Official Title: “PREFERENCE: 12-Week Open Label Trial On Olanzapine Orodispersible Tablet Vs. Oral Olanzapine Preference Study”

The purpose of the study is to estimate drug preference of stable schizophrenic patients who will be treated with olanzapine orodispersible tablets for 6 weeks then with olanzapine tablets for 6 weeks and vice-versa.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: September 2007

Intervention(s) in this Clinical Trial

• Drug: olanzapine therapy

Primary Measures

• Patient preference measured by a simple preference question.

Secondary Measures

• Better treatment adherence as measured by DAI-10
• Safety and tolerability as measured by AMDP-5
• Determine the predictors of drug compliance
• Mean change from baseline to endpoint in body mass index (BMI)
• Compare serum ghrelin levels
• Differences in subjective appetite from baseline to endpoint using a visual analog scale (VAS)
• Effect on the medication compliance, level of medication supervision, and willingness to remain on medication, as measured by Medication Adherence Form (MAF)
• Patient preference of the paranoid sub population as measured by a simple preference question

Inclusion Criteria:

• You are an outpatient diagnosed with stable schizophrenia.
• You are a male or female in the age of 18 to 65 years old.
• You are retrospectively judged by investigators, based on clinical interview and impression, to have been stable for at least 4 weeks.
• You must be able to take olanzapine orodispersible in a single daily dose.
• You are treated with conventional oral olanzapine tablet (as monotherapy) for at least 1 month.

Exclusion Criteria:

• You have used olanzapine in the past and are no longer using it because of a bad reaction.
• You have known Human immunodeficiency virus positive (HIV+) status.
• You have known uncorrected, narrow angle glaucoma.
• You have known Leukopenia, (abnormally low white blood cell count).
• You have a serious or uncontrolled illness (for example: liver disease, history of heart disease, or inadequately controlled diabetes.)
• You have Parkinson's disease.
• You are a female patient who is either pregnant or nursing
• You are taking medications that are not allowed in the study.

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 September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00324051

Study ID Number: 10960

ClinicalTrials.gov Identifier: NCT00324051

Health Authority: Israel: Ethics Commission

Lilly Clinical Trial Registry