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

Eli Lilly and Company284 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

284

Conditions

Schizophrenia

Interventions

olanzapine therapyDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (8)

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, Brazil

Outcomes

Primary Outcomes

Patient preference measured by a simple preference question.

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.