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An Observational Study of Olanzapine Coated and Orodispersible Tablets Effectiveness in Schizophrenic and Bipolar Outpatients.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00510211
First Posted: August 1, 2007
Last Update Posted: August 3, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eli Lilly and Company
  Purpose
The primary objective of this study is to assess the proportion of schizophrenic patients and the proportion of bipolar patients who discontinue olanzapine within 12 months of treatment in outpatient, ambulatory or community settings

Condition Intervention
Schizophrenia Bipolar Disorder Drug: olanzapine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of Olanzapine Coated and Orodispersible Tablets Effectiveness in Schizophrenic and Bipolar Outpatients.

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Enrollment: 1131
Study Start Date: April 2007
Study Completion Date: May 2009
Groups/Cohorts Assigned Interventions
olanzapine coated tablet Drug: olanzapine
olanzapine orodispersable tablet Drug: olanzapine

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients observed in outpatient settings (ambulatory and community)
Criteria

Inclusion Criteria:

  • patients suffering from schizophrenic or schizoaffective disorders based on the disease diagnostic criteria DSM IV and being prescribed olanzapine during the 45 preceding days.
  • patients suffering from bipolar disorders based on the disease diagnostic criteria DSM IV and being prescribed olanzapine during the 45 preceding days for one of the following:
  • moderate or severe manic episode
  • relapse prevention in patients with bipolar disorder

Exclusion Criteria:

  • current treatment with any investigational drug or procedure at entry or during the whole study
  • hypersensitivity to olanzapine
  • patients with known narrow angle glaucoma risk
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00510211


Locations
France
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.
Paris, France, 75674
Germany
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.
Bad Homburg, Germany, D-61350
Greece
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.
Thessaloniki, Greece, 54630
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-615-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00510211     History of Changes
Other Study ID Numbers: 11610
F1D-FR-B035
First Submitted: July 30, 2007
First Posted: August 1, 2007
Last Update Posted: August 3, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Schizophrenia
Bipolar Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents