Schizoaffective Disorder, Schizophrenic Disorders
Conditions
Brief summary
This is a long-term, open-label clinical study designed to enable longer-term treatment of patients completing other clinical studies with intramuscular olanzapine depot. Key objectives of the study are to: * Determine how well intramuscular (IM) olanzapine depot works during long-term treatment, * Evaluate the safety and tolerability of IM olanzapine depot during long-term treatment, * Determine the blood levels of IM olanzapine depot in patients during long-term treatment
Interventions
45-405 milligram (mg), intramuscular injection, on a 2-, 3-, or 4-week interval.
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 76 Years
Healthy volunteers
No
Inclusion criteria
* Patients must have schizophrenia * Female patients of childbearing potential must be using a medically accepted means of contraception * Patients must have completed (within 10 days) another IM olanzapine depot study if permitted by that study's protocol.
Exclusion criteria
* Patients must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to study entry * Female patients must not be pregnant or breast-feeding * Patients must not be experiencing acute, serious or unstable medical conditions other than schizophrenia or schizoaffective disorder * Patients must not have a substance (except nicotine or caffeine) dependence within the past 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AE) | Randomization to end of study up to 76 months | The list of serious adverse events (SAE) and other non-serious adverse events (AE) are in Adverse Events Section. |
| Number of Participants With Treatment-Emergent Abnormal High Prolactin at Any Time Post Baseline | Randomization to end of study up to 76 months | 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. |
| Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline | Randomization to end of study up to 76 months | 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. |
| Number of Participants Having Normal Fasting Baseline Glucose Value With Treatment-Emergent High Fasting Glucose at Any Time Post Baseline | Randomization to end of study up to 76 months | Normal to high fasting glucose ≤100 milligrams per deciliter (mg/dL) at baseline to ≥126 mg/dL any time post baseline. |
| Number of Participants Having Normal Fasting Baseline Lipid Value With Treatment-Emergent High Fasting Lipid at Any Time Post Baseline | Randomization to end of study up to 76 months | 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. |
| Change From Baseline in Weight at Month 76 Endpoint | Baseline, up to 76 months | Mean change in weight from baseline to last observation carried forward (LOCF) endpoint. |
| Number of Participants With Potentially Clinically Significant (PCS) Weight Gain at Month 76 Endpoint | Randomization to end of study up to 76 months | PCS weight gain is defined as a ≥7% increase in weight from baseline. |
| Number of Participants With Extrapyramidal Symptoms at Any Time | Randomization to end of study up to 76 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days of Hospitalization | Randomization to end of study up to 76 months | 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). |
| Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) at Month 76 Endpoint | Baseline, up to 76 months | 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. |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint | Baseline, up to 76 months | 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. |
| Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year | Randomization to end of study up to 76 months | Plasma olanzapine concentrations are expressed as (nanogram/milliliter)/(milligram/day) (\[ng/mL\]/\[mg/day\]). |
| Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint | Randomization to end of study up to 76 months | 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. |
| Change From Baseline in PANSS Positive Scores at Month 76 Endpoint | Baseline, up to 76 months | 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. |
| Change From Baseline in PANSS Negative Scores at Month 76 Endpoint | Baseline, up to 76 months | 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. |
| Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint | Baseline, up to 76 months | 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. |
| Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Scores at Month 72 Endpoint | Baseline, up to 72 months | 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). |
| Change From Baseline in the Heinrichs-Carpenter Quality of Life Scale (QLS) Total Score at Month 76 Endpoint | Baseline, up to 76 months | 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. |
| Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint | Baseline, up to 76 months | 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. |
| Number of Psychiatric Visits | Randomization to end of study up to 76 months | Psychiatric visits were outpatient visits to a psychiatrist or psychiatric nurse. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Croatia, Czechia, France, Germany, Hungary, Israel, Italy, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Taiwan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intramuscular Olanzapine Depot Intramuscular (IM) olanzapine depot flexible dosing and flexible interval | 931 |
| Total | 931 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 77 |
| Overall Study | Death | 11 |
| Overall Study | Lack of Efficacy | 27 |
| Overall Study | Lost to Follow-up | 57 |
| Overall Study | Physician Decision | 45 |
| Overall Study | Protocol Violation | 17 |
| Overall Study | Sponsor Decision | 37 |
| Overall Study | Withdrawal by Subject | 290 |
Baseline characteristics
| Characteristic | Intramuscular Olanzapine Depot |
|---|---|
| Age Continuous | 39.32 years STANDARD_DEVIATION 11.67 |
| Race/Ethnicity, Customized African | 102 participants |
| Race/Ethnicity, Customized Caucasian | 629 participants |
| Race/Ethnicity, Customized East Asian | 39 participants |
| Race/Ethnicity, Customized Hispanic | 140 participants |
| Race/Ethnicity, Customized Native American | 2 participants |
| Race/Ethnicity, Customized West Asian | 19 participants |
| Region of Enrollment Argentina | 73 participants |
| Region of Enrollment Australia | 11 participants |
| Region of Enrollment Austria | 10 participants |
| Region of Enrollment Belgium | 13 participants |
| Region of Enrollment Brazil | 89 participants |
| Region of Enrollment Croatia | 16 participants |
| Region of Enrollment Czech Republic | 3 participants |
| Region of Enrollment France | 55 participants |
| Region of Enrollment Germany | 32 participants |
| Region of Enrollment Greece | 3 participants |
| Region of Enrollment Hungary | 13 participants |
| Region of Enrollment Israel | 29 participants |
| Region of Enrollment Italy | 6 participants |
| Region of Enrollment Mexico | 63 participants |
| Region of Enrollment Netherlands | 8 participants |
| Region of Enrollment Poland | 33 participants |
| Region of Enrollment Portugal | 18 participants |
| Region of Enrollment Puerto Rico | 27 participants |
| Region of Enrollment Romania | 34 participants |
| Region of Enrollment Russian Federation | 114 participants |
| Region of Enrollment Slovakia | 13 participants |
| Region of Enrollment South Africa | 28 participants |
| Region of Enrollment Spain | 24 participants |
| Region of Enrollment Sweden | 9 participants |
| Region of Enrollment Taiwan | 30 participants |
| Region of Enrollment United States | 177 participants |
| Sex: Female, Male Female | 310 Participants |
| Sex: Female, Male Male | 621 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 501 / 931 |
| serious Total, serious adverse events | 170 / 931 |
Outcome results
Primary
Change From Baseline in Weight at Month 76 Endpoint
Mean change in weight from baseline to last observation carried forward (LOCF) endpoint.
Time frame: Baseline, up to 76 months
Population: Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intramuscular Olanzapine Depot | Change From Baseline in Weight at Month 76 Endpoint | 2.10 kilogram (kg) | Standard Deviation 7.81 |
Primary
Number of Participants Having Normal Fasting Baseline Glucose Value With Treatment-Emergent High Fasting Glucose at Any Time Post Baseline
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
Population: Participants with normal baseline and at least one post-baseline measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intramuscular Olanzapine Depot | Number of Participants Having Normal Fasting Baseline Glucose Value With Treatment-Emergent High Fasting Glucose at Any Time Post Baseline | 20 participants |
Primary
Number of Participants Having Normal Fasting Baseline Lipid Value With Treatment-Emergent High Fasting Lipid at Any Time Post Baseline
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
Population: Participants with normal baseline and at least one post-baseline measurement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intramuscular Olanzapine Depot | Number of Participants Having Normal Fasting Baseline Lipid Value With Treatment-Emergent High Fasting Lipid at Any Time Post Baseline | Cholesterol (n=873) | 28 participants |
| Intramuscular Olanzapine Depot | Number of Participants Having Normal Fasting Baseline Lipid Value With Treatment-Emergent High Fasting Lipid at Any Time Post Baseline | Triglycerides (n=879) | 41 participants |
Primary
Number of Participants With Adverse Events (AE)
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
Population: All randomized participants who took at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intramuscular Olanzapine Depot | Number of Participants With Adverse Events (AE) | AE | 501 participants |
| Intramuscular Olanzapine Depot | Number of Participants With Adverse Events (AE) | SAE | 170 participants |
Primary
Number of Participants With Extrapyramidal Symptoms at Any Time
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
Population: Participants with a baseline and at least one post-baseline measurement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intramuscular Olanzapine Depot | Number of Participants With Extrapyramidal Symptoms at Any Time | SAS (n=819) | 66 participants |
| Intramuscular Olanzapine Depot | Number of Participants With Extrapyramidal Symptoms at Any Time | BAS (n=856) | 34 participants |
| Intramuscular Olanzapine Depot | Number of Participants With Extrapyramidal Symptoms at Any Time | AIMS (n=860) | 28 participants |
Primary
Number of Participants With Potentially Clinically Significant (PCS) Weight Gain at Month 76 Endpoint
PCS weight gain is defined as a ≥7% increase in weight from baseline.
Time frame: Randomization to end of study up to 76 months
Population: Participants with normal baseline and at least one post-baseline measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intramuscular Olanzapine Depot | Number of Participants With Potentially Clinically Significant (PCS) Weight Gain at Month 76 Endpoint | 373 participants |
Primary
Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline
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
Population: Participants with normal baseline and at least one post-baseline measurement.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intramuscular Olanzapine Depot | Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline | ALT (n=901) | 61 participants |
| Intramuscular Olanzapine Depot | Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline | AST (n=909) | 55 participants |
| Intramuscular Olanzapine Depot | Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline | Total Bilirubin (n=912) | 24 participants |
Primary
Number of Participants With Treatment-Emergent Abnormal High Prolactin at Any Time Post Baseline
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
Population: Participants with normal baseline and at least one post-baseline measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intramuscular Olanzapine Depot | Number of Participants With Treatment-Emergent Abnormal High Prolactin at Any Time Post Baseline | 100 participants |
Secondary
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint
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
Population: Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intramuscular Olanzapine Depot | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint | Mental component summary | 0.94 units on a scale | Standard Deviation 11.05 |
| Intramuscular Olanzapine Depot | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint | Physical component summary | -0.36 units on a scale | Standard Deviation 8.34 |
Secondary
Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Scores at Month 72 Endpoint
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
Population: Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intramuscular Olanzapine Depot | Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Scores at Month 72 Endpoint | -0.17 units on a scale | Standard Error 0.03 |
Secondary
Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint
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
Population: Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intramuscular Olanzapine Depot | Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint | 0.19 units on a scale | Standard Deviation 8.51 |
Secondary
Change From Baseline in PANSS Negative Scores at Month 76 Endpoint
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
Population: Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intramuscular Olanzapine Depot | Change From Baseline in PANSS Negative Scores at Month 76 Endpoint | -0.08 units on a scale | Standard Deviation 5.14 |
Secondary
Change From Baseline in PANSS Positive Scores at Month 76 Endpoint
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
Population: Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intramuscular Olanzapine Depot | Change From Baseline in PANSS Positive Scores at Month 76 Endpoint | 0.21 units on a scale | Standard Deviation 4.69 |
Secondary
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint
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
Population: Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intramuscular Olanzapine Depot | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint | 0.30 units on a scale | Standard Deviation 16.42 |
Secondary
Change From Baseline in the Heinrichs-Carpenter Quality of Life Scale (QLS) Total Score at Month 76 Endpoint
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
Population: Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intramuscular Olanzapine Depot | Change From Baseline in the Heinrichs-Carpenter Quality of Life Scale (QLS) Total Score at Month 76 Endpoint | 6.75 units on a scale | Standard Deviation 18.55 |
Secondary
Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) at Month 76 Endpoint
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
Population: Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intramuscular Olanzapine Depot | Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) at Month 76 Endpoint | 0.86 units on a scale | Standard Deviation 15.96 |
Secondary
Days of Hospitalization
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
Population: All randomized participants who took at least one dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intramuscular Olanzapine Depot | Days of Hospitalization | Regular hospital | 2386 days |
| Intramuscular Olanzapine Depot | Days of Hospitalization | Psychiatric hospital | 35587 days |
| Intramuscular Olanzapine Depot | Days of Hospitalization | ICU | 134 days |
Secondary
Number of Psychiatric Visits
Psychiatric visits were outpatient visits to a psychiatrist or psychiatric nurse.
Time frame: Randomization to end of study up to 76 months
Population: All randomized participants who took at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intramuscular Olanzapine Depot | Number of Psychiatric Visits | 14102 visits |
Secondary
Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint
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
Population: All randomized participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intramuscular Olanzapine Depot | Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint | Depot vs. oral, prefer or much prefer | 66.8 percent of participants |
| Intramuscular Olanzapine Depot | Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint | Depot vs. oral, less or much less side effects | 73.3 percent of participants |
| Intramuscular Olanzapine Depot | Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint | Depot, somewhat or very satisfied | 73.2 percent of participants |
Secondary
Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year
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
Population: Participants who took at least one dose of study drug and had post-baseline measurements.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intramuscular Olanzapine Depot | Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year | 0.25 year (n= 130) | 2.23 (ng/mL)/(mg/day) | Standard Deviation 1.34 |
| Intramuscular Olanzapine Depot | Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year | 3 years (n= 148) | 2.65 (ng/mL)/(mg/day) | Standard Deviation 1.39 |
| Intramuscular Olanzapine Depot | Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year | 4 years (n= 109) | 2.57 (ng/mL)/(mg/day) | Standard Deviation 1.72 |
| Intramuscular Olanzapine Depot | Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year | 5 years (n= 87) | 2.59 (ng/mL)/(mg/day) | Standard Deviation 1.46 |
| Intramuscular Olanzapine Depot | Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year | 1 year (n= 189) | 2.51 (ng/mL)/(mg/day) | Standard Deviation 1.3 |
| Intramuscular Olanzapine Depot | Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year | 2 years (n= 166) | 2.45 (ng/mL)/(mg/day) | Standard Deviation 1.32 |
| Intramuscular Olanzapine Depot | Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year | 6 years (n= 28) | 2.73 (ng/mL)/(mg/day) | Standard Deviation 1.25 |