell DP, Detke HC, Bergstrom RF, Kothare P, Johnson J, Stickelmeyer M, Sanchez-Felix MV, Sorsaburu S, Mitchell MI. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, II: investigations of mechanism. BMC Psychiatry. 2010 Jun 10;10:45.

Detke HC, McDonnell DP, Brunner E, Zhao F, Sorsaburu S, Stefaniak VJ, Corya SA. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, I: analysis of cases. BMC Psychiatry. 2010 Jun 10;10:43.

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

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