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NCT00510211 Clinical Trial

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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00510211
Other study ID # 11610
Secondary ID F1D-FR-B035
Status Completed
Phase N/A
First received July 30, 2007
Last updated July 31, 2009
Start date April 2007
Est. completion date May 2009

Study information
Verified date July 2009
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority France: French Data Protection AuthorityGreece: National Organization of MedicinesGermany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 1131
Est. completion date May 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• olanzapine

Locations
Country Name City State
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
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
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

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

France,  Germany,  Greece, 

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