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Completed

NCT Number: NCT00324051

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

olanzapine therapy

Drug

Primary outcomes

  1. Patient preference measured by a simple preference question.

Secondary outcomes

  1. Better treatment adherence as measured by DAI-10

  2. Safety and tolerability as measured by AMDP-5

  3. Determine the predictors of drug compliance

  4. Mean change from baseline to endpoint in body mass index (BMI)

  5. Compare serum ghrelin levels

  6. Differences in subjective appetite from baseline to endpoint using a visual analog scale (VAS)

  7. Effect on the medication compliance, level of medication supervision, and willingness to remain on medication, as measured by Medication Adherence Form (MAF)

  8. Patient preference of the paranoid sub population as measured by a simple preference question

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Acronym: PREFERENCE

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 10, 2006
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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