Trial Outcomes & Findings for Olanzapine Pamoate Depot Versus Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia (NCT NCT00320489)

NCT ID: NCT00320489

Last Updated: 2012-01-23

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

524 participants

Primary outcome timeframe

Baseline up to 104 weeks

Results posted on

2012-01-23

Participant Flow

Participant milestones

Participant milestones
Measure	Olanzapine Pamoate Depot 405 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.	Oral Olanzapine 10 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.
Overall Study STARTED	264	260
Overall Study COMPLETED	119	124
Overall Study NOT COMPLETED	145	136

Reasons for withdrawal

Reasons for withdrawal
Measure	Olanzapine Pamoate Depot 405 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.	Oral Olanzapine 10 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.
Overall Study Adverse Event	26	25
Overall Study Clinical Relapse	26	20
Overall Study Death	0	2
Overall Study Entry Criteria Exclusion	2	4
Overall Study Lack of Efficacy	16	7
Overall Study Lost to Follow-up	21	22
Overall Study Physician Decision	8	8
Overall Study Protocol Violation	4	4
Overall Study Sponsor Decision	3	3
Overall Study Withdrawal by Subject	39	41

Baseline Characteristics

Olanzapine Pamoate Depot Versus Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Olanzapine Pamoate Depot n=264 Participants 405 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.	Oral Olanzapine n=260 Participants 10 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.	Total n=524 Participants Total of all reporting groups
Age Continuous	41.70 years STANDARD_DEVIATION 10.92 • n=5 Participants	40.12 years STANDARD_DEVIATION 10.84 • n=7 Participants	40.92 years STANDARD_DEVIATION 10.90 • n=5 Participants
Sex: Female, Male Female	89 Participants n=5 Participants	83 Participants n=7 Participants	172 Participants n=5 Participants
Sex: Female, Male Male	175 Participants n=5 Participants	177 Participants n=7 Participants	352 Participants n=5 Participants
Race/Ethnicity, Customized African	41 participants n=5 Participants	47 participants n=7 Participants	88 participants n=5 Participants
Race/Ethnicity, Customized Caucasian	161 participants n=5 Participants	164 participants n=7 Participants	325 participants n=5 Participants
Race/Ethnicity, Customized East Asian	23 participants n=5 Participants	23 participants n=7 Participants	46 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	26 participants n=5 Participants	16 participants n=7 Participants	42 participants n=5 Participants
Race/Ethnicity, Customized Native American	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants
Race/Ethnicity, Customized West Asian (Indian sub-continent)	10 participants n=5 Participants	9 participants n=7 Participants	19 participants n=5 Participants
Race/Ethnicity, Customized Unspecified	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Region of Enrollment Portugal	9 participants n=5 Participants	11 participants n=7 Participants	20 participants n=5 Participants
Region of Enrollment France	13 participants n=5 Participants	14 participants n=7 Participants	27 participants n=5 Participants
Region of Enrollment United States	64 participants n=5 Participants	60 participants n=7 Participants	124 participants n=5 Participants
Region of Enrollment Taiwan	20 participants n=5 Participants	19 participants n=7 Participants	39 participants n=5 Participants
Region of Enrollment Slovakia	14 participants n=5 Participants	15 participants n=7 Participants	29 participants n=5 Participants
Region of Enrollment Greece	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants
Region of Enrollment Puerto Rico	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants
Region of Enrollment Canada	20 participants n=5 Participants	18 participants n=7 Participants	38 participants n=5 Participants
Region of Enrollment Argentina	32 participants n=5 Participants	30 participants n=7 Participants	62 participants n=5 Participants
Region of Enrollment Brazil	43 participants n=5 Participants	44 participants n=7 Participants	87 participants n=5 Participants
Region of Enrollment Spain	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment Romania	17 participants n=5 Participants	17 participants n=7 Participants	34 participants n=5 Participants
Brief Psychiatric Rating Scale (BPRS) Total Score	13.61 Units on a scale STANDARD_DEVIATION 5.82 • n=5 Participants	13.11 Units on a scale STANDARD_DEVIATION 5.29 • n=7 Participants	13.36 Units on a scale STANDARD_DEVIATION 5.56 • n=5 Participants
Length of Current Schizophrenic Episode	179.16 Days STANDARD_DEVIATION 152.58 • n=5 Participants	170.73 Days STANDARD_DEVIATION 143.34 • n=7 Participants	174.98 Days STANDARD_DEVIATION 147.98 • n=5 Participants
Age of Onset of Illness	25.95 Years STANDARD_DEVIATION 9.21 • n=5 Participants	26.52 Years STANDARD_DEVIATION 8.65 • n=7 Participants	26.24 Years STANDARD_DEVIATION 8.93 • n=5 Participants
Number of Schizophrenic Episodes or Exacerbations in the Previous 24 Months	2.78 Episodes STANDARD_DEVIATION 1.81 • n=5 Participants	2.67 Episodes STANDARD_DEVIATION 1.43 • n=7 Participants	2.73 Episodes STANDARD_DEVIATION 1.63 • n=5 Participants
Positivie and Negative Syndrome Scale (PANSS) Scores PANSS Total	56.78 Units on a scale STANDARD_DEVIATION 9.76 • n=5 Participants	56.50 Units on a scale STANDARD_DEVIATION 8.70 • n=7 Participants	56.64 Units on a scale STANDARD_DEVIATION 9.24 • n=5 Participants
Positivie and Negative Syndrome Scale (PANSS) Scores PANSS Positive	12.93 Units on a scale STANDARD_DEVIATION 3.62 • n=5 Participants	12.40 Units on a scale STANDARD_DEVIATION 3.33 • n=7 Participants	12.67 Units on a scale STANDARD_DEVIATION 3.49 • n=5 Participants
Positivie and Negative Syndrome Scale (PANSS) Scores PANSS Negative	15.84 Units on a scale STANDARD_DEVIATION 4.23 • n=5 Participants	16.28 Units on a scale STANDARD_DEVIATION 3.93 • n=7 Participants	16.06 Units on a scale STANDARD_DEVIATION 4.08 • n=5 Participants
Positivie and Negative Syndrome Scale (PANSS) Scores PANSS General Pathology	28.00 Units on a scale STANDARD_DEVIATION 5.45 • n=5 Participants	27.81 Units on a scale STANDARD_DEVIATION 4.92 • n=7 Participants	27.91 Units on a scale STANDARD_DEVIATION 5.19 • n=5 Participants
Clinical Global Impressions of Severity (CGI-S)	3.24 Units on a scale STANDARD_DEVIATION 0.77 • n=5 Participants	3.26 Units on a scale STANDARD_DEVIATION 0.66 • n=7 Participants	3.25 Units on a scale STANDARD_DEVIATION 0.72 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 104 weeks

Population: All data was analyzed on an intent-to-treat (ITT) basis. An ITT analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.

Outcome measures

Outcome measures
Measure	Olanzapine Pamoate Depot n=264 Participants 405 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.	Oral Olanzapine n=260 Participants 10 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.
Median Time to Discontinuation for Any Reason (Excluding Sponsor Decision)	644.50 Days Interval 162.0 to 740.0	677.50 Days Interval 169.5 to 740.0

SECONDARY outcome

Timeframe: Baseline, 104 weeks

Population: All data were analyzed on ITT basis. ITT analysis: analysis of all randomized patients allocated to the randomized treatment even if they did not take assigned treatment, did not receive correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on mixed-model repeated measures (MMRM) methodology.

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.

Outcome measures

Outcome measures
Measure	Olanzapine Pamoate Depot n=130 Participants 405 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.	Oral Olanzapine n=135 Participants 10 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.
Change From Baseline in Heinrich-Carpenter Quality of Life in Schizophrenia Scale (QLS) Total Score at 104 Weeks Baseline (n=193,193)	60.09 Units on a Scale Standard Error 1.79	57.73 Units on a Scale Standard Error 1.80
Change From Baseline in Heinrich-Carpenter Quality of Life in Schizophrenia Scale (QLS) Total Score at 104 Weeks Change from Baseline at Week 104 (n=130,135)	8.15 Units on a Scale Standard Error 1.57	7.24 Units on a Scale Standard Error 1.56

SECONDARY outcome

Timeframe: Baseline, 104 weeks

Population: All data analyzed on ITT basis. ITT analysis: analysis of all randomized patients with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.

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.

Outcome measures

Outcome measures
Measure	Olanzapine Pamoate Depot n=131 Participants 405 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.	Oral Olanzapine n=134 Participants 10 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.
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores Role-Physical at Baseline (n=192,194)	63.60 Units on a Scale Standard Error 3.42	60.74 Units on a Scale Standard Error 3.43
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores Mental Score Detail at Baseline (n=188,193)	42.12 Units on a Scale Standard Error 1.02	40.56 Units on a Scale Standard Error 1.01
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores Mental Score Detail Change at Week 104 (n=124,134)	4.87 Units on a Scale Standard Error 0.89	4.52 Units on a Scale Standard Error 0.87
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores Physical Score Detail at Baseline (n=188,193)	47.80 Units on a Scale Standard Error 0.73	47.91 Units on a Scale Standard Error 0.72
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores Physical Score Detail Change Week 104 (n=124,134)	0.43 Units on a Scale Standard Error 0.75	0.84 Units on a Scale Standard Error 0.73
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores Physical Functioning at Baseline (n=193,194)	76.18 Units on a Scale Standard Error 2.02	75.63 Units on a Scale Standard Error 2.03
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores Physical Functioning Change Week 104 (n=129,134)	1.35 Units on a Scale Standard Error 1.89	2.44 Units on a Scale Standard Error 1.87
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores Role-Physical Change at Week 104 (n=130,134)	10.70 Units on a Scale Standard Error 3.42	13.76 Units on a Scale Standard Error 3.38
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores Mental Health at Baseline (n=192,194)	61.18 Units on a Scale Standard Error 1.84	60.10 Units on a Scale Standard Error 1.83
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores Mental Health Change at Week 104 (n=129,134)	5.81 Units on a Scale Standard Error 1.59	5.27 Units on a Scale Standard Error 1.57
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores Bodily Pain at Baseline (n=193,194)	73.13 Units on a Scale Standard Error 2.21	75.61 Units on a Scale Standard Error 2.23
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores Bodily Pain Change at Week 104 (n=131,134)	3.23 Units on a Scale Standard Error 2.12	-0.60 Units on a Scale Standard Error 2.10
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores General Health at Baseline (n=191,194)	60.50 Units on a Scale Standard Error 1.73	59.57 Units on a Scale Standard Error 1.73
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores General Health Change at Week 104 (n=128,134)	2.69 Units on a Scale Standard Error 1.80	5.32 Units on a Scale Standard Error 1.77
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores Social Functioning at Baseline (n=193,194)	64.02 Units on a Scale Standard Error 2.24	62.61 Units on a Scale Standard Error 2.25
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores Social Functioning Change at Week 104 (n=131,134)	8.13 Units on a Scale Standard Error 2.18	5.10 Units on a Scale Standard Error 2.16
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores Vitality at Baseline (n=193,194)	54.07 Units on a Scale Standard Error 1.81	49.67 Units on a Scale Standard Error 1.82
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores Vitality Change at Week 104 (n=129,134)	7.95 Units on a Scale Standard Error 1.67	9.01 Units on a Scale Standard Error 1.66
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores Role-Emotional at Baseline (n=191,193)	61.45 Units on a Scale Standard Error 3.60	55.34 Units on a Scale Standard Error 3.59
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores Role-Emotional Change at Week 104 (n=129,134)	16.38 Units on a Scale Standard Error 3.54	17.59 Units on a Scale Standard Error 3.49

SECONDARY outcome

Timeframe: Baseline, 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.

Outcome measures

Outcome measures
Measure	Olanzapine Pamoate Depot n=128 Participants 405 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.	Oral Olanzapine n=130 Participants 10 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.
Change From Baseline in Overall Health Status Assessment Using the EuroQol: 5 Dimensions Questionnaire (EQ-5D) at 104 Weeks Baseline (n=193,192)	66.51 Units on a Scale Standard Error 4.58	72.18 Units on a Scale Standard Error 4.66
Change From Baseline in Overall Health Status Assessment Using the EuroQol: 5 Dimensions Questionnaire (EQ-5D) at 104 Weeks Change from Baseline to Week 104 (n=128,130)	0.07 Units on a Scale Standard Error 0.02	0.09 Units on a Scale Standard Error 0.02

SECONDARY outcome

Timeframe: Baseline, 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.

Outcome measures

Outcome measures
Measure	Olanzapine Pamoate Depot n=68 Participants 405 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.	Oral Olanzapine n=64 Participants 10 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.
Change From Baseline in Burden Assessment Scale (BAS) Total Score at 104 Weeks Baseline (n=104,103)	20.06 Units on a Scale Standard Error 1.29	20.90 Units on a Scale Standard Error 1.24
Change From Baseline in Burden Assessment Scale (BAS) Total Score at 104 Weeks Change from Baseline to Week 104 (n=68,64)	-5.02 Units on a Scale Standard Error 1.27	-4.14 Units on a Scale Standard Error 1.29

SECONDARY outcome

Timeframe: Baseline through 104 weeks

Population: All data was analyzed on an intent-to-treat basis. An intent-to-treat analysis is an analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if a patient does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.

Number of outpatient physician visits during the study, post-baseline through 104 weeks.

Outcome measures

Outcome measures
Measure	Olanzapine Pamoate Depot n=28 Participants 405 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.	Oral Olanzapine n=26 Participants 10 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.
Resource Utilization: Number of Outpatient Physician Visits During the Study	0.32 Outpatient physician visits Standard Deviation 1.33	0.65 Outpatient physician visits Standard Deviation 1.57

SECONDARY outcome

Timeframe: Baseline through 104 weeks

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.

Outcome measures

Outcome measures
Measure	Olanzapine Pamoate Depot n=25 Participants 405 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.	Oral Olanzapine n=25 Participants 10 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.
Resource Utilization: Days of Unpaid Care, Days of Workdays Missed, Days of Paid Care Per Week During the Study Days of unpaid care per week (n=25,25)	1.68 Days Standard Deviation 3.05	1.40 Days Standard Deviation 2.86
Resource Utilization: Days of Unpaid Care, Days of Workdays Missed, Days of Paid Care Per Week During the Study Paid workdays missed per week (n=21,23)	0.00 Days Standard Deviation 0.00	0.00 Days Standard Deviation 0.00
Resource Utilization: Days of Unpaid Care, Days of Workdays Missed, Days of Paid Care Per Week During the Study Days of paid care per week (n=21,23)	0.00 Days Standard Deviation 0.00	0.00 Days Standard Deviation 0.00

SECONDARY outcome

Timeframe: Baseline through 104 weeks

Mean - calculated based on total number of hospitalization days per patient within reporting interval.

Outcome measures

Outcome measures
Measure	Olanzapine Pamoate Depot n=264 Participants 405 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.	Oral Olanzapine n=260 Participants 10 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.
Number of Hospitalization Days	0.43 Days Standard Deviation 1.99	1.80 Days Standard Deviation 9.30

SECONDARY outcome

Timeframe: Baseline, 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.

Outcome measures

Outcome measures
Measure	Olanzapine Pamoate Depot n=211 Participants 405 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.	Oral Olanzapine n=200 Participants 10 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.
Change From Baseline in Scale to Assess Unawareness of Mental Disorder (SUMD) Total Score at 104 Weeks Total Score (Items 1-5) Baseline	11.12 Units on a Scale Standard Error 0.38	10.73 Units on a Scale Standard Error 0.39
Change From Baseline in Scale to Assess Unawareness of Mental Disorder (SUMD) Total Score at 104 Weeks Total Score (Items 1-5) Change to Week 104	-0.72 Units on a Scale Standard Error 0.35	-0.50 Units on a Scale Standard Error 0.35
Change From Baseline in Scale to Assess Unawareness of Mental Disorder (SUMD) Total Score at 104 Weeks Total Score (Items 1-4) Baseline	8.81 Units on a Scale Standard Error 0.31	8.52 Units on a Scale Standard Error 0.32
Change From Baseline in Scale to Assess Unawareness of Mental Disorder (SUMD) Total Score at 104 Weeks Total Score (Items 1-4) Change to Week 104	-0.39 Units on a Scale Standard Error 0.27	-0.29 Units on a Scale Standard Error 0.28

SECONDARY outcome

Timeframe: Baseline, 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.

Outcome measures

Outcome measures
Measure	Olanzapine Pamoate Depot n=195 Participants 405 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.	Oral Olanzapine n=184 Participants 10 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.
Change From Baseline in Working Alliance Inventory (WAI) Total Score at 104 Weeks Baseline	63.83 Units on a Scale Standard Error 0.96	63.21 Units on a Scale Standard Error 1.02
Change From Baseline in Working Alliance Inventory (WAI) Total Score at 104 Weeks Change from Baseline to Week 104	-0.92 Units on a Scale Standard Error 0.82	-0.07 Units on a Scale Standard Error 0.88

SECONDARY outcome

Timeframe: Baseline, 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.

Outcome measures

Outcome measures
Measure	Olanzapine Pamoate Depot n=120 Participants 405 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.	Oral Olanzapine n=124 Participants 10 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.
Change From Baseline in Schizophrenia Objective Functioning Instrument (SOFI) Global Score at 104 Weeks Baseline	60.68 Units on a Scale Standard Error 1.39	60.47 Units on a Scale Standard Error 1.44
Change From Baseline in Schizophrenia Objective Functioning Instrument (SOFI) Global Score at 104 Weeks Change from Baseline to Week 104	3.92 Units on a Scale Standard Error 1.27	3.26 Units on a Scale Standard Error 1.29

SECONDARY outcome

Timeframe: 104 weeks

Population: All data analyzed on an ITT basis. ITT analysis: analysis of all randomized patients, with patients allocated to the treatment to which they were randomized even if they did not take assigned treatment, did not receive correct treatment, or otherwise did not follow the protocol. Assessment of baseline-to-endpoint change based on MMRM methodology.

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.

Outcome measures

Outcome measures
Measure	Olanzapine Pamoate Depot n=139 Participants 405 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.	Oral Olanzapine n=146 Participants 10 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.
Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at 104 Weeks (All Items) Preference current/previous medication (n=139,145)	3.68 Units on a Scale Standard Error 0.10	3.83 Units on a Scale Standard Error 0.10
Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at 104 Weeks (All Items) Overall satisfaction with current medication	4.20 Units on a Scale Standard Error 0.11	3.96 Units on a Scale Standard Error 0.11
Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at 104 Weeks (All Items) Side effects - current vs previous medication	1.91 Units on a Scale Standard Error 0.10	1.99 Units on a Scale Standard Error 0.10

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Olanzapine Pamoate Depot n=137 Participants 405 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.	Oral Olanzapine n=143 Participants 10 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.
Patient Attitude Toward Treatment Using the Drug Attitude Inventory (DAI) Scale Total Score at 104 Weeks	7.44 Units on a Scale Standard Error 0.15	7.47 Units on a Scale Standard Error 0.15

SECONDARY outcome

Timeframe: Baseline through 104 weeks

Number of participants who discontinued study participation for any reason (excluding sponsor decision).

Outcome measures

Outcome measures
Measure	Olanzapine Pamoate Depot n=264 Participants 405 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.	Oral Olanzapine n=260 Participants 10 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.
Number of Participants With All-Cause Discontinuations (Excluding Sponsor Decision)	142 Participants	133 Participants

SECONDARY outcome

Timeframe: Baseline, 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).

Outcome measures

Outcome measures
Measure	Olanzapine Pamoate Depot n=121 Participants 405 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.	Oral Olanzapine n=128 Participants 10 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.
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Scores at 104 Weeks	-0.36 Units on a Scale Standard Error 0.07	-0.27 Units on a Scale Standard Error 0.07

SECONDARY outcome

Timeframe: Baseline, 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.

Outcome measures

Outcome measures
Measure	Olanzapine Pamoate Depot n=121 Participants 405 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.	Oral Olanzapine n=128 Participants 10 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.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total and Subscale Scores at 104 Weeks PANSS Total Score	-0.82 Units on a Scale Standard Error 1.15	-1.14 Units on a Scale Standard Error 1.15
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total and Subscale Scores at 104 Weeks PANSS Positive Score	-0.48 Units on a Scale Standard Error 0.29	-0.42 Units on a Scale Standard Error 0.29
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total and Subscale Scores at 104 Weeks PANSS Negative Score	-0.20 Units on a Scale Standard Error 0.38	-0.41 Units on a Scale Standard Error 0.38
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total and Subscale Scores at 104 Weeks PANSS General Psychopathology Score	-0.51 Units on a Scale Standard Error 0.57	-0.61 Units on a Scale Standard Error 0.56

SECONDARY outcome

Timeframe: Baseline to time of relapse (up to 104 weeks)

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.

Outcome measures

Outcome measures
Measure	Olanzapine Pamoate Depot n=264 Participants 405 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.	Oral Olanzapine n=260 Participants 10 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.
Median Time to Relapse	539.00 Days Interval 105.0 to 736.0	623.50 Days Interval 122.0 to 736.5

SECONDARY outcome

Timeframe: Baseline through 104 weeks

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.

Outcome measures

Outcome measures
Measure	Olanzapine Pamoate Depot n=264 Participants 405 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.	Oral Olanzapine n=260 Participants 10 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.
Number of Participants Experiencing Relapse	53 Participants	48 Participants

SECONDARY outcome

Timeframe: Baseline, 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.

Outcome measures

Outcome measures
Measure	Olanzapine Pamoate Depot n=121 Participants 405 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.	Oral Olanzapine n=128 Participants 10 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.
Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score at 104 Weeks	-0.96 Units on a scale Standard Error 0.60	-0.91 Units on a scale Standard Error 0.60

SECONDARY outcome

Timeframe: Baseline through 104 Weeks

Number of outpatient surgeries during the study, post-baseline through 104 weeks.

Outcome measures

Outcome measures
Measure	Olanzapine Pamoate Depot n=28 Participants 405 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.	Oral Olanzapine n=26 Participants 10 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.
Resource Utilization: Number of Outpatient Surgeries During the Study, 24 Months After Randomization	0.00 Surgeries Standard Deviation 0.00	0.04 Surgeries Standard Deviation 0.20

SECONDARY outcome

Timeframe: Baseline, 104 weeks

Outcome measures

Outcome measures
Measure	Olanzapine Pamoate Depot n=260 Participants 405 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.	Oral Olanzapine n=255 Participants 10 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.
Change From Baseline in Weight at 104 Weeks Baseline	81.56 Kilograms Standard Deviation 21.06	79.84 Kilograms Standard Deviation 19.04
Change From Baseline in Weight at 104 Weeks Change from Baseline to Week 104	2.04 Kilograms Standard Deviation 7.19	2.18 Kilograms Standard Deviation 7.33

SECONDARY outcome

Timeframe: Baseline, 104 weeks

PCS weight gain is defined as a \>=7% increase in weight from baseline at 104 weeks.

Outcome measures

Outcome measures
Measure	Olanzapine Pamoate Depot n=260 Participants 405 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.	Oral Olanzapine n=255 Participants 10 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.
Participants With Potentially Clinically Significant (PCS) Weight Gain at 104 Weeks	106 Participants	97 Participants

SECONDARY outcome

Timeframe: Baseline through 104 weeks

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.

Outcome measures

Outcome measures
Measure	Olanzapine Pamoate Depot n=243 Participants 405 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.	Oral Olanzapine n=241 Participants 10 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.
Participants With Normal to High Fasting Glucose, Fasting Total Cholesterol, and Fasting Triglycerides Fasting Total Cholesterol (n=242,231)	12 Participants	14 Participants
Participants With Normal to High Fasting Glucose, Fasting Total Cholesterol, and Fasting Triglycerides Fasting Triglycerides (n=242,231)	48 Participants	44 Participants
Participants With Normal to High Fasting Glucose, Fasting Total Cholesterol, and Fasting Triglycerides Fasting Glucose (n=243,241)	25 Participants	17 Participants

SECONDARY outcome

Timeframe: Baseline, 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.

Outcome measures

Outcome measures
Measure	Olanzapine Pamoate Depot n=226 Participants 405 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.	Oral Olanzapine n=217 Participants 10 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.
Participants With Treatment-Emergent Abnormal High Prolactin at 104 Weeks	12 Participants	12 Participants

SECONDARY outcome

Timeframe: Baseline through 104 Weeks

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.

Outcome measures

Outcome measures
Measure	Olanzapine Pamoate Depot n=256 Participants 405 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.	Oral Olanzapine n=253 Participants 10 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.
Participants With Treatment-Emergent High Alanine Transaminase (ALT), Aspartate Transaminase (AST), and Total Bilirubin Hy's Rule (n=255,251)	0 Participants	0 Participants
Participants With Treatment-Emergent High Alanine Transaminase (ALT), Aspartate Transaminase (AST), and Total Bilirubin ALT (n=255,251)	11 Participants	12 Participants
Participants With Treatment-Emergent High Alanine Transaminase (ALT), Aspartate Transaminase (AST), and Total Bilirubin AST (n=256,252)	3 Participants	4 Participants
Participants With Treatment-Emergent High Alanine Transaminase (ALT), Aspartate Transaminase (AST), and Total Bilirubin Total bilirubin (n=256,253)	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline through 104 weeks

Outcome measures

Outcome measures
Measure	Olanzapine Pamoate Depot n=264 Participants 405 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.	Oral Olanzapine n=260 Participants 10 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.
Participants Discontinuing Because of an Adverse Event (AE) or Death	26 Participants	27 Participants

Adverse Events

Olanzapine Pamoate Depot

Serious events: 25 serious events

Other events: 177 other events

Deaths: 0 deaths

Oral Olanzapine

Serious events: 34 serious events

Other events: 165 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Olanzapine Pamoate Depot n=264 participants at risk 405 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.	Oral Olanzapine n=260 participants at risk 10 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.
Cardiac disorders Angina unstable	0.38% 1/264 • Number of events 1	0.00% 0/260
Cardiac disorders Atrial fibrillation	0.00% 0/264	0.38% 1/260 • Number of events 1
Cardiac disorders Cardiac arrest	0.00% 0/264	0.38% 1/260 • Number of events 1
Hepatobiliary disorders Cholelithiasis	0.38% 1/264 • Number of events 1	0.00% 0/260
Hepatobiliary disorders Hepatitis acute	0.00% 0/264	0.38% 1/260 • Number of events 1
Infections and infestations Bronchitis	0.00% 0/264	0.77% 2/260 • Number of events 2
Infections and infestations Pneumonia	0.38% 1/264 • Number of events 1	1.2% 3/260 • Number of events 3
Infections and infestations Sepsis	0.00% 0/264	0.38% 1/260 • Number of events 1
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/264	0.38% 1/260 • Number of events 1
Injury, poisoning and procedural complications Femur fracture	0.00% 0/264	0.38% 1/260 • Number of events 1
Injury, poisoning and procedural complications Fracture	0.38% 1/264 • Number of events 1	0.00% 0/260
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/264	0.38% 1/260 • Number of events 1
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/264	0.38% 1/260 • Number of events 1
Metabolism and nutrition disorders Hyperglycaemia	0.38% 1/264 • Number of events 1	0.00% 0/260
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/264	0.38% 1/260 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ependymoma	0.00% 0/264	0.38% 1/260 • Number of events 1
Nervous system disorders Cerebrovascular accident	0.00% 0/264	0.38% 1/260 • Number of events 1
Nervous system disorders Convulsion	0.00% 0/264	0.38% 1/260 • Number of events 1
Nervous system disorders Metabolic encephalopathy	0.00% 0/264	0.38% 1/260 • Number of events 1
Psychiatric disorders Acute psychosis	0.00% 0/264	0.38% 1/260 • Number of events 1
Psychiatric disorders Aggression	0.00% 0/264	0.38% 1/260 • Number of events 1
Psychiatric disorders Agitation	0.00% 0/264	0.38% 1/260 • Number of events 1
Psychiatric disorders Alcohol abuse	0.00% 0/264	0.38% 1/260 • Number of events 1
Psychiatric disorders Anxiety	0.76% 2/264 • Number of events 2	0.00% 0/260
Psychiatric disorders Confusional state	0.00% 0/264	0.38% 1/260 • Number of events 1
Psychiatric disorders Depressive symptom	0.38% 1/264 • Number of events 1	0.00% 0/260
Psychiatric disorders Hallucination, auditory	0.00% 0/264	0.38% 1/260 • Number of events 1
Psychiatric disorders Homicidal ideation	0.00% 0/264	0.38% 1/260 • Number of events 1
Psychiatric disorders Impulsive behaviour	0.00% 0/264	0.38% 1/260 • Number of events 1
Psychiatric disorders Paranoia	0.00% 0/264	0.38% 1/260 • Number of events 1
Psychiatric disorders Psychotic disorder	1.5% 4/264 • Number of events 4	1.2% 3/260 • Number of events 3
Psychiatric disorders Schizophrenia	3.8% 10/264 • Number of events 10	3.5% 9/260 • Number of events 9
Psychiatric disorders Suicidal ideation	0.76% 2/264 • Number of events 2	0.38% 1/260 • Number of events 1
Psychiatric disorders Suicide attempt	0.38% 1/264 • Number of events 1	1.2% 3/260 • Number of events 3
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/264	0.38% 1/260 • Number of events 1
Respiratory, thoracic and mediastinal disorders Lung disorder	0.38% 1/264 • Number of events 1	0.00% 0/260
Skin and subcutaneous tissue disorders Hypoaesthesia facial	0.38% 1/264 • Number of events 1	0.00% 0/260
Vascular disorders Arterial thrombosis limb	0.00% 0/264	0.38% 1/260 • Number of events 1
Vascular disorders Deep vein thrombosis	0.38% 1/264 • Number of events 1	0.00% 0/260
Vascular disorders Hypovolaemic shock	0.00% 0/264	0.38% 1/260 • Number of events 1

Other adverse events

Other adverse events
Measure	Olanzapine Pamoate Depot n=264 participants at risk 405 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.	Oral Olanzapine n=260 participants at risk 10 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.
Infections and infestations Nasopharyngitis	6.8% 18/264 • Number of events 23	5.4% 14/260 • Number of events 24
Investigations Weight decreased	5.7% 15/264 • Number of events 18	5.4% 14/260 • Number of events 15
Investigations Weight increased	16.7% 44/264 • Number of events 51	16.5% 43/260 • Number of events 47
Metabolism and nutrition disorders Increased appetite	6.4% 17/264 • Number of events 17	6.2% 16/260 • Number of events 16
Nervous system disorders Headache	4.5% 12/264 • Number of events 25	8.5% 22/260 • Number of events 36
Nervous system disorders Somnolence	8.7% 23/264 • Number of events 24	9.6% 25/260 • Number of events 28
Psychiatric disorders Anxiety	9.8% 26/264 • Number of events 37	6.9% 18/260 • Number of events 21
Psychiatric disorders Insomnia	11.0% 29/264 • Number of events 37	10.0% 26/260 • Number of events 33
Vascular disorders Hypertension	3.4% 9/264 • Number of events 11	5.0% 13/260 • Number of events 13

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60