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

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ClinicalTrials.gov Identifier: NCT00510211
Recruitment Status : Completed
First Posted : August 1, 2007
Last Update Posted : August 3, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

Brief Summary:
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 or disease Intervention/treatment
Schizophrenia Bipolar Disorder Drug: olanzapine

Study Type : Observational
Actual Enrollment : 1131 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study of Olanzapine Coated and Orodispersible Tablets Effectiveness in Schizophrenic and Bipolar Outpatients.
Study Start Date : April 2007
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
olanzapine coated tablet Drug: olanzapine
olanzapine orodispersable tablet Drug: olanzapine




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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 Posted: August 1, 2007    Key Record Dates
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