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

Official Title: “An Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder”

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

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Intramuscular Olanzapine Depot
  • Intramuscular (IM) olanzapine depot flexible dosing and flexible interval

Primary Measures

• Number of Participants With Adverse Events (AE)
  • Time Frame: Randomization to end of study up to 76 months
    Safety Issue?: Yes
• 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
    Safety Issue?: Yes
• 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
    Safety Issue?: Yes
• 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
    Safety Issue?: Yes
• 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
    Safety Issue?: Yes
• Change From Baseline in Weight at Month 76 Endpoint
  • Time Frame: Baseline, up to 76 months
    Safety Issue?: Yes
• 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
    Safety Issue?: Yes
• Number of Participants With Extrapyramidal Symptoms at Any Time
  • Time Frame: Randomization to end of study up to 76 months
    Safety Issue?: Yes

Secondary Measures

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint
  • Time Frame: Baseline, up to 76 months
    Safety Issue?: No
• Change From Baseline in PANSS Positive Scores at Month 76 Endpoint
  • Time Frame: Baseline, up to 76 months
    Safety Issue?: No
• Change From Baseline in PANSS Negative Scores at Month 76 Endpoint
  • Time Frame: Baseline, up to 76 months
    Safety Issue?: No
• Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint
  • Time Frame: Baseline, up to 76 months
    Safety Issue?: No
• Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Scores at Month 72 Endpoint
  • Time Frame: Baseline, up to 72 months
    Safety Issue?: No
• 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
    Safety Issue?: No
• Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint
  • Time Frame: Baseline, up to 76 months
    Safety Issue?: No
• Number of Psychiatric Visits
  • Time Frame: Randomization to end of study up to 76 months
    Safety Issue?: No
• Days of Hospitalization
  • Time Frame: Randomization to end of study up to 76 months
    Safety Issue?: No
• 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
    Safety Issue?: No
• Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint
  • Time Frame: Randomization to end of study up to 76 months
    Safety Issue?: No
• Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year
  • Time Frame: Randomization to end of study up to 76 months
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 76 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Eli Lilly and Company Industry

Overall Clinical Trial Officials and Contacts

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) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00088465

Study ID Number: 5995

ClinicalTrials.gov Identifier: NCT00088465

Health Authority: United States: Food and Drug Administration