Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2009

Intervention(s) in this Clinical Trial

• Drug: olanzapine pamoate depot
  • 405mg, intramuscular injection, followed 4 weeks later by 150-405mg flexible dosing, intramuscular injection, every 4 weeks for 96 weeks.
• Drug: olanzapine
  • 10mg, oral tablets, once daily for 4 weeks followed by 5-20mg flexible dosing, oral tablets, once daily, for 100 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Olanzapine pamoate depot
• Active Comparator: B
  • Oral olanzapine

Primary Measures

• To assess the difference between olanzapine pamoate depot and oral olanzapine on time to all-cause discontinuation in outpatients with schizophrenia who are at risk for relapse.
  • Time Frame: 104 weeks
    Safety Issue?: No

Secondary Measures

• To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on health outcomes measures using the Heinrich-Carpenter Quality of Life in Schizophrenia Scale (QLS).
  • Time Frame: 104 weeks
    Safety Issue?: No
• To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on health outcomes measures using the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36).
  • Time Frame: 104 weeks
    Safety Issue?: No
• To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on health outcomes measures using the EuroQol: 5 Dimensions Questionnaire (EQ-5D).
  • Time Frame: 104 weeks
    Safety Issue?: No
• To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on health outcomes measures using the Burden Assessment Scale (BAS).
  • Time Frame: 104 weeks
    Safety Issue?: No
• To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on health outcomes measures using the Resource Utilization Scale.
  • Time Frame: 104 weeks
    Safety Issue?: No
• To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on health outcomes measures using the Hospitalization Inventory Scale.
  • Time Frame: 104 weeks
    Safety Issue?: No
• To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on health outcomes measures using the Scale to Assess Unawareness of Mental Disorder (SUMD).
  • Time Frame: 104 weeks
    Safety Issue?: No
• To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on health outcomes measures using the Working Alliance Inventory (WAI).
  • Time Frame: 104 weeks
    Safety Issue?: No
• To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on health outcomes measures using the Schizophrenia Objective Functioning Instrument (SOFI).
  • Time Frame: 104 weeks
    Safety Issue?: No
• To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on patient satisfaction of treatment using the Patient Satisfaction with Medication Questionnaire-Modified (PMSQ).
  • Time Frame: 104 weeks
    Safety Issue?: No
• To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on patient satisfaction of treatment using the Drug Attitude Inventory (DAI) scale.
  • Time Frame: 104 weeks
    Safety Issue?: No
• To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on the incidence of all-cause discontinuations.
  • Time Frame: 104 weeks
    Safety Issue?: No
• To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on the time to relapse.
  • Time Frame: 104 weeks
    Safety Issue?: No
• To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on the incidence of patients experiencing relapse.
  • Time Frame: 104 weeks
    Safety Issue?: No
• To assess the difference(s) in efficacy between olanzapine pamoate depot and oral olanzapine on the change from baseline to endpoint in the Clinical Global Impression - Severity of Illness (CGI-S) Scale scores.
  • Time Frame: 104 weeks
    Safety Issue?: No
• To assess the difference(s) in efficacy between olanzapine pamoate depot and oral olanzapine on the Positive and Negative Syndrome Scale (PANSS) total and subscale scores including the Brief Psychiatric Rating Scale (BPRS).
  • Time Frame: 104 weeks
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 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 October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00320489

Study ID Number: 6390

ClinicalTrials.gov Identifier: NCT00320489

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry