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

Condition(s) targeted: Schizophrenia

Intervention: olanzapine pamoate depot (Drug); olanzapine (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT- 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company

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.

Official title: A Randomized, Open-Label Study Comparing the Effects of Olanzapine Pamoate Depot With Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia

Study design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: To assess the difference between olanzapine pamoate depot and oral olanzapine on time to all-cause discontinuation in outpatients with schizophrenia who are at risk for relapse.

Secondary outcome:

To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on health outcome measures

patient satisfaction with treatment

the incidence of all-cause discontinuation

time to relapse

incidence of patient's experiencing relapse

change from baseline to endpoint in efficacy scale scores

safety and tolerability of treatment.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

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., Banfield B1828CKR, Argentina

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., Buenos Aires 1118, Argentina

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Lilly Clinical Trial Registry

Starting date: April 2006
Ending date: June 2009
Last updated: January 9, 2008