Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00088465
First received: July 26, 2004
Last updated: December 9, 2011
Last verified: December 2011
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Results First Received: October 14, 2011
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Conditions: |
Schizophrenic Disorders Schizoaffective Disorder |
| Intervention: |
Drug: Intramuscular olanzapine depot |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| No text entered. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Intramuscular Olanzapine Depot | Intramuscular (IM) olanzapine depot flexible dosing and flexible interval |
Participant Flow: Overall Study
| Intramuscular Olanzapine Depot | |
|---|---|
| STARTED | 931 |
| COMPLETED | 370 |
| NOT COMPLETED | 561 |
| Withdrawal by Subject | 290 |
| Adverse Event | 77 |
| Lost to Follow-up | 57 |
| Physician Decision | 45 |
| Sponsor Decision | 37 |
| Lack of Efficacy | 27 |
| Protocol Violation | 17 |
| Death | 11 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Intramuscular Olanzapine Depot | Intramuscular (IM) olanzapine depot flexible dosing and flexible interval |
Baseline Measures
| Intramuscular Olanzapine Depot | |
|---|---|
|
Number of Participants
[units: participants] |
931 |
|
Age
[units: years] Mean ± Standard Deviation |
39.32 ± 11.67 |
|
Gender
[units: participants] |
|
| Female | 310 |
| Male | 621 |
|
Race/Ethnicity, Customized
[units: participants] |
|
| African | 102 |
| Caucasian | 629 |
| East Asian | 39 |
| Hispanic | 140 |
| Native American | 2 |
| West Asian | 19 |
|
Region of Enrollment
[units: participants] |
|
| United States | 177 |
| Portugal | 18 |
| Taiwan | 30 |
| Slovakia | 13 |
| Spain | 24 |
| Russian Federation | 114 |
| Israel | 29 |
| Italy | 6 |
| France | 55 |
| Puerto Rico | 27 |
| Australia | 11 |
| South Africa | 28 |
| Netherlands | 8 |
| Austria | 10 |
| Czech Republic | 3 |
| Hungary | 13 |
| Mexico | 63 |
| Argentina | 73 |
| Poland | 33 |
| Brazil | 89 |
| Belgium | 13 |
| Croatia | 16 |
| Romania | 34 |
| Germany | 32 |
| Sweden | 9 |
| Greece | 3 |
Outcome Measures
| 1. Primary: | Number of Participants With Adverse Events (AE) [ Time Frame: Randomization to end of study up to 76 months ] |
| 2. Primary: | Number of Participants With Treatment-Emergent Abnormal High Prolactin at Any Time Post Baseline [ Time Frame: Randomization to end of study up to 76 months ] |
| 3. Primary: | Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline [ Time Frame: Randomization to end of study up to 76 months ] |
| 4. Primary: | Number of Participants Having Normal Fasting Baseline Glucose Value With Treatment-Emergent High Fasting Glucose at Any Time Post Baseline [ Time Frame: Randomization to end of study up to 76 months ] |
| 5. Primary: | Number of Participants Having Normal Fasting Baseline Lipid Value With Treatment-Emergent High Fasting Lipid at Any Time Post Baseline [ Time Frame: Randomization to end of study up to 76 months ] |
| 6. Primary: | Change From Baseline in Weight at Month 76 Endpoint [ Time Frame: Baseline, up to 76 months ] |
| 7. Primary: | Number of Participants With Potentially Clinically Significant (PCS) Weight Gain at Month 76 Endpoint [ Time Frame: Randomization to end of study up to 76 months ] |
| 8. Primary: | Number of Participants With Extrapyramidal Symptoms at Any Time [ Time Frame: Randomization to end of study up to 76 months ] |
| 9. Secondary: | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint [ Time Frame: Baseline, up to 76 months ] |
| 10. Secondary: | Change From Baseline in PANSS Positive Scores at Month 76 Endpoint [ Time Frame: Baseline, up to 76 months ] |
| 11. Secondary: | Change From Baseline in PANSS Negative Scores at Month 76 Endpoint [ Time Frame: Baseline, up to 76 months ] |
| 12. Secondary: | Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint [ Time Frame: Baseline, up to 76 months ] |
| 13. Secondary: | Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Scores at Month 72 Endpoint [ Time Frame: Baseline, up to 72 months ] |
| 14. Secondary: | Change From Baseline in the Heinrichs-Carpenter Quality of Life Scale (QLS) Total Score at Month 76 Endpoint [ Time Frame: Baseline, up to 76 months ] |
| 15. Secondary: | Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint [ Time Frame: Baseline, up to 76 months ] |
| 16. Secondary: | Number of Psychiatric Visits [ Time Frame: Randomization to end of study up to 76 months ] |
| 17. Secondary: | Days of Hospitalization [ Time Frame: Randomization to end of study up to 76 months ] |
| 18. Secondary: | Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) at Month 76 Endpoint [ Time Frame: Baseline, up to 76 months ] |
| 19. Secondary: | Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint [ Time Frame: Randomization to end of study up to 76 months ] |
| 20. Secondary: | Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year [ Time Frame: Randomization to end of study up to 76 months ] |