Overview

Olanzapine Pamoate Depot Versus Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia

Status:
Completed
Trial end date:
2009-09-01
Target enrollment:
0
Participant gender:
All
Summary
To compare the health outcome of patients with schizophrenia, who are at risk for relapse, when treated with a long acting injection form of olanzapine versus treatment with oral olanzapine.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Olanzapine
Criteria
Inclusion Criteria:

- Clinical diagnosis of schizophrenia

- Must be an outpatient (not requiring hospitalization) now and for at least the past 8
weeks.

- Disease symptoms must meet a certain range as assessed by the clinician.

- Patient has experienced at least two episodes of clinical worsening of their
condition. This could mean admission to a hospital or an emergency room visit. This
could mean that a new medication was added, medication dose was increased, or
medication was switched in order to better control symptoms of the condition.

- The patient must have an unsatisfactory response to their current medication or be
experiencing negative effects of their current medication or not always take their
current medication so that a change in current medication is desired.

Exclusion Criteria:

- Patients who are actively suicidal.

- Patients who are pregnant or nursing.

- Patients who have stopped past treatment with olanzapine because of adverse events,
are treatment resistant or allergic to olanzapine, or have a condition which would
prevent use of a long acting form of olanzapine.

- Patients with uncorrected narrow-angle glaucoma, seizures, uncontrolled diabetes,
certain diseases of the liver, uncontrolled thyroid condition or other serious or
unstable illness.

- Patients with Parkinson's disease, psychosis related to dementia or other related
disorders.