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

This study is ongoing, but not recruiting participants.

First Received: July 30, 2007 Last Updated: May 13, 2008 History of Changes

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00510211

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
Bipolar Disorder Schizophrenia	Drug: olanzapine

MedlinePlus related topics: Bipolar Disorder Schizophrenia

Drug Information available for: Olanzapine

U.S. FDA Resources

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

Further study details as provided by Eli Lilly and Company:

Estimated Enrollment:	1000
Study Start Date:	April 2007
Estimated Study Completion Date:	June 2009

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	11610, F1D-FR-B035
Study First Received:	July 30, 2007
Last Updated:	May 13, 2008
ClinicalTrials.gov Identifier:	NCT00510211 History of Changes
Health Authority:	France: French Data Protection Authority; Germany: Federal Institute for Drugs and Medical Devices; Greece: National Organization of Medicines

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Bipolar Disorder
Olanzapine
Psychotropic Drugs
Antiemetics
Antipsychotic Agents
Serotonin Uptake Inhibitors

Serotonin
Schizophrenia
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Bipolar Disorder
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Olanzapine
Antiemetics
Central Nervous System Depressants
Antipsychotic Agents

Serotonin Uptake Inhibitors
Pharmacologic Actions
Schizophrenia
Affective Disorders, Psychotic
Serotonin Agents
Autonomic Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Peripheral Nervous System Agents
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on March 16, 2009