Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00088465

Purpose

This is a long-term, open-label clinical study designed to enable longer-term treatment of patients completing other clinical studies with intramuscular olanzapine depot.

Key objectives of the study are to:

Determine how well intramuscular (IM) olanzapine depot works during long-term treatment,
Evaluate the safety and tolerability of IM olanzapine depot during long-term treatment,
Determine the blood levels of IM olanzapine depot in patients during long-term treatment

Condition	Intervention	Phase
Schizophrenic Disorders Schizoaffective Disorder	Drug: Intramuscular olanzapine depot	Phase III

MedlinePlus related topics: Schizophrenia

Drug Information available for: Olanzapine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

To assess the long-term safety of IM olanzapine depot in patients diagnosed with schizophrenia and schizoaffective disorder by monitoring laboratory values, vital signs, electrocardiograms, adverse events, and extrapyramidal symptoms. [ Time Frame: Randomization to end of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess long-term efficacy of IM olanzapine depot in patients diagnosed with schizophrenia or schizoaffective disorder by measuring Positive and Negative Syndrome Scale (PANSS) Total scores. [ Time Frame: Randomization to end of study ] [ Designated as safety issue: No ]
To assess the long-term efficacy of IM olanzapine depot in patients diagnosed with schizophrenia or schizoaffective disorder by measuring the PANSS Positive scores. [ Time Frame: Randomization to end of study ] [ Designated as safety issue: No ]
To assess the long-term efficacy of IM olanzapine depot in patients diagnosed with schizophrenia or schizoaffective disorder by measuring the PANSS Negative scores. [ Time Frame: Randomization to end of study ] [ Designated as safety issue: No ]
To assess the long-term efficacy of IM olanzapine depot in patients diagnosed with schizophrenia or schizoaffective disorder by measuring the PANSS General Psychopathology Subscales. [ Time Frame: Randomization to end of study ] [ Designated as safety issue: No ]
To assess the long-term efficacy of IM olanzapine depot in patients diagnosed with schizophrenia or schizoaffective disorder by measuring Clinical Global Impression-Severity of Illness (CGI-S) scores. [ Time Frame: Randomization to end of study ] [ Designated as safety issue: No ]
To assess the long-term impact of IM olanzapine depot on quality of life in patients diagnosed with schizophrenia or schizoaffective disorder, as measured by the Heinrichs-Carpenter Quality of Life Scale (QLS). [ Time Frame: Randomization to end of study ] [ Designated as safety issue: No ]
To assess the long-term impact of IM olanzapine depot on quality of life in patients diagnosed with schizophrenia or schizoaffective disorder, as measured by the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). [ Time Frame: Randomization to end of study ] [ Designated as safety issue: No ]
To assess the long-term impact of IM olanzapine depot on quality of life in patients diagnosed with schizophrenia or schizoaffective disorder, as measured by the Resource Utilization Scale. [ Time Frame: Randomization to end of study ] [ Designated as safety issue: No ]
To assess the long-term impact of IM olanzapine depot on quality of life in patients diagnosed with schizophrenia or schizoaffective disorder, as measured by the Hospitalization Inventory Scale. [ Time Frame: Randomization to end of study ] [ Designated as safety issue: No ]
To assess the long-term impact of IM olanzapine depot on quality of life in patients diagnosed with schizophrenia or schizoaffective disorder, as measured by the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S). [ Time Frame: Randomization to end of study ] [ Designated as safety issue: No ]
To assess the long-term impact of IM olanzapine depot on quality of life in patients diagnosed with schizophrenia or schizoaffective disorder, as measured by the Patient Satisfaction with Medication Questionnaire-Modified. [ Time Frame: At quarterly visits, 6-month visits and Summary. ] [ Designated as safety issue: No ]
To determine the blood levels of IM olanzapine depot in patients during long-term treatment. [ Time Frame: At quarterly visits, 6-month visits and Summary. ] [ Designated as safety issue: Yes ]

Enrollment:	923
Study Start Date:	August 2004
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental IM olanzapine depot flexible dosing and flexible interval	Drug: Intramuscular olanzapine depot 45-405mg, intramuscular injection, on a 2-, 3-, or 4-week interval.

Eligibility

Ages Eligible for Study:	18 Years to 76 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have schizophrenia
Female patients of childbearing potential must be using a medically accepted means of contraception
Patients must have completed (within 10 days) another IM olanzapine depot study if permitted by that study's protocol.

Exclusion Criteria:

Patients must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to study entry
Female patients must not be pregnant or breast-feeding
Patients must not be experiencing acute, serious or unstable medical conditions other than schizophrenia or schizoaffective disorder
Patients must not have a substance (except nicotine or caffeine) dependence within the past 30 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00088465

Show 92 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

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	5995, F1D-MC-HGKB
Study First Received:	July 26, 2004
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00088465
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Olanzapine

Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

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

Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009