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

Study Overview
=================
Brief Summary
-----------------
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

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: olanzapine therapy


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: olanzapine therapy|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient preference measured by a simple preference question. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |