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

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2010

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • IM olanzapine depot flexible dosing and flexible interval

Primary Measures

• To assess the long-term safety of IM olanzapine depot in patients diagnosed with schizophrenia and schizoaffective disorder by monitoring laboratory values, vital signs, electrocardiograms, adverse events, and extrapyramidal symptoms.
  • Time Frame: Randomization to end of study
    Safety Issue?: Yes

Secondary Measures

• To assess long-term efficacy of IM olanzapine depot in patients diagnosed with schizophrenia or schizoaffective disorder by measuring Positive and Negative Syndrome Scale (PANSS) Total scores.
  • Time Frame: Randomization to end of study
    Safety Issue?: No
• To assess the long-term efficacy of IM olanzapine depot in patients diagnosed with schizophrenia or schizoaffective disorder by measuring the PANSS Positive scores.
  • Time Frame: Randomization to end of study
    Safety Issue?: No
• To assess the long-term efficacy of IM olanzapine depot in patients diagnosed with schizophrenia or schizoaffective disorder by measuring the PANSS Negative scores.
  • Time Frame: Randomization to end of study
    Safety Issue?: No
• To assess the long-term efficacy of IM olanzapine depot in patients diagnosed with schizophrenia or schizoaffective disorder by measuring the PANSS General Psychopathology Subscales.
  • Time Frame: Randomization to end of study
    Safety Issue?: No
• To assess the long-term efficacy of IM olanzapine depot in patients diagnosed with schizophrenia or schizoaffective disorder by measuring Clinical Global Impression-Severity of Illness (CGI-S) scores.
  • Time Frame: Randomization to end of study
    Safety Issue?: No
• To assess the long-term impact of IM olanzapine depot on quality of life in patients diagnosed with schizophrenia or schizoaffective disorder, as measured by the Heinrichs-Carpenter Quality of Life Scale (QLS).
  • Time Frame: Randomization to end of study
    Safety Issue?: No
• To assess the long-term impact of IM olanzapine depot on quality of life in patients diagnosed with schizophrenia or schizoaffective disorder, as measured by the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36).
  • Time Frame: Randomization to end of study
    Safety Issue?: No
• To assess the long-term impact of IM olanzapine depot on quality of life in patients diagnosed with schizophrenia or schizoaffective disorder, as measured by the Resource Utilization Scale.
  • Time Frame: Randomization to end of study
    Safety Issue?: No
• To assess the long-term impact of IM olanzapine depot on quality of life in patients diagnosed with schizophrenia or schizoaffective disorder, as measured by the Hospitalization Inventory Scale.
  • Time Frame: Randomization to end of study
    Safety Issue?: No
• To assess the long-term impact of IM olanzapine depot on quality of life in patients diagnosed with schizophrenia or schizoaffective disorder, as measured by the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S).
  • Time Frame: Randomization to end of study
    Safety Issue?: No
• To assess the long-term impact of IM olanzapine depot on quality of life in patients diagnosed with schizophrenia or schizoaffective disorder, as measured by the Patient Satisfaction with Medication Questionnaire-Modified.
  • Time Frame: At quarterly visits, 6-month visits and Summary.
    Safety Issue?: No
• To determine the blood levels of IM olanzapine depot in patients during long-term treatment.
  • Time Frame: At quarterly visits, 6-month visits and Summary.
    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 Sponsor: Eli Lilly and Company

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 July 02, 2009

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