Olanzapine Pamoate Depot Versus Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00320489

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: olanzapine pamoate depot Drug: olanzapine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open-label Study Comparing the Effects of Olanzapine Pamoate Depot With Oral Olanzapine on Treatment Outcomes in Outpatients With Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Olanzapine

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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. [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on health outcomes measures using the Heinrich-Carpenter Quality of Life in Schizophrenia Scale (QLS). [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on health outcomes measures using the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on health outcomes measures using the EuroQol: 5 Dimensions Questionnaire (EQ-5D). [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on health outcomes measures using the Burden Assessment Scale (BAS). [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on health outcomes measures using the Resource Utilization Scale. [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on health outcomes measures using the Hospitalization Inventory Scale. [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on health outcomes measures using the Scale to Assess Unawareness of Mental Disorder (SUMD). [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on health outcomes measures using the Working Alliance Inventory (WAI). [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on health outcomes measures using the Schizophrenia Objective Functioning Instrument (SOFI). [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on patient satisfaction of treatment using the Patient Satisfaction with Medication Questionnaire-Modified (PMSQ). [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on patient satisfaction of treatment using the Drug Attitude Inventory (DAI) scale. [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on the incidence of all-cause discontinuations. [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on the time to relapse. [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
To assess the difference(s) between olanzapine pamoate depot and oral olanzapine on the incidence of patients experiencing relapse. [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
To assess the difference(s) in efficacy between olanzapine pamoate depot and oral olanzapine on the change from baseline to endpoint in the Clinical Global Impression - Severity of Illness (CGI-S) Scale scores. [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
To assess the difference(s) in efficacy between olanzapine pamoate depot and oral olanzapine on the Positive and Negative Syndrome Scale (PANSS) total and subscale scores including the Brief Psychiatric Rating Scale (BPRS). [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]

Enrollment:	504
Study Start Date:	April 2006
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Olanzapine pamoate depot	Drug: olanzapine pamoate depot 405mg, intramuscular injection, followed 4 weeks later by 150-405mg flexible dosing, intramuscular injection, every 4 weeks for 96 weeks.
B: Active Comparator Oral olanzapine	Drug: olanzapine 10mg, oral tablets, once daily for 4 weeks followed by 5-20mg flexible dosing, oral tablets, once daily, for 100 weeks.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320489

Show 49 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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)

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:	6390, F1D-MC-HGLQ
Study First Received:	April 28, 2006
Last Updated:	October 29, 2009
ClinicalTrials.gov Identifier:	NCT00320489 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on February 08, 2010