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Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00088465
Collaborator
(none)
931
Enrollment
92
Locations
1
Arm
76
Duration (Months)
10.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a long-term, open-label clinical study designed to enable longer-term treatment of patients completing other clinical studies with intramuscular olanzapine depot.

Key objectives of the study are to:

  • Determine how well intramuscular (IM) olanzapine depot works during long-term treatment,

  • Evaluate the safety and tolerability of IM olanzapine depot during long-term treatment,

  • Determine the blood levels of IM olanzapine depot in patients during long-term treatment

Condition or Disease Intervention/Treatment Phase
  • Drug: Intramuscular olanzapine depot
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
931 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder
Study Start Date :
Aug 1, 2004
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intramuscular Olanzapine Depot

Intramuscular (IM) olanzapine depot flexible dosing and flexible interval

Drug: Intramuscular olanzapine depot
45-405 milligram (mg), intramuscular injection, on a 2-, 3-, or 4-week interval.
Other Names:
  • LY170053
  • Zyprexa Adhera

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Adverse Events (AE) [Randomization to end of study up to 76 months]

      The list of serious adverse events (SAE) and other non-serious adverse events (AE) are in Adverse Events Section.

    2. Number of Participants With Treatment-Emergent Abnormal High Prolactin at Any Time Post Baseline [Randomization to end of study up to 76 months]

      Prolactin normal reference ranges for female: 2.0 - 29.0 nanograms per milliliter (ng/mL); male: 2.0 - 20.0 ng/mL. High value is defined as a change from a value less than or equal to the high limit at all baseline visits to a value greater than the high limit at any time after baseline.

    3. Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline [Randomization to end of study up to 76 months]

      High ALT is defined as a baseline value of <3 times the upper limit of normal (ULN) to ≥3 times the ULN at any time post baseline. High AST is defined as a baseline value of <5 times the ULN to ≥5 times the ULN at any time post baseline. High total bilirubin is defined as a baseline value of <2 times the ULN to ≥2 times the ULN at any time post baseline.

    4. Number of Participants Having Normal Fasting Baseline Glucose Value With Treatment-Emergent High Fasting Glucose at Any Time Post Baseline [Randomization to end of study up to 76 months]

      Normal to high fasting glucose ≤100 milligrams per deciliter (mg/dL) at baseline to ≥126 mg/dL any time post baseline.

    5. Number of Participants Having Normal Fasting Baseline Lipid Value With Treatment-Emergent High Fasting Lipid at Any Time Post Baseline [Randomization to end of study up to 76 months]

      Normal to high fasting total cholesterol ≤200 mg/dL at baseline to ≥240 mg/dL any time post baseline. Fasting triglycerides <150 mg/dL at baseline to ≥200 mg/dL and <500 mg/dL any time post baseline.

    6. Change From Baseline in Weight at Month 76 Endpoint [Baseline, up to 76 months]

      Mean change in weight from baseline to last observation carried forward (LOCF) endpoint.

    7. Number of Participants With Potentially Clinically Significant (PCS) Weight Gain at Month 76 Endpoint [Randomization to end of study up to 76 months]

      PCS weight gain is defined as a ≥7% increase in weight from baseline.

    8. Number of Participants With Extrapyramidal Symptoms at Any Time [Randomization to end of study up to 76 months]

      Extrapyramidal symptoms are defined as Simpson-Angus total score (SAS) >3 at any post-baseline visit; Barnes Akathisia Scale (BAS) global score ≥2 at any post-baseline visit; A score ≥3 for any of Abnormal Involuntary Movement Scale (AIMS) for items 1-7 or a score ≥2 for any two of these items. Score for SAS is 0-4 for each of the 10 questions, with 0=normal and 4=extreme. The possible total score for SAS is 0-40. Possible score for BAS is 0-5, with 0=absent and 5=sever. Score 0-4 for each item of AIMS, with 0 =none and 4= sever. Possible total score for items 1-7 is 0-28.

    Secondary Outcome Measures

    1. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint [Baseline, up to 76 months]

      Assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210.

    2. Change From Baseline in PANSS Positive Scores at Month 76 Endpoint [Baseline, up to 76 months]

      PANSS questions 1-7. Assesses positive symptoms associated with schizophrenia. 7 items make up the positive scale (ex. delusions, conceptual disorganization, and hallucinatory behavior). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total positive subscale scores range from 7 to 49.

    3. Change From Baseline in PANSS Negative Scores at Month 76 Endpoint [Baseline, up to 76 months]

      PANSS questions 8-14. Assesses negative symptoms associated with schizophrenia. 7 items make up the negative scale (e.g. blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total negative subscale scores range from 7 to 49.

    4. Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint [Baseline, up to 76 months]

      PANSS General Psychopathology Subscale is the Remaining 16 PANSS questions or PANSS Question15 through Question 30. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 16 items is defined as the PANSS General Psychopathology Subscales. Possible score ranges from 16 to 112.

    5. Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Scores at Month 72 Endpoint [Baseline, up to 72 months]

      Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

    6. Change From Baseline in the Heinrichs-Carpenter Quality of Life Scale (QLS) Total Score at Month 76 Endpoint [Baseline, up to 76 months]

      Heinrich-Carpenter QLS is an interviewer-rated scale which measures the impact of negative symptoms on occupational, social, and psychological functioning in patients with schizophrenia or schizoaffective disorder. Each of 21 items is rated on a scale from 0 (severely impaired functioning) to 6 (normal or adequate functioning), for a total score range of 0-126. Results are presented as change in Total score.

    7. Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint [Baseline, up to 76 months]

      A self-reported questionnaire that consists of 36 questions covering 8 health domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The mental component summary (MCS) and the physical component summary (PCS) have been constructed based on the 8 SF-36 domains.

    8. Number of Psychiatric Visits [Randomization to end of study up to 76 months]

      Psychiatric visits were outpatient visits to a psychiatrist or psychiatric nurse.

    9. Days of Hospitalization [Randomization to end of study up to 76 months]

      This is the total number of days for all hospitalized patients that were admitted to General, Psychiatric Ward as well as Intensive Care Unit (ICU).

    10. Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) at Month 76 Endpoint [Baseline, up to 76 months]

      The Subjective Well-Being under Neuroleptic Treatment-Short Form (SWN-S) is a patient self-rated scale developed to measure the subjective well-being for the previous 7 days of a patient under neuroleptic treatment. The SWN-S consists of 20 items (each item is rated from 1=not at all to 6=very much). Possible total score ranges from 20-120.

    11. Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint [Randomization to end of study up to 76 months]

      Self-rated scale that measures patient's level of satisfaction with current antipsychotic medication. Consists of 3 items assessing satisfaction with current study medication (scored from 1='very dissatisfied' to 5='very satisfied'), preference comparing current study medication versus previous medications (scored from 1='much prefer previous medication' to 5='much prefer study medication'), and side effects of current study medication compared with previous medications (scored from 1='much less side effects' to 5='much more side effects'). Range of possible scores is 3-15.

    12. Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year [Randomization to end of study up to 76 months]

      Plasma olanzapine concentrations are expressed as (nanogram/milliliter)/(milligram/day) ([ng/mL]/[mg/day]).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 76 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients must have schizophrenia

    • Female patients of childbearing potential must be using a medically accepted means of contraception

    • Patients must have completed (within 10 days) another IM olanzapine depot study if permitted by that study's protocol.

    Exclusion Criteria:

    • Patients must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to study entry

    • Female patients must not be pregnant or breast-feeding

    • Patients must not be experiencing acute, serious or unstable medical conditions other than schizophrenia or schizoaffective disorder

    • Patients must not have a substance (except nicotine or caffeine) dependence within the past 30 days

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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
    2 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. Pasadena California United States 91107
    3 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
    4 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. Santa Ana California United States 92705
    5 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. Washington District of Columbia United States 20016
    6 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. Bradenton Florida United States 34208
    7 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. Honolulu Hawaii United States 96826
    8 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. Chicago Illinois United States 60640
    9 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. Indianapolis Indiana United States 46222
    10 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. Lake Charles Louisiana United States 70601
    11 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. St Louis Missouri United States 63118
    12 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. Las Vegas Nevada United States 89102
    13 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. Reno Nevada United States 89512
    14 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. Albuquerque New Mexico United States 87131
    15 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. Cedarhurst New York United States 11516
    16 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 New York United States 10035
    17 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. Rochester New York United States 14624
    18 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. Chagrin Falls Ohio United States 44022
    19 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. Chardon Ohio United States 44024
    20 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. Houston Texas United States 77007
    21 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. Kirkland Washington United States 98033
    22 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 1221
    23 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. Lanus Este Argentina B18241BR
    24 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. Mendoza Argentina M5500GAC
    25 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. Herston Queensland Australia 4029
    26 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. Glenside South Australia Australia 5065
    27 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. Dandenong Victoria Australia 3175
    28 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. Wien Austria 1010
    29 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. Diest Belgium 3290
    30 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. Liège Belgium 4000
    31 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. Aparecida De Goiania Brazil 74922-810
    32 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 De Janeiro Brazil 21020-130
    33 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. Salvador Brazil 40301500
    34 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. Zagreb Croatia 10000
    35 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. Prague Czech Republic 181 03
    36 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. Bayonne France 64109
    37 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. Bourg En Bresse France 01000
    38 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. Dijon France 21033
    39 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. Dole France 39100
    40 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. Fontaine France 38600
    41 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 Roche Sur Foron France 74800
    42 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
    43 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. Limoges France 87025
    44 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. Narbonne France 11108
    45 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. Paris France 75674
    46 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. Saint Cyr Au Mont D'Or France 69450
    47 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
    48 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. Suresnes France 92150
    49 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. Bad Saarow Germany D-15526
    50 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. Berlin Germany 10117
    51 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. Halle Germany D-06097
    52 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. Hamburg Germany D-20251
    53 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. Mainz Germany D-55101
    54 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. München Germany D-81675
    55 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. Budapest Hungary 1083
    56 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. Beer Yaacov Israel 70350
    57 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. Hod-Hasharon Israel 45100
    58 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. Lev Hasharon Israel 42100
    59 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. Firenze Italy 50134
    60 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. Savigliano Italy 12038
    61 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. Torino Italy 10126
    62 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. Guadalajara Mexico 45170
    63 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. Mexico City Mexico 14420
    64 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. Monterrey Mexico 64000
    65 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. Den Haag Netherlands 2553 RJ
    66 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. Enschede Netherlands 7546 TA
    67 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. Gdynia Poland 81-361
    68 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. Torun Poland 87 100
    69 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. Braga Portugal 4710-200
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    Sponsors and Collaborators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT00088465
    Other Study ID Numbers:
    • 5995
    • F1D-MC-HGKB
    First Posted:
    Jul 27, 2004
    Last Update Posted:
    Jan 11, 2012
    Last Verified:
    Dec 1, 2011
    Additional relevant MeSH terms:
    Disease
    Schizophrenia
    Psychotic Disorders
    Olanzapine

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Intramuscular Olanzapine Depot
    Arm/Group Description Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
    Period Title: Overall Study
    STARTED 931
    COMPLETED 370
    NOT COMPLETED 561

    Baseline Characteristics

    Arm/Group Title Intramuscular Olanzapine Depot
    Arm/Group Description Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
    Overall Participants 931
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    39.32
    (11.67)
    Sex: Female, Male (Count of Participants)
    Female
    310
    33.3%
    Male
    621
    66.7%
    Race/Ethnicity, Customized (participants) [Number]
    African
    102
    11%
    Caucasian
    629
    67.6%
    East Asian
    39
    4.2%
    Hispanic
    140
    15%
    Native American
    2
    0.2%
    West Asian
    19
    2%
    Region of Enrollment (participants) [Number]
    United States
    177
    19%
    Portugal
    18
    1.9%
    Taiwan
    30
    3.2%
    Slovakia
    13
    1.4%
    Spain
    24
    2.6%
    Russian Federation
    114
    12.2%
    Israel
    29
    3.1%
    Italy
    6
    0.6%
    France
    55
    5.9%
    Puerto Rico
    27
    2.9%
    Australia
    11
    1.2%
    South Africa
    28
    3%
    Netherlands
    8
    0.9%
    Austria
    10
    1.1%
    Czech Republic
    3
    0.3%
    Hungary
    13
    1.4%
    Mexico
    63
    6.8%
    Argentina
    73
    7.8%
    Poland
    33
    3.5%
    Brazil
    89
    9.6%
    Belgium
    13
    1.4%
    Croatia
    16
    1.7%
    Romania
    34
    3.7%
    Germany
    32
    3.4%
    Sweden
    9
    1%
    Greece
    3
    0.3%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Adverse Events (AE)
    Description The list of serious adverse events (SAE) and other non-serious adverse events (AE) are in Adverse Events Section.
    Time Frame Randomization to end of study up to 76 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who took at least one dose of study drug.
    Arm/Group Title Intramuscular Olanzapine Depot
    Arm/Group Description Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
    Measure Participants 931
    AE
    501
    53.8%
    SAE
    170
    18.3%
    2. Secondary Outcome
    Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint
    Description Assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210.
    Time Frame Baseline, up to 76 months

    Outcome Measure Data

    Analysis Population Description
    Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).
    Arm/Group Title Intramuscular Olanzapine Depot
    Arm/Group Description Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
    Measure Participants 856
    Mean (Standard Deviation) [units on a scale]
    0.30
    (16.42)
    3. Secondary Outcome
    Title Change From Baseline in PANSS Positive Scores at Month 76 Endpoint
    Description PANSS questions 1-7. Assesses positive symptoms associated with schizophrenia. 7 items make up the positive scale (ex. delusions, conceptual disorganization, and hallucinatory behavior). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total positive subscale scores range from 7 to 49.
    Time Frame Baseline, up to 76 months

    Outcome Measure Data

    Analysis Population Description
    Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).
    Arm/Group Title Intramuscular Olanzapine Depot
    Arm/Group Description Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
    Measure Participants 856
    Mean (Standard Deviation) [units on a scale]
    0.21
    (4.69)
    4. Secondary Outcome
    Title Change From Baseline in PANSS Negative Scores at Month 76 Endpoint
    Description PANSS questions 8-14. Assesses negative symptoms associated with schizophrenia. 7 items make up the negative scale (e.g. blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total negative subscale scores range from 7 to 49.
    Time Frame Baseline, up to 76 months

    Outcome Measure Data

    Analysis Population Description
    Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).
    Arm/Group Title Intramuscular Olanzapine Depot
    Arm/Group Description Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
    Measure Participants 856
    Mean (Standard Deviation) [units on a scale]
    -0.08
    (5.14)
    5. Secondary Outcome
    Title Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint
    Description PANSS General Psychopathology Subscale is the Remaining 16 PANSS questions or PANSS Question15 through Question 30. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 16 items is defined as the PANSS General Psychopathology Subscales. Possible score ranges from 16 to 112.
    Time Frame Baseline, up to 76 months

    Outcome Measure Data

    Analysis Population Description
    Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).
    Arm/Group Title Intramuscular Olanzapine Depot
    Arm/Group Description Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
    Measure Participants 856
    Mean (Standard Deviation) [units on a scale]
    0.19
    (8.51)
    6. Secondary Outcome
    Title Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Scores at Month 72 Endpoint
    Description Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
    Time Frame Baseline, up to 72 months

    Outcome Measure Data

    Analysis Population Description
    Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).
    Arm/Group Title Intramuscular Olanzapine Depot
    Arm/Group Description Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
    Measure Participants 920
    Mean (Standard Error) [units on a scale]
    -0.17
    (0.03)
    7. Secondary Outcome
    Title Change From Baseline in the Heinrichs-Carpenter Quality of Life Scale (QLS) Total Score at Month 76 Endpoint
    Description Heinrich-Carpenter QLS is an interviewer-rated scale which measures the impact of negative symptoms on occupational, social, and psychological functioning in patients with schizophrenia or schizoaffective disorder. Each of 21 items is rated on a scale from 0 (severely impaired functioning) to 6 (normal or adequate functioning), for a total score range of 0-126. Results are presented as change in Total score.
    Time Frame Baseline, up to 76 months

    Outcome Measure Data

    Analysis Population Description
    Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).
    Arm/Group Title Intramuscular Olanzapine Depot
    Arm/Group Description Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
    Measure Participants 852
    Mean (Standard Deviation) [units on a scale]
    6.75
    (18.55)
    8. Secondary Outcome
    Title Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint
    Description A self-reported questionnaire that consists of 36 questions covering 8 health domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The mental component summary (MCS) and the physical component summary (PCS) have been constructed based on the 8 SF-36 domains.
    Time Frame Baseline, up to 76 months

    Outcome Measure Data

    Analysis Population Description
    Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).
    Arm/Group Title Intramuscular Olanzapine Depot
    Arm/Group Description Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
    Measure Participants 850
    Mental component summary
    0.94
    (11.05)
    Physical component summary
    -0.36
    (8.34)
    9. Secondary Outcome
    Title Number of Psychiatric Visits
    Description Psychiatric visits were outpatient visits to a psychiatrist or psychiatric nurse.
    Time Frame Randomization to end of study up to 76 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who took at least one dose of study drug.
    Arm/Group Title Intramuscular Olanzapine Depot
    Arm/Group Description Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
    Measure Participants 931
    Number [visits]
    14102
    10. Secondary Outcome
    Title Days of Hospitalization
    Description This is the total number of days for all hospitalized patients that were admitted to General, Psychiatric Ward as well as Intensive Care Unit (ICU).
    Time Frame Randomization to end of study up to 76 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who took at least one dose of study drug.
    Arm/Group Title Intramuscular Olanzapine Depot
    Arm/Group Description Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
    Measure Participants 931
    Regular hospital
    2386
    Psychiatric hospital
    35587
    ICU
    134
    11. Secondary Outcome
    Title Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) at Month 76 Endpoint
    Description The Subjective Well-Being under Neuroleptic Treatment-Short Form (SWN-S) is a patient self-rated scale developed to measure the subjective well-being for the previous 7 days of a patient under neuroleptic treatment. The SWN-S consists of 20 items (each item is rated from 1=not at all to 6=very much). Possible total score ranges from 20-120.
    Time Frame Baseline, up to 76 months

    Outcome Measure Data

    Analysis Population Description
    Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).
    Arm/Group Title Intramuscular Olanzapine Depot
    Arm/Group Description Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
    Measure Participants 755
    Mean (Standard Deviation) [units on a scale]
    0.86
    (15.96)
    12. Secondary Outcome
    Title Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint
    Description Self-rated scale that measures patient's level of satisfaction with current antipsychotic medication. Consists of 3 items assessing satisfaction with current study medication (scored from 1='very dissatisfied' to 5='very satisfied'), preference comparing current study medication versus previous medications (scored from 1='much prefer previous medication' to 5='much prefer study medication'), and side effects of current study medication compared with previous medications (scored from 1='much less side effects' to 5='much more side effects'). Range of possible scores is 3-15.
    Time Frame Randomization to end of study up to 76 months

    Outcome Measure Data

    Analysis Population Description
    All randomized participants.
    Arm/Group Title Intramuscular Olanzapine Depot
    Arm/Group Description Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
    Measure Participants 931
    Depot, somewhat or very satisfied
    73.2
    7.9%
    Depot vs. oral, prefer or much prefer
    66.8
    7.2%
    Depot vs. oral, less or much less side effects
    73.3
    7.9%
    13. Secondary Outcome
    Title Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year
    Description Plasma olanzapine concentrations are expressed as (nanogram/milliliter)/(milligram/day) ([ng/mL]/[mg/day]).
    Time Frame Randomization to end of study up to 76 months

    Outcome Measure Data

    Analysis Population Description
    Participants who took at least one dose of study drug and had post-baseline measurements.
    Arm/Group Title Intramuscular Olanzapine Depot
    Arm/Group Description Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
    Measure Participants 931
    0.25 year (n= 130)
    2.23
    (1.34)
    1 year (n= 189)
    2.51
    (1.30)
    2 years (n= 166)
    2.45
    (1.32)
    3 years (n= 148)
    2.65
    (1.39)
    4 years (n= 109)
    2.57
    (1.72)
    5 years (n= 87)
    2.59
    (1.46)
    6 years (n= 28)
    2.73
    (1.25)
    14. Primary Outcome
    Title Number of Participants With Treatment-Emergent Abnormal High Prolactin at Any Time Post Baseline
    Description Prolactin normal reference ranges for female: 2.0 - 29.0 nanograms per milliliter (ng/mL); male: 2.0 - 20.0 ng/mL. High value is defined as a change from a value less than or equal to the high limit at all baseline visits to a value greater than the high limit at any time after baseline.
    Time Frame Randomization to end of study up to 76 months

    Outcome Measure Data

    Analysis Population Description
    Participants with normal baseline and at least one post-baseline measurement.
    Arm/Group Title Intramuscular Olanzapine Depot
    Arm/Group Description Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
    Measure Participants 430
    Number [participants]
    100
    10.7%
    15. Primary Outcome
    Title Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline
    Description High ALT is defined as a baseline value of <3 times the upper limit of normal (ULN) to ≥3 times the ULN at any time post baseline. High AST is defined as a baseline value of <5 times the ULN to ≥5 times the ULN at any time post baseline. High total bilirubin is defined as a baseline value of <2 times the ULN to ≥2 times the ULN at any time post baseline.
    Time Frame Randomization to end of study up to 76 months

    Outcome Measure Data

    Analysis Population Description
    Participants with normal baseline and at least one post-baseline measurement.
    Arm/Group Title Intramuscular Olanzapine Depot
    Arm/Group Description Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
    Measure Participants 931
    ALT (n=901)
    61
    6.6%
    AST (n=909)
    55
    5.9%
    Total Bilirubin (n=912)
    24
    2.6%
    16. Primary Outcome
    Title Number of Participants Having Normal Fasting Baseline Glucose Value With Treatment-Emergent High Fasting Glucose at Any Time Post Baseline
    Description Normal to high fasting glucose ≤100 milligrams per deciliter (mg/dL) at baseline to ≥126 mg/dL any time post baseline.
    Time Frame Randomization to end of study up to 76 months

    Outcome Measure Data

    Analysis Population Description
    Participants with normal baseline and at least one post-baseline measurement.
    Arm/Group Title Intramuscular Olanzapine Depot
    Arm/Group Description Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
    Measure Participants 864
    Number [participants]
    20
    2.1%
    17. Primary Outcome
    Title Number of Participants Having Normal Fasting Baseline Lipid Value With Treatment-Emergent High Fasting Lipid at Any Time Post Baseline
    Description Normal to high fasting total cholesterol ≤200 mg/dL at baseline to ≥240 mg/dL any time post baseline. Fasting triglycerides <150 mg/dL at baseline to ≥200 mg/dL and <500 mg/dL any time post baseline.
    Time Frame Randomization to end of study up to 76 months

    Outcome Measure Data

    Analysis Population Description
    Participants with normal baseline and at least one post-baseline measurement.
    Arm/Group Title Intramuscular Olanzapine Depot
    Arm/Group Description Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
    Measure Participants 931
    Cholesterol (n=873)
    28
    3%
    Triglycerides (n=879)
    41
    4.4%
    18. Primary Outcome
    Title Change From Baseline in Weight at Month 76 Endpoint
    Description Mean change in weight from baseline to last observation carried forward (LOCF) endpoint.
    Time Frame Baseline, up to 76 months

    Outcome Measure Data

    Analysis Population Description
    Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).
    Arm/Group Title Intramuscular Olanzapine Depot
    Arm/Group Description Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
    Measure Participants 919
    Mean (Standard Deviation) [kilogram (kg)]
    2.10
    (7.81)
    19. Primary Outcome
    Title Number of Participants With Potentially Clinically Significant (PCS) Weight Gain at Month 76 Endpoint
    Description PCS weight gain is defined as a ≥7% increase in weight from baseline.
    Time Frame Randomization to end of study up to 76 months

    Outcome Measure Data

    Analysis Population Description
    Participants with normal baseline and at least one post-baseline measurement.
    Arm/Group Title Intramuscular Olanzapine Depot
    Arm/Group Description Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
    Measure Participants 919
    Number [participants]
    373
    40.1%
    20. Primary Outcome
    Title Number of Participants With Extrapyramidal Symptoms at Any Time
    Description Extrapyramidal symptoms are defined as Simpson-Angus total score (SAS) >3 at any post-baseline visit; Barnes Akathisia Scale (BAS) global score ≥2 at any post-baseline visit; A score ≥3 for any of Abnormal Involuntary Movement Scale (AIMS) for items 1-7 or a score ≥2 for any two of these items. Score for SAS is 0-4 for each of the 10 questions, with 0=normal and 4=extreme. The possible total score for SAS is 0-40. Possible score for BAS is 0-5, with 0=absent and 5=sever. Score 0-4 for each item of AIMS, with 0 =none and 4= sever. Possible total score for items 1-7 is 0-28.
    Time Frame Randomization to end of study up to 76 months

    Outcome Measure Data

    Analysis Population Description
    Participants with a baseline and at least one post-baseline measurement.
    Arm/Group Title Intramuscular Olanzapine Depot
    Arm/Group Description Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
    Measure Participants 931
    SAS (n=819)
    66
    7.1%
    BAS (n=856)
    34
    3.7%
    AIMS (n=860)
    28
    3%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Intramuscular Olanzapine Depot
    Arm/Group Description Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
    All Cause Mortality
    Intramuscular Olanzapine Depot
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Intramuscular Olanzapine Depot
    Affected / at Risk (%) # Events
    Total 170/931 (18.3%)
    Blood and lymphatic system disorders
    Iron deficiency anaemia 1/931 (0.1%) 1
    Cardiac disorders
    Cardiac failure 1/931 (0.1%) 1
    Cardiac failure acute 1/931 (0.1%) 1
    Cardiomyopathy alcoholic 1/931 (0.1%) 1
    Hypertrophic cardiomyopathy 1/931 (0.1%) 1
    Myocardial infarction 3/931 (0.3%) 3
    Myocardial ischaemia 1/931 (0.1%) 1
    Ventricular tachycardia 1/931 (0.1%) 1
    Gastrointestinal disorders
    Abdominal discomfort 1/931 (0.1%) 1
    Abdominal pain 1/931 (0.1%) 1
    Abdominal pain upper 1/931 (0.1%) 2
    Diarrhoea 1/931 (0.1%) 1
    Dry mouth 1/931 (0.1%) 1
    Inguinal hernia 1/931 (0.1%) 1
    Intestinal ischaemia 1/931 (0.1%) 1
    Intestinal perforation 1/931 (0.1%) 1
    Subileus 1/931 (0.1%) 1
    Toothache 1/931 (0.1%) 1
    General disorders
    Asthenia 2/931 (0.2%) 2
    Fatigue 2/931 (0.2%) 2
    Malaise 3/931 (0.3%) 3
    Hepatobiliary disorders
    Hepatotoxicity 1/931 (0.1%) 1
    Infections and infestations
    Abscess 1/931 (0.1%) 1
    Abscess limb 1/931 (0.1%) 1
    Appendicitis 2/931 (0.2%) 2
    Breast cellulitis 1/931 (0.1%) 1
    Cellulitis 3/931 (0.3%) 3
    Ear infection 1/931 (0.1%) 1
    Gastroenteritis 1/931 (0.1%) 1
    Leptospirosis 1/931 (0.1%) 1
    Lobar pneumonia 1/931 (0.1%) 1
    Pneumonia 2/931 (0.2%) 2
    Pyelonephritis acute 2/931 (0.2%) 2
    Septic shock 1/931 (0.1%) 1
    Urinary tract infection 2/931 (0.2%) 2
    Injury, poisoning and procedural complications
    Brain contusion 1/931 (0.1%) 1
    Drug exposure during pregnancy 1/931 (0.1%) 1
    Fall 2/931 (0.2%) 2
    Joint dislocation 1/931 (0.1%) 1
    Lower limb fracture 1/931 (0.1%) 1
    Overdose 3/931 (0.3%) 3
    Post procedural complication 2/931 (0.2%) 4
    Rib fracture 1/931 (0.1%) 1
    Road traffic accident 1/931 (0.1%) 1
    Skull fractured base 1/931 (0.1%) 1
    Subdural haematoma 1/931 (0.1%) 1
    Tendon rupture 1/931 (0.1%) 1
    Tibia fracture 1/931 (0.1%) 1
    Traumatic brain injury 1/931 (0.1%) 1
    Traumatic lung injury 1/931 (0.1%) 1
    Investigations
    Blood glucose increased 1/931 (0.1%) 1
    Blood potassium decreased 1/931 (0.1%) 1
    Blood pressure decreased 1/931 (0.1%) 1
    Laboratory test abnormal 1/931 (0.1%) 1
    Metabolism and nutrition disorders
    Diabetes mellitus 2/931 (0.2%) 2
    Diabetic ketoacidosis 1/931 (0.1%) 1
    Electrolyte imbalance 1/931 (0.1%) 1
    Hypokalaemia 1/931 (0.1%) 1
    Polydipsia 1/931 (0.1%) 1
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion 1/931 (0.1%) 2
    Muscle spasms 1/931 (0.1%) 1
    Osteoarthritis 1/931 (0.1%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder neoplasm 1/931 (0.1%) 1
    Breast cancer 2/931 (0.2%) 2
    Metastases to bone 1/931 (0.1%) 1
    Metastatic renal cell carcinoma 1/931 (0.1%) 1
    Neoplasm 1/931 (0.1%) 1
    Non-small cell lung cancer 1/931 (0.1%) 1
    Renal cell carcinoma 1/931 (0.1%) 1
    Small cell lung cancer stage unspecified 1/931 (0.1%) 1
    Nervous system disorders
    Cauda equina syndrome 1/931 (0.1%) 2
    Cerebral haematoma 1/931 (0.1%) 1
    Cerebrovascular accident 1/931 (0.1%) 1
    Cervicobrachial syndrome 1/931 (0.1%) 2
    Coma 1/931 (0.1%) 1
    Dizziness 3/931 (0.3%) 3
    Dysarthria 1/931 (0.1%) 1
    Headache 1/931 (0.1%) 2
    Loss of consciousness 2/931 (0.2%) 2
    Parkinsonism 1/931 (0.1%) 2
    Sedation 12/931 (1.3%) 13
    Somnolence 5/931 (0.5%) 5
    Subarachnoid haemorrhage 1/931 (0.1%) 1
    Tremor 1/931 (0.1%) 1
    Psychiatric disorders
    Abnormal behaviour 1/931 (0.1%) 1
    Acute stress disorder 1/931 (0.1%) 1
    Aggression 4/931 (0.4%) 5
    Agitation 6/931 (0.6%) 7
    Alcohol abuse 1/931 (0.1%) 1
    Anxiety 5/931 (0.5%) 6
    Completed suicide 1/931 (0.1%) 1
    Confusional state 4/931 (0.4%) 5
    Delirium 4/931 (0.4%) 4
    Delusion 1/931 (0.1%) 1
    Depression 5/931 (0.5%) 5
    Disorientation 1/931 (0.1%) 2
    Emotional disorder 1/931 (0.1%) 1
    Hallucination 1/931 (0.1%) 1
    Hallucination, auditory 2/931 (0.2%) 2
    Impulsive behaviour 1/931 (0.1%) 2
    Mental status changes 1/931 (0.1%) 1
    Paranoia 5/931 (0.5%) 5
    Psychotic disorder 20/931 (2.1%) 21
    Restlessness 1/931 (0.1%) 2
    Schizophrenia 35/931 (3.8%) 38
    Schizophrenia, paranoid type 1/931 (0.1%) 1
    Suicidal behaviour 1/931 (0.1%) 1
    Suicidal ideation 8/931 (0.9%) 9
    Suicide attempt 4/931 (0.4%) 4
    Vomiting psychogenic 1/931 (0.1%) 1
    Renal and urinary disorders
    Urinary incontinence 1/931 (0.1%) 1
    Urinary retention 1/931 (0.1%) 2
    Reproductive system and breast disorders
    Menorrhagia 1/931 (0.1%) 1
    Respiratory, thoracic and mediastinal disorders
    Asthma 1/931 (0.1%) 1
    Chronic obstructive pulmonary disease 1/931 (0.1%) 2
    Dyspnoea 1/931 (0.1%) 1
    Haemothorax 1/931 (0.1%) 1
    Pneumonia aspiration 1/931 (0.1%) 1
    Respiratory failure 1/931 (0.1%) 1
    Skin and subcutaneous tissue disorders
    Acne 1/931 (0.1%) 1
    Dermatitis 2/931 (0.2%) 3
    Social circumstances
    Social stay hospitalisation 1/931 (0.1%) 1
    Surgical and medical procedures
    Plastic surgery 1/931 (0.1%) 1
    Vascular disorders
    Hypertension 3/931 (0.3%) 4
    Peripheral arterial occlusive disease 1/931 (0.1%) 1
    Thrombophlebitis 1/931 (0.1%) 1
    Venous thrombosis limb 1/931 (0.1%) 1
    Other (Not Including Serious) Adverse Events
    Intramuscular Olanzapine Depot
    Affected / at Risk (%) # Events
    Total 501/931 (53.8%)
    Infections and infestations
    Nasopharyngitis 74/931 (7.9%) 84
    Investigations
    Weight increased 134/931 (14.4%) 136
    Nervous system disorders
    Dizziness 50/931 (5.4%) 57
    Headache 67/931 (7.2%) 72
    Somnolence 85/931 (9.1%) 101
    Psychiatric disorders
    Anxiety 90/931 (9.7%) 94
    Depression 48/931 (5.2%) 48
    Insomnia 90/931 (9.7%) 92

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT00088465
    Other Study ID Numbers:
    • 5995
    • F1D-MC-HGKB
    First Posted:
    Jul 27, 2004
    Last Update Posted:
    Jan 11, 2012
    Last Verified:
    Dec 1, 2011