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

NCT00510211 | Completed

• 2 other identifiers: 11610F1D-FR-B035
• Study Type: observational
• Target: 1,131
• Locations: 3 countries
• Sites: 3

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

Conditions

Schizophrenia; Bipolar Disorder

Study Arms (2)

olanzapine coated tablet

Drug: olanzapine

olanzapine orodispersable tablet

Drug: olanzapine

Interventions

olanzapine DRUG

olanzapine coated tablet; olanzapine orodispersable tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients observed in outpatient settings (ambulatory and community)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

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, 75674, France

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.

Bad Homburg, D-61350, Germany

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.

Thessaloniki, 54630, Greece

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 30, 2007
• First Posted: August 1, 2007
• Study Start: April 1, 2007
• Study Completion: May 1, 2009
• Last Updated: August 3, 2009

Record last verified: 2009-07

Locations

FR (1); DE (1); GR (1)