Schizophrenia
Conditions
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.
Interventions
DRUGolanzapine therapy
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient preference measured by a simple preference question. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
| Better treatment adherence as measured by DAI-10 | — |
| 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 | — |
| Compare serum ghrelin levels | — |
Countries
Brazil, Romania, Turkey (Türkiye)
Outcome results
None listed