A Phase 3 interventional study of olanzapine and olanzapine pamoate depot in Schizophrenia, sponsored by Eli Lilly and Company. Completed at 49 sites in 12 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-01-23.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
To compare the health outcome of patients with schizophrenia, who are at risk for relapse, when treated with a long acting injection form of olanzapine versus treatment with oral olanzapine.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 524 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
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Exclusion Criteria:
Olanzapine pamoate depot
Drug: olanzapine pamoate depot
Oral olanzapine
Drug: olanzapine
10 milligrams (mg), oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
Also known as: LY170053, Zyprexa
405 milligrams (mg), intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
Median Time to Discontinuation for Any Reason (Excluding Sponsor Decision)
Time frame: Baseline up to 104 weeks
Change From Baseline in Heinrich-Carpenter Quality of Life in Schizophrenia Scale (QLS) Total Score at 104 Weeks
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). Total score range is 0-126. Least Squares Mean (LS Mean) values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline.
Time frame: Baseline, 104 weeks
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores
SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains. Domains and scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30. There are 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). MCS and PCS scores=0-100 (higher scores indicate better health status). LS Mean values were adjusted for investigator and treatment at baseline; change values were also adjusted for baseline.
Time frame: Baseline, 104 weeks
Change From Baseline in Overall Health Status Assessment Using the EuroQol: 5 Dimensions Questionnaire (EQ-5D) at 104 Weeks
Generic, multidimensional, health-related, quality-of-life instrument. Overall health status is self-reported using a visual analogue scale marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. LS Mean values were adjusted for investigator and treatment at baseline; change values were also adjusted for baseline.
Time frame: Baseline, 104 weeks
Change From Baseline in Burden Assessment Scale (BAS) Total Score at 104 Weeks
Self-rated scale completed by patient's caregiver which measures level of burden placed on the caregiver by caring for the patient. Each of 19 items is rated on a scale from 0 (no impact) to 3 (high negative impact). Total Score range is 0-57. If any of the 19 questions were answered "not applicable", then a Total Score of 9 was entered. LS Mean values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline.
Time frame: Baseline, 104 weeks
Resource Utilization: Number of Outpatient Physician Visits During the Study
Number of outpatient physician visits during the study, post-baseline through 104 weeks.
Time frame: Baseline through 104 weeks
Resource Utilization: Days of Unpaid Care, Days of Workdays Missed, Days of Paid Care Per Week During the Study
Number of days of unpaid care, number of days of workdays missed, number of days of paid care per week during the study, post-baseline through 104 weeks.
Time frame: Baseline through 104 weeks
Number of Hospitalization Days
Mean - calculated based on total number of hospitalization days per patient within reporting interval.
Time frame: Baseline through 104 weeks
Change From Baseline in Scale to Assess Unawareness of Mental Disorder (SUMD) Total Score at 104 Weeks
Interviewer-rated scale that assesses patients' awareness of and insight into their illness. SUMD can either be based on 4 items or 5 items. Items 1 through 4 are rated from 1 (aware) to 5 (unaware); item 5 assesses correct attribution of symptoms to a mental disorder and is rated from 1 (symptoms correctly attributed) to 5 (symptoms incorrectly attributed). Total Scores for Items (1-4) range from 4 to 20 and Total Scores for Items (1-5) range from 5 to 25. LS Mean values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline.
Time frame: Baseline, 104 weeks
Change From Baseline in Working Alliance Inventory (WAI) Total Score at 104 Weeks
Self-rated scale assessing patients' level of alliance with their therapist, including agreement on goals, tasks, and emotional bond. Each of 12 items is rated from 1 ('never') to 7 ('always'), with higher scores indicating greater alliance. Total Scores range from 12-84. LS Mean values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline.
Time frame: Baseline, 104 weeks
Change From Baseline in Schizophrenia Objective Functioning Instrument (SOFI) Global Score at 104 Weeks
Interviewer-rated 49-item scale used to assess 4 functional domains in patients with schizophrenia : 1) living situation, 2) instrumental activities of daily living, 3) productive activities and role functioning, and 4) social/recreational functioning. Possible responses and scoring vary by item and by domain, with higher scores representing better functioning. Range of possible scores is 1-100. LS Mean values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline.
Time frame: Baseline, 104 weeks
Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at 104 Weeks (All Items)
Self-rated scale which 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: 104 weeks
Patient Attitude Toward Treatment Using the Drug Attitude Inventory (DAI) Scale Total Score at 104 Weeks
Self-rated scale which measures patient's subjective feelings about taking medications. Each of 10 items is rated as true or false. For items 1, 3, 4, 6, 7, 9, and 10, true is scored as 1; false is scored as 0. For items 2, 5, and 8, true is scored as 0; false is scored as 1. Possible total scores range from 0-10. A subject who answers all 10 questions false will have a score of 3; a subject who answers all 10 questions true will have a score of 7. For 7 out of 10 questions, false is represented by 0, the other 3 questions false is represented by a value=1.
Time frame: 104 weeks
Number of Participants With All-Cause Discontinuations (Excluding Sponsor Decision)
Number of participants who discontinued study participation for any reason (excluding sponsor decision).
Time frame: Baseline through 104 weeks
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Scores at 104 Weeks
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, 104 weeks
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total and Subscale Scores at 104 Weeks
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, 104 weeks
Median Time to Relapse
Relapse is defined as any 1 of the following: 1) hospitalization for symptoms related to schizophrenia; 2) increase of 25% from baseline in PANSS total score (range:30-210) (if baseline score was \>40) or increase of 10 points (if baseline score was ≤40), and ≥1-point increase from baseline on CGI-S score (range:1-7), provided that increase results in CGI-S ≥4; 3) deliberate self-injury or injury to others deemed clinically to be associated with worsening of psychosis; 4) discontinuation from the study because of worsening of psychosis. On PANSS and CGI-S higher scores indicate greater illness.
Time frame: Baseline to time of relapse (up to 104 weeks)
Number of Participants Experiencing Relapse
Relapse is defined as any one of the following: 1) hospitalization for symptoms related to schizophrenia; 2) an increase of 25% from baseline in the total score on the PANSS (if the baseline score was \>40), or an increase of 10 points (if baseline score was \<=40) and \>=1-point increase from baseline score on the CGI-S score, provided that the increase results in a CGI-S score \>=4; 3) deliberate self-injury or injury to others that is deemed clinically to be associated with worsening of psychosis; 4) discontinuation from the study because of worsening of psychosis.
Time frame: Baseline through 104 weeks
Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score at 104 Weeks
BPRS is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. For this study, the BPRS total score was derived from 18 PANSS questions. To calculate the score, the score of the 18 questions was added then 18 was subtracted from the total. As an example, if a subject had a score=1 (absent) on all 18 items, the resulting total=zero. Responses range from 0 (absent) to 6 (extremely severe); the Total Score range is 0-108.
Time frame: Baseline, 104 weeks
Resource Utilization: Number of Outpatient Surgeries During the Study, 24 Months After Randomization
Number of outpatient surgeries during the study, post-baseline through 104 weeks.
Time frame: Baseline through 104 Weeks
Change From Baseline in Weight at 104 Weeks
Time frame: Baseline, 104 weeks
Participants With Potentially Clinically Significant (PCS) Weight Gain at 104 Weeks
PCS weight gain is defined as a \>=7% increase in weight from baseline at 104 weeks.
Time frame: Baseline, 104 weeks
Participants With Normal to High Fasting Glucose, Fasting Total Cholesterol, and Fasting Triglycerides
Normal to high fasting glucose = \<100 milligrams per deciliter (mg/dL) baseline; \>=126 mg/dL any time post baseline (or endpoint). Normal to high fasting total cholesterol =\<200 mg/dL baseline; \>=240 mg/dL any time post baseline or endpoint. Fasting triglycerides \<150 mg/dL baseline; \>=200 mg/dL and \<500 mg/dL any time post baseline or endpoint.
Time frame: Baseline through 104 weeks
Participants With Treatment-Emergent Abnormal High Prolactin at 104 Weeks
The prolactin reference Range is: Female: 2.0 - 29.0 nanograms per milliliter (ng/mL); Male: 2.0 - 20.0 ng/mL. A treatment-emergent abnormally 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: Baseline, 104 weeks
Participants With Treatment-Emergent High Alanine Transaminase (ALT), Aspartate Transaminase (AST), and Total Bilirubin
Treatment-emergent (TE) high ALT is defined as a baseline value of \<3 times the upper limit of normal (ULN) to \>=3 times the ULN at endpoint. TE high AST is defined as a baseline value of \<5 times the ULN to \>=5 times the ULN at endpoint. TE high total bilirubin is defined as a baseline value of \<2 times the ULN to \>=2 times the ULN at endpoint. Hy's Rule is defined as ALT \>=3 times the ULN and total bilirubin \>=2 times the ULN.
Time frame: Baseline through 104 Weeks
Participants Discontinuing Because of an Adverse Event (AE) or Death
Time frame: Baseline through 104 weeks
| Milestone | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| Started | 264 | 260 |
| Completed | 119 | 124 |
| Not completed | 145 | 136 |
| Withdrew: Adverse event | 26 | 25 |
| Withdrew: Clinical relapse | 26 | 20 |
| Withdrew: Death | 0 | 2 |
| Withdrew: Entry criteria exclusion | 2 | 4 |
| Withdrew: Lack of efficacy | 16 | 7 |
| Withdrew: Lost to follow-up | 21 | 22 |
| Withdrew: Physician decision | 8 | 8 |
| Withdrew: Protocol violation | 4 | 4 |
| Withdrew: Sponsor decision | 3 | 3 |
| Withdrew: Withdrawal by subject | 39 | 41 |
| Days | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| Median Time to Discontinuation for Any Reason (Excluding Sponsor Decision) | 644.50 (162.00 to 740.00) | 677.50 (169.50 to 740.00) |
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). Total score range is 0-126. Least Squares Mean (LS Mean) values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline.
| Units on a Scale | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| Baseline (n=193,193) | 60.09 ± 1.79 | 57.73 ± 1.80 |
| Change from Baseline at Week 104 (n=130,135) | 8.15 ± 1.57 | 7.24 ± 1.56 |
SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains. Domains and scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30. There are 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). MCS and PCS scores=0-100 (higher scores indicate better health status). LS Mean values were adjusted for investigator and treatment at baseline; change values were also adjusted for baseline.
| Units on a Scale | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| Mental Score Detail at Baseline (n=188,193) | 42.12 ± 1.02 | 40.56 ± 1.01 |
| Mental Score Detail Change at Week 104 (n=124,134) | 4.87 ± 0.89 | 4.52 ± 0.87 |
| Physical Score Detail at Baseline (n=188,193) | 47.80 ± 0.73 | 47.91 ± 0.72 |
| Physical Score Detail Change Week 104 (n=124,134) | 0.43 ± 0.75 | 0.84 ± 0.73 |
| Physical Functioning at Baseline (n=193,194) | 76.18 ± 2.02 | 75.63 ± 2.03 |
| Physical Functioning Change Week 104 (n=129,134) | 1.35 ± 1.89 | 2.44 ± 1.87 |
| Role-Physical at Baseline (n=192,194) | 63.60 ± 3.42 | 60.74 ± 3.43 |
| Role-Physical Change at Week 104 (n=130,134) | 10.70 ± 3.42 | 13.76 ± 3.38 |
| Mental Health at Baseline (n=192,194) | 61.18 ± 1.84 | 60.10 ± 1.83 |
| Mental Health Change at Week 104 (n=129,134) | 5.81 ± 1.59 | 5.27 ± 1.57 |
| Bodily Pain at Baseline (n=193,194) | 73.13 ± 2.21 | 75.61 ± 2.23 |
| Bodily Pain Change at Week 104 (n=131,134) | 3.23 ± 2.12 | -0.60 ± 2.10 |
| General Health at Baseline (n=191,194) | 60.50 ± 1.73 | 59.57 ± 1.73 |
| General Health Change at Week 104 (n=128,134) | 2.69 ± 1.80 | 5.32 ± 1.77 |
| Social Functioning at Baseline (n=193,194) | 64.02 ± 2.24 | 62.61 ± 2.25 |
| Social Functioning Change at Week 104 (n=131,134) | 8.13 ± 2.18 | 5.10 ± 2.16 |
| Vitality at Baseline (n=193,194) | 54.07 ± 1.81 | 49.67 ± 1.82 |
| Vitality Change at Week 104 (n=129,134) | 7.95 ± 1.67 | 9.01 ± 1.66 |
| Role-Emotional at Baseline (n=191,193) | 61.45 ± 3.60 | 55.34 ± 3.59 |
| Role-Emotional Change at Week 104 (n=129,134) | 16.38 ± 3.54 | 17.59 ± 3.49 |
Generic, multidimensional, health-related, quality-of-life instrument. Overall health status is self-reported using a visual analogue scale marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state. LS Mean values were adjusted for investigator and treatment at baseline; change values were also adjusted for baseline.
| Units on a Scale | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| Baseline (n=193,192) | 66.51 ± 4.58 | 72.18 ± 4.66 |
| Change from Baseline to Week 104 (n=128,130) | 0.07 ± 0.02 | 0.09 ± 0.02 |
Self-rated scale completed by patient's caregiver which measures level of burden placed on the caregiver by caring for the patient. Each of 19 items is rated on a scale from 0 (no impact) to 3 (high negative impact). Total Score range is 0-57. If any of the 19 questions were answered "not applicable", then a Total Score of 9 was entered. LS Mean values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline.
| Units on a Scale | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| Baseline (n=104,103) | 20.06 ± 1.29 | 20.90 ± 1.24 |
| Change from Baseline to Week 104 (n=68,64) | -5.02 ± 1.27 | -4.14 ± 1.29 |
Number of outpatient physician visits during the study, post-baseline through 104 weeks.
| Outpatient physician visits | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| Resource Utilization: Number of Outpatient Physician Visits During the Study | 0.32 ± 1.33 | 0.65 ± 1.57 |
Number of days of unpaid care, number of days of workdays missed, number of days of paid care per week during the study, post-baseline through 104 weeks.
| Days | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| Days of unpaid care per week (n=25,25) | 1.68 ± 3.05 | 1.40 ± 2.86 |
| Paid workdays missed per week (n=21,23) | 0.00 ± 0.00 | 0.00 ± 0.00 |
| Days of paid care per week (n=21,23) | 0.00 ± 0.00 | 0.00 ± 0.00 |
Mean - calculated based on total number of hospitalization days per patient within reporting interval.
| Days | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| Number of Hospitalization Days | 0.43 ± 1.99 | 1.80 ± 9.30 |
Interviewer-rated scale that assesses patients' awareness of and insight into their illness. SUMD can either be based on 4 items or 5 items. Items 1 through 4 are rated from 1 (aware) to 5 (unaware); item 5 assesses correct attribution of symptoms to a mental disorder and is rated from 1 (symptoms correctly attributed) to 5 (symptoms incorrectly attributed). Total Scores for Items (1-4) range from 4 to 20 and Total Scores for Items (1-5) range from 5 to 25. LS Mean values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline.
| Units on a Scale | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| Total Score (Items 1-5) Baseline | 11.12 ± 0.38 | 10.73 ± 0.39 |
| Total Score (Items 1-5) Change to Week 104 | -0.72 ± 0.35 | -0.50 ± 0.35 |
| Total Score (Items 1-4) Baseline | 8.81 ± 0.31 | 8.52 ± 0.32 |
| Total Score (Items 1-4) Change to Week 104 | -0.39 ± 0.27 | -0.29 ± 0.28 |
Self-rated scale assessing patients' level of alliance with their therapist, including agreement on goals, tasks, and emotional bond. Each of 12 items is rated from 1 ('never') to 7 ('always'), with higher scores indicating greater alliance. Total Scores range from 12-84. LS Mean values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline.
| Units on a Scale | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| Baseline | 63.83 ± 0.96 | 63.21 ± 1.02 |
| Change from Baseline to Week 104 | -0.92 ± 0.82 | -0.07 ± 0.88 |
Interviewer-rated 49-item scale used to assess 4 functional domains in patients with schizophrenia : 1) living situation, 2) instrumental activities of daily living, 3) productive activities and role functioning, and 4) social/recreational functioning. Possible responses and scoring vary by item and by domain, with higher scores representing better functioning. Range of possible scores is 1-100. LS Mean values were adjusted for investigator and treatment at baseline, and the change values were also adjusted for baseline.
| Units on a Scale | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| Baseline | 60.68 ± 1.39 | 60.47 ± 1.44 |
| Change from Baseline to Week 104 | 3.92 ± 1.27 | 3.26 ± 1.29 |
Self-rated scale which 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.
| Units on a Scale | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| Overall satisfaction with current medication | 4.20 ± 0.11 | 3.96 ± 0.11 |
| Preference current/previous medication (n=139,145) | 3.68 ± 0.10 | 3.83 ± 0.10 |
| Side effects - current vs previous medication | 1.91 ± 0.10 | 1.99 ± 0.10 |
Self-rated scale which measures patient's subjective feelings about taking medications. Each of 10 items is rated as true or false. For items 1, 3, 4, 6, 7, 9, and 10, true is scored as 1; false is scored as 0. For items 2, 5, and 8, true is scored as 0; false is scored as 1. Possible total scores range from 0-10. A subject who answers all 10 questions false will have a score of 3; a subject who answers all 10 questions true will have a score of 7. For 7 out of 10 questions, false is represented by 0, the other 3 questions false is represented by a value=1.
| Units on a Scale | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| Patient Attitude Toward Treatment Using the Drug Attitude Inventory (DAI) Scale Total Score at 104 Weeks | 7.44 ± 0.15 | 7.47 ± 0.15 |
Number of participants who discontinued study participation for any reason (excluding sponsor decision).
| Participants | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| Number of Participants With All-Cause Discontinuations (Excluding Sponsor Decision) | 142 | 133 |
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).
| Units on a Scale | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Scores at 104 Weeks | -0.36 ± 0.07 | -0.27 ± 0.07 |
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.
| Units on a Scale | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| PANSS Total Score | -0.82 ± 1.15 | -1.14 ± 1.15 |
| PANSS Positive Score | -0.48 ± 0.29 | -0.42 ± 0.29 |
| PANSS Negative Score | -0.20 ± 0.38 | -0.41 ± 0.38 |
| PANSS General Psychopathology Score | -0.51 ± 0.57 | -0.61 ± 0.56 |
Relapse is defined as any 1 of the following: 1) hospitalization for symptoms related to schizophrenia; 2) increase of 25% from baseline in PANSS total score (range:30-210) (if baseline score was \>40) or increase of 10 points (if baseline score was ≤40), and ≥1-point increase from baseline on CGI-S score (range:1-7), provided that increase results in CGI-S ≥4; 3) deliberate self-injury or injury to others deemed clinically to be associated with worsening of psychosis; 4) discontinuation from the study because of worsening of psychosis. On PANSS and CGI-S higher scores indicate greater illness.
| Days | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| Median Time to Relapse | 539.00 (105.00 to 736.00) | 623.50 (122.00 to 736.50) |
Relapse is defined as any one of the following: 1) hospitalization for symptoms related to schizophrenia; 2) an increase of 25% from baseline in the total score on the PANSS (if the baseline score was \>40), or an increase of 10 points (if baseline score was \<=40) and \>=1-point increase from baseline score on the CGI-S score, provided that the increase results in a CGI-S score \>=4; 3) deliberate self-injury or injury to others that is deemed clinically to be associated with worsening of psychosis; 4) discontinuation from the study because of worsening of psychosis.
| Participants | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| Number of Participants Experiencing Relapse | 53 | 48 |
BPRS is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. For this study, the BPRS total score was derived from 18 PANSS questions. To calculate the score, the score of the 18 questions was added then 18 was subtracted from the total. As an example, if a subject had a score=1 (absent) on all 18 items, the resulting total=zero. Responses range from 0 (absent) to 6 (extremely severe); the Total Score range is 0-108.
| Units on a scale | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score at 104 Weeks | -0.96 ± 0.60 | -0.91 ± 0.60 |
Number of outpatient surgeries during the study, post-baseline through 104 weeks.
| Surgeries | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| Resource Utilization: Number of Outpatient Surgeries During the Study, 24 Months After Randomization | 0.00 ± 0.00 | 0.04 ± 0.20 |
| Kilograms | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| Baseline | 81.56 ± 21.06 | 79.84 ± 19.04 |
| Change from Baseline to Week 104 | 2.04 ± 7.19 | 2.18 ± 7.33 |
PCS weight gain is defined as a \>=7% increase in weight from baseline at 104 weeks.
| Participants | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| Participants With Potentially Clinically Significant (PCS) Weight Gain at 104 Weeks | 106 | 97 |
Normal to high fasting glucose = \<100 milligrams per deciliter (mg/dL) baseline; \>=126 mg/dL any time post baseline (or endpoint). Normal to high fasting total cholesterol =\<200 mg/dL baseline; \>=240 mg/dL any time post baseline or endpoint. Fasting triglycerides \<150 mg/dL baseline; \>=200 mg/dL and \<500 mg/dL any time post baseline or endpoint.
| Participants | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| Fasting Glucose (n=243,241) | 25 | 17 |
| Fasting Total Cholesterol (n=242,231) | 12 | 14 |
| Fasting Triglycerides (n=242,231) | 48 | 44 |
The prolactin reference Range is: Female: 2.0 - 29.0 nanograms per milliliter (ng/mL); Male: 2.0 - 20.0 ng/mL. A treatment-emergent abnormally 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.
| Participants | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| Participants With Treatment-Emergent Abnormal High Prolactin at 104 Weeks | 12 | 12 |
Treatment-emergent (TE) high ALT is defined as a baseline value of \<3 times the upper limit of normal (ULN) to \>=3 times the ULN at endpoint. TE high AST is defined as a baseline value of \<5 times the ULN to \>=5 times the ULN at endpoint. TE high total bilirubin is defined as a baseline value of \<2 times the ULN to \>=2 times the ULN at endpoint. Hy's Rule is defined as ALT \>=3 times the ULN and total bilirubin \>=2 times the ULN.
| Participants | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| ALT (n=255,251) | 11 | 12 |
| AST (n=256,252) | 3 | 4 |
| Total bilirubin (n=256,253) | 0 | 2 |
| Hy's Rule (n=255,251) | 0 | 0 |
| Participants | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| Participants Discontinuing Because of an Adverse Event (AE) or Death | 26 | 27 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Olanzapine Pamoate Depot | — | 25/264 (9.5%) | 177/264 (67%) |
| Oral Olanzapine | — | 34/260 (13.1%) | 165/260 (63.5%) |
| Event | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| SchizophreniaPsychiatric disorders | 10/264 | 9/260 |
| Psychotic disorderPsychiatric disorders | 4/264 | 3/260 |
| PneumoniaInfections and infestations | 1/264 | 3/260 |
| Suicide attemptPsychiatric disorders | 1/264 | 3/260 |
| BronchitisInfections and infestations | 0/264 | 2/260 |
| AnxietyPsychiatric disorders | 2/264 | 0/260 |
| Suicidal ideationPsychiatric disorders | 2/264 | 1/260 |
| Atrial fibrillationCardiac disorders | 0/264 | 1/260 |
| Cardiac arrestCardiac disorders | 0/264 | 1/260 |
| Hepatitis acuteHepatobiliary disorders | 0/264 | 1/260 |
| Event | Olanzapine Pamoate Depot | Oral Olanzapine |
|---|---|---|
| Weight increasedInvestigations | 44/264 | 43/260 |
| InsomniaPsychiatric disorders | 29/264 | 26/260 |
| AnxietyPsychiatric disorders | 26/264 | 18/260 |
| SomnolenceNervous system disorders | 23/264 | 25/260 |
| HeadacheNervous system disorders | 12/264 | 22/260 |
| NasopharyngitisInfections and infestations | 18/264 | 14/260 |
| Increased appetiteMetabolism and nutrition disorders | 17/264 | 16/260 |
| Weight decreasedInvestigations | 15/264 | 14/260 |
| HypertensionVascular disorders | 9/264 | 13/260 |
| Age Continuous(years) | Olanzapine Pamoate Depot | Oral Olanzapine | Total |
|---|---|---|---|
| Mean | 41.70 ± 10.92 | 40.12 ± 10.84 | 40.92 ± 10.90 |
| Sex: Female, Male(Participants) | Olanzapine Pamoate Depot | Oral Olanzapine | Total |
|---|---|---|---|
| Female | 89 | 83 | 172 |
| Male | 175 | 177 | 352 |
| Race/Ethnicity, Customized(participants) | Olanzapine Pamoate Depot | Oral Olanzapine | Total |
|---|---|---|---|
| African | 41 | 47 | 88 |
| Caucasian | 161 | 164 | 325 |
| East Asian | 23 | 23 | 46 |
| Hispanic | 26 | 16 | 42 |
| Native American | 3 | 1 | 4 |
| West Asian (Indian sub-continent) | 10 | 9 | 19 |
| Unspecified | 0 | 0 | 0 |
| Region of Enrollment(participants) | Olanzapine Pamoate Depot | Oral Olanzapine | Total |
|---|---|---|---|
| Portugal | 9 | 11 | 20 |
| France | 13 | 14 | 27 |
| United States | 64 | 60 | 124 |
| Taiwan | 20 | 19 | 39 |
| Slovakia | 14 | 15 | 29 |
| Greece | 20 | 20 | 40 |
| Puerto Rico | 8 | 8 | 16 |
| Canada | 20 | 18 | 38 |
| Argentina | 32 | 30 | 62 |
| Brazil | 43 | 44 | 87 |
| Spain | 4 | 4 | 8 |
| Romania | 17 | 17 | 34 |
| Brief Psychiatric Rating Scale (BPRS) Total Score(Units on a scale) | Olanzapine Pamoate Depot | Oral Olanzapine | Total |
|---|---|---|---|
| Mean | 13.61 ± 5.82 | 13.11 ± 5.29 | 13.36 ± 5.56 |
| Length of Current Schizophrenic Episode(Days) | Olanzapine Pamoate Depot | Oral Olanzapine | Total |
|---|---|---|---|
| Mean | 179.16 ± 152.58 | 170.73 ± 143.34 | 174.98 ± 147.98 |
| Age of Onset of Illness(Years) | Olanzapine Pamoate Depot | Oral Olanzapine | Total |
|---|---|---|---|
| Mean | 25.95 ± 9.21 | 26.52 ± 8.65 | 26.24 ± 8.93 |
| Number of Schizophrenic Episodes or Exacerbations in the Previous 24 Months(Episodes) | Olanzapine Pamoate Depot | Oral Olanzapine | Total |
|---|---|---|---|
| Mean | 2.78 ± 1.81 | 2.67 ± 1.43 | 2.73 ± 1.63 |
2 further baseline measures are reported on the registry.
This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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