Olanzapine Pamoate Depot Versus Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia

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.

Intervention(s) in this Clinical Trial

• Drug: olanzapine
  • 10 milligrams (mg), oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
• Drug: olanzapine pamoate depot
  • 405 milligrams (mg), intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Olanzapine Pamoate Depot
  • Olanzapine pamoate depot
• Active Comparator: Olanzapine
  • Oral olanzapine

Primary Measures

• Median Time to Discontinuation for Any Reason (Excluding Sponsor Decision)
  • Time Frame: Baseline up to 104 weeks
    Safety Issue?: No

Secondary Measures

• Change From Baseline in Heinrich-Carpenter Quality of Life in Schizophrenia Scale (QLS) Total Score at 104 Weeks
  • Time Frame: Baseline, 104 weeks
    Safety Issue?: No
• Change From Baseline in 36-Item Short Form Health Survey (SF-36) at 104 Weeks, All Domains and Summary Scores
  • Time Frame: Baseline, 104 weeks
    Safety Issue?: No
• Change From Baseline in Overall Health Status Assessment Using the EuroQol: 5 Dimensions Questionnaire (EQ-5D) at 104 Weeks
  • Time Frame: Baseline, 104 weeks
    Safety Issue?: No
• Change From Baseline in Burden Assessment Scale (BAS) Total Score at 104 Weeks
  • Time Frame: Baseline, 104 weeks
    Safety Issue?: No
• Resource Utilization: Number of Outpatient Physician Visits During the Study
  • Time Frame: Baseline through 104 weeks
    Safety Issue?: No
• Resource Utilization: Days of Unpaid Care, Days of Workdays Missed, Days of Paid Care Per Week During the Study
  • Time Frame: Baseline through 104 weeks
    Safety Issue?: No
• Number of Hospitalization Days
  • Time Frame: Baseline through 104 weeks
    Safety Issue?: No
• Change From Baseline in Scale to Assess Unawareness of Mental Disorder (SUMD) Total Score at 104 Weeks
  • Time Frame: Baseline, 104 weeks
    Safety Issue?: No
• Change From Baseline in Working Alliance Inventory (WAI) Total Score at 104 Weeks
  • Time Frame: Baseline, 104 weeks
    Safety Issue?: No
• Change From Baseline in Schizophrenia Objective Functioning Instrument (SOFI) Global Score at 104 Weeks
  • Time Frame: Baseline, 104 weeks
    Safety Issue?: No
• Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at 104 Weeks (All Items)
  • Time Frame: 104 weeks
    Safety Issue?: No
• Patient Attitude Toward Treatment Using the Drug Attitude Inventory (DAI) Scale Total Score at 104 Weeks
  • Time Frame: 104 weeks
    Safety Issue?: No
• Number of Participants With All-Cause Discontinuations (Excluding Sponsor Decision)
  • Time Frame: Baseline through 104 weeks
    Safety Issue?: No
• Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Scores at 104 Weeks
  • Time Frame: Baseline, 104 weeks
    Safety Issue?: No
• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total and Subscale Scores at 104 Weeks
  • Time Frame: Baseline, 104 weeks
    Safety Issue?: No
• Median Time to Relapse
  • Time Frame: Baseline to time of relapse (up to 104 weeks)
    Safety Issue?: No
• Number of Participants Experiencing Relapse
  • Time Frame: Baseline through 104 weeks
    Safety Issue?: No
• Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Score at 104 Weeks
  • Time Frame: Baseline, 104 weeks
    Safety Issue?: No
• Resource Utilization: Number of Outpatient Surgeries During the Study, 24 Months After Randomization
  • Time Frame: Baseline through 104 Weeks
    Safety Issue?: No
• Change From Baseline in Weight at 104 Weeks
  • Time Frame: Baseline, 104 weeks
    Safety Issue?: Yes
• Participants With Potentially Clinically Significant (PCS) Weight Gain at 104 Weeks
  • Time Frame: Baseline, 104 weeks
    Safety Issue?: Yes
• Participants With Normal to High Fasting Glucose, Fasting Total Cholesterol, and Fasting Triglycerides
  • Time Frame: Baseline through 104 weeks
    Safety Issue?: Yes
• Participants With Treatment-Emergent Abnormal High Prolactin at 104 Weeks
  • Time Frame: Baseline, 104 weeks
    Safety Issue?: Yes
• Participants With Treatment-Emergent High Alanine Transaminase (ALT), Aspartate Transaminase (AST), and Total Bilirubin
  • Time Frame: Baseline through 104 Weeks
    Safety Issue?: Yes
• Participants Discontinuing Because of an Adverse Event (AE) or Death
  • Time Frame: Baseline through 104 weeks
    Safety Issue?: Yes

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 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/NCT00320489

Study ID Number: 6390

ClinicalTrials.gov Identifier: NCT00320489

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry