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

Lilly

Status: Completed

Conditions: Schizophrenia; Bipolar Disorder

Treatments: Drug: olanzapine

Study type: Observational

Funder types: Industry

Identifiers

NCT00510211

F1D-FR-B035

11610 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 1,131 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,131 participants in 2 patient groups

olanzapine coated tablet

Treatment:

Drug: olanzapine

olanzapine orodispersable tablet

Treatment:

Drug: olanzapine