An Observational Study of Olanzapine Coated and Orodispersible Tablets Effectiveness in Schizophrenic and Bipolar Outpatients.
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00510211
First received: July 30, 2007
Last updated: July 31, 2009
Last verified: July 2009
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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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00510211 History of Changes |
| Other Study ID Numbers: | 11610, F1D-FR-B035 |
| Study First Received: | July 30, 2007 |
| Last Updated: | July 31, 2009 |
| Health Authority: | France: French Data Protection Authority Greece: National Organization of Medicines Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Bipolar Disorder Schizophrenia Affective Disorders, Psychotic Mood Disorders Mental Disorders Schizophrenia and Disorders with Psychotic Features Olanzapine Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on June 17, 2013