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

January 19, 2012 updated by: Eli Lilly and Company

A Randomized, Open-label Study Comparing the Effects of Olanzapine Pamoate Depot With Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia

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.

Study Overview

Status

Completed

Conditions

Schizophrenia

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

524

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Banfield, Argentina, B1828CKR
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Buenos Aires, Argentina, 1118
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  - Mendoza, Argentina, M5500GAC
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Brazil
- - Pelotas, Brazil, 96030-000
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  - Rio De Janeiro, Brazil, 21020-130
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  - São Paulo, Brazil, 04044-000
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Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 2T9
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Manitoba
  - Winnipeg, Manitoba, Canada, R3E 3N4
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Ontario
  - Burlington, Ontario, Canada, L7N 3V2
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Chatham, Ontario, Canada, N7L 1B7
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  - Sudbury, Ontario, Canada, P3E 1X3
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Quebec
  - Montreal, Quebec, Canada, H3A 1A1
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
France
- - Dijon, France, 21033
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  - Dole, France, 39100
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - La Seyne Sur Mer, France, 83500
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  - Limoges, France, 87025
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Strasbourg, France, 67000
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Toulon, France, 83506
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Greece
- - Chaidari, Greece, 12461
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  - Haidari, Athens, Greece, 12462
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  - Thessaloniki, Greece, 54630
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Tripoli, Greece, 22100
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Portugal
- - Lisbon, Portugal, 1169053
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Puerto Rico
- - Cabo Rojo, Puerto Rico, 00623
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Caguas, Puerto Rico, 00725
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  - Mayaguez, Puerto Rico, 00680
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Rio Piedras, Puerto Rico, 00926
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Romania
- - Bucharest, Romania, 73120
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Iasi, Romania, 700282
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Targu Mures, Romania, 540139
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Slovakia
- - Bratislava, Slovakia, 826 06
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Spain
- - Alcira, Spain, 46600
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Barcelona, Spain, 08003
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Taiwan
- - Hua-Lian County, Taiwan, 981
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Taipei, Taiwan, 114
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  - Taoyuan City, Taiwan, 330
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
United States
- California
  - Escondido, California, United States, 92025
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - National City, California, United States, 91950
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Orange, California, United States, 92868
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - San Diego, California, United States, 92123
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- District of Columbia
  - Washington, District of Columbia, United States, 20016
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Hawaii
  - Honolulu, Hawaii, United States, 96826
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Illinois
  - Chicago, Illinois, United States, 60640
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- New York
  - Cedarhurst, New York, United States, 11516
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Staten Island, New York, United States, 10305
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Ohio
  - Canton, Ohio, United States, 44708
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18104
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - Philadelphia, Pennsylvania, United States, 19139
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  - West Chester, Pennsylvania, United States, 19380
    - For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Clinical diagnosis of schizophrenia
Must be an outpatient (not requiring hospitalization) now and for at least the past 8 weeks.
Disease symptoms must meet a certain range as assessed by the clinician.
Patient has experienced at least two episodes of clinical worsening of their condition. This could mean admission to a hospital or an emergency room visit. This could mean that a new medication was added, medication dose was increased, or medication was switched in order to better control symptoms of the condition.
The patient must have an unsatisfactory response to their current medication or be experiencing negative effects of their current medication or not always take their current medication so that a change in current medication is desired.

Exclusion Criteria:

Patients who are actively suicidal.
Patients who are pregnant or nursing.
Patients who have stopped past treatment with olanzapine because of adverse events, are treatment resistant or allergic to olanzapine, or have a condition which would prevent use of a long acting form of olanzapine.
Patients with uncorrected narrow-angle glaucoma, seizures, uncontrolled diabetes, certain diseases of the liver, uncontrolled thyroid condition or other serious or unstable illness.
Patients with Parkinson's disease, psychosis related to dementia or other related disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Olanzapine Pamoate Depot Olanzapine pamoate depot	Drug: olanzapine pamoate depot 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.
Active Comparator: Olanzapine 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. Other Names: Zyprexa LY170053

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Median Time to Discontinuation for Any Reason (Excluding Sponsor Decision) Time Frame: Baseline up to 104 weeks	Baseline up to 104 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Heinrich-Carpenter Quality of Life in Schizophrenia Scale (QLS) Total Score at 104 Weeks Time Frame: Baseline, 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.	Baseline, 104 weeks
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores Time Frame: Baseline, 104 weeks	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.	Baseline, 104 weeks
Change From Baseline in Overall Health Status Assessment Using the EuroQol: 5 Dimensions Questionnaire (EQ-5D) at 104 Weeks Time Frame: 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.	Baseline, 104 weeks
Change From Baseline in Burden Assessment Scale (BAS) Total Score at 104 Weeks Time Frame: 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.	Baseline, 104 weeks
Resource Utilization: Number of Outpatient Physician Visits During the Study Time Frame: Baseline through 104 weeks	Number of outpatient physician visits during the study, post-baseline through 104 weeks.	Baseline through 104 weeks
Resource Utilization: Days of Unpaid Care, Days of Workdays Missed, Days of Paid Care Per Week During the Study Time Frame: 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.	Baseline through 104 weeks
Number of Hospitalization Days Time Frame: Baseline through 104 weeks	Mean - calculated based on total number of hospitalization days per patient within reporting interval.	Baseline through 104 weeks
Change From Baseline in Scale to Assess Unawareness of Mental Disorder (SUMD) Total Score at 104 Weeks Time Frame: 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.	Baseline, 104 weeks
Change From Baseline in Working Alliance Inventory (WAI) Total Score at 104 Weeks Time Frame: 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.	Baseline, 104 weeks
Change From Baseline in Schizophrenia Objective Functioning Instrument (SOFI) Global Score at 104 Weeks Time Frame: 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.	Baseline, 104 weeks
Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at 104 Weeks (All Items) Time Frame: 104 weeks	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.	104 weeks
Patient Attitude Toward Treatment Using the Drug Attitude Inventory (DAI) Scale Total Score at 104 Weeks Time Frame: 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.	104 weeks
Number of Participants With All-Cause Discontinuations (Excluding Sponsor Decision) Time Frame: Baseline through 104 weeks	Number of participants who discontinued study participation for any reason (excluding sponsor decision).	Baseline through 104 weeks
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Scores at 104 Weeks Time Frame: 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).	Baseline, 104 weeks
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total and Subscale Scores at 104 Weeks Time Frame: 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.	Baseline, 104 weeks
Median Time to Relapse Time Frame: 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.	Baseline to time of relapse (up to 104 weeks)
Number of Participants Experiencing Relapse Time Frame: 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.	Baseline through 104 weeks
Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score at 104 Weeks Time Frame: 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.	Baseline, 104 weeks
Resource Utilization: Number of Outpatient Surgeries During the Study, 24 Months After Randomization Time Frame: Baseline through 104 Weeks	Number of outpatient surgeries during the study, post-baseline through 104 weeks.	Baseline through 104 Weeks
Change From Baseline in Weight at 104 Weeks Time Frame: Baseline, 104 weeks		Baseline, 104 weeks
Participants With Potentially Clinically Significant (PCS) Weight Gain at 104 Weeks Time Frame: Baseline, 104 weeks	PCS weight gain is defined as a >=7% increase in weight from baseline at 104 weeks.	Baseline, 104 weeks
Participants With Normal to High Fasting Glucose, Fasting Total Cholesterol, and Fasting Triglycerides Time Frame: 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.	Baseline through 104 weeks
Participants With Treatment-Emergent Abnormal High Prolactin at 104 Weeks Time Frame: 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.	Baseline, 104 weeks
Participants With Treatment-Emergent High Alanine Transaminase (ALT), Aspartate Transaminase (AST), and Total Bilirubin Time Frame: 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.	Baseline through 104 Weeks
Participants Discontinuing Because of an Adverse Event (AE) or Death Time Frame: Baseline through 104 weeks		Baseline through 104 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT- 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Lilly Clinical Trial Registry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

April 28, 2006

First Submitted That Met QC Criteria

May 2, 2006

First Posted (Estimate)

May 3, 2006

Study Record Updates

Last Update Posted (Estimate)

January 23, 2012

Last Update Submitted That Met QC Criteria

January 19, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

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Other Study ID Numbers

6390
F1D-MC-HGLQ (Other Identifier: Eli Lilly and Company)

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Clinical Trials on Schizophrenia

Organon and Co

Completed

Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897)

Schizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
Organon and Co

Completed

Fixed Dose Efficacy and Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05896)

Schizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
All India Institute of Medical Sciences, Bhubaneswar

Recruiting

Dextromethorphan as an Augmentation Agent in Treatment-resistant Schizophrenia

Treatment Resistant Schizophrenia

India
Bradley Lega

Recruiting

Deep Brain Stimulation for Psychosis

Treatment-Refractory Schizophrenia

United States
King's College London
South London and Maudsley NHS Foundation Trust

Recruiting

The Role of Glutamatergic Function in the Pathophysiology of Treatment-resistant Schizophrenia (RESTORE)

Treatment-resistant Schizophrenia | Healthy Controls | Treatment-responsive Schizophrenia

United Kingdom
University of Sao Paulo

Unknown

Electroconvulsive Therapy (ECT) in Patients With Super Refractory Schizophrenia (SSURECT)

Refractory Schizophrenia | Super Refractory Schizophrenia

Brazil
Ohio State University

Recruiting

An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine

Treatment-resistant Schizophrenia

United States
University Hospital, Brest

Recruiting

Patientheque in Patients With a Psychosis . (LONGIPEP)

Schizophrenia | Schizophrenia Prodromal | Schizophrenia, Childhood

France
NYU Langone Health

Not yet recruiting

Low-Intensity Focused Ultrasound Neuromodulation of the Mediodorsal Thalamus for Treatment-Resistant Schizophrenia

Treatment-resistant Schizophrenia

United States
Johns Hopkins University
National Institute of Mental Health (NIMH)

Recruiting

Deep Brain Stimulation in Treatment Resistant Schizophrenia

Treatment-resistant Schizophrenia

United States

Clinical Trials on olanzapine pamoate depot

Children's Hospital Medical Center, Cincinnati
Watson Pharmaceuticals

Completed

Triptorelin for Ovary Protection in Childhood Onset Lupus

Systemic Lupus Erythematosus

United States, Brazil
Pharmatech
Watson Pharmaceuticals; Manyak, Michael, M.D.

Terminated

Comparison of Trelstar Versus Lupron or Zoladex in Advanced Prostate Cancer

Prostate Cancer

United States
Eli Lilly and Company

Completed

Comparison of Intramuscular Olanzapine Depot to Oral Olanzapine and Low-Dose Depot in Patients With Schizophrenia

Schizophrenic Disorders

Turkey, Finland
Immune System Regulation AB

Unknown

Efficacy and Safety of GnRH Analogue Triptorelin for HIV-1 Reservoir Reduction in ART Treated HIV-1 Infected Patients

HIV-1-infection

Sweden, Germany
Medical University of Lodz

Unknown

Evaluation of Efficacy of House Dust Mite Immunotherapy in Children With Bronchial Asthma

Asthma

Poland
University of South Florida
National Cancer Institute (NCI)

Terminated

Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer

Breast Cancer | Drug Toxicity | Hormone Changes

United States
Instituto de Investigacion Sanitaria La Fe

Completed

The Effect of Pre-treatment With GnRH Analogues Prior in Vitro Fertilization in Patients With Endometriosis (ENDOFIV)

Infertility | Endometriosis

Spain
Eli Lilly and Company

Completed

Pharmacokinetic Characterization of Intramuscular Olanzapine Depot

Schizophrenia | Schizoaffective Disorder

Australia, Belgium, Brazil, Croatia, Czech Republic, Mexico, Slovakia, Spain
Eli Lilly and Company

Completed

Comparison of Intramuscular Olanzapine Depot With Placebo in the Treatment of Patients With Schizophrenia

Schizophrenia

United States, Russian Federation, Croatia
Roxall Medicina España S.A

Completed

Dose-response Study With Subcutaneous Immunotherapy of an Standardized Dermatophagoides Pteronyssinus (DPT) Extract

Allergic Rhinoconjunctivitis

Spain

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

A Randomized, Open-label Study Comparing the Effects of Olanzapine Pamoate Depot With Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Schizophrenia

Clinical Trials on olanzapine pamoate depot

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Medical Conditions

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CROs by country

CROs in Greece

Conditions

Rare Diseases

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