Clinical trial NCT00324051: Patient's Preference Between Conventional Oral Olanzapine Tablet vs Olanzapine Orodispersible Tablet
Official title: PREFERENCE: 12-Week Open Label Trial On Olanzapine Orodispersible Tablet Vs. Oral Olanzapine Preference Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-05-10
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Patient preference measured by a simple preference question.
Secondary outcomes:
measure: Better treatment adherence as measured by DAI-10
measure: Safety and tolerability as measured by AMDP-5
measure: Determine the predictors of drug compliance
measure: Mean change from baseline to endpoint in body mass index (BMI)
measure: Compare serum ghrelin levels
measure: Differences in subjective appetite from baseline to endpoint using a visual analog scale (VAS)
measure: Effect on the medication compliance, level of medication supervision, and willingness to remain on medication, as measured by Medication Adherence Form (MAF)
measure: Patient preference of the paranoid sub population as measured by a simple preference question
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: 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.
city: Constanta
country: Romania
facility: 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.
city: Adana
country: Turkey
facility: 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.
city: Ankara
country: Turkey
facility: 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.
city: Bursa
country: Turkey
facility: 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.
city: Elazig
country: Turkey
facility: 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.
city: Gaziantep
country: Turkey
facility: 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.
city: Istanbul
country: Turkey
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: Bitter I, Treuer T, Dilbaz N, Oyffe I, Ciorabai EM, Gonzalez SL, Ruschel S, Salburg J, Dyachkova Y. Patients' preference for olanzapine orodispersible tablet compared with conventional oral tablet in a multinational, randomized, crossover study. World J Biol Psychiatry. 2010 Oct;11(7):894-903. doi: 10.3109/15622975.2010.505663.