Patient's Preference Between Conventional Oral Olanzapine Tablet vs Olanzapine Orodispersible Tablet

Condition(s) targeted: Schizophrenia

Intervention: olanzapine therapy (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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, Affiliation: Eli Lilly and Company

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.

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

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

Primary outcome: Patient preference measured by a simple preference question.

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Rio De Janeiro 21020-130, Brazil

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Constanta, Romania

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Adana, Turkey

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Ankara, Turkey

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Bursa 16045, Turkey

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Elazig 23800, Turkey

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Gaziantep, Turkey

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Istanbul 34390, Turkey

Lilly Clinical Trial Registry

Starting date: May 2006
Ending date: September 2007
Last updated: January 21, 2008