Comparison of Continuing Olanzapine to Switching to Quetiapine in Overweight or Obese Patients With Schizophrenia and Schizoaffective Disorder - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00090012

Purpose

The purposes of this study are to determine:

The effectiveness of olanzapine as compared to quetiapine in treating and preventing the recurrence of a variety of symptoms of schizophrenia and schizoaffective disorder in patients who are obese or overweight.
The safety of olanzapine as compared to quetiapine.

Condition	Intervention	Phase
Schizophrenia Schizoaffective Disorder	Drug: Olanzapine Drug: Quetiapine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Comparison of Efficacy and Safety of Continuing Olanzapine to Switching to Quetiapine in Overweight or Obese Patients With Schizophrenia and Schizoaffective Disorder

Resource links provided by NLM:

MedlinePlus related topics: Obesity Schizophrenia

Drug Information available for: Quetiapine Quetiapine fumarate Olanzapine

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

The primary objective of this study is to assess the treatment difference in time to relapse while on olanzapine 7.5-20 mg/day versus quetiapine 300-800 mg/day in the treatment of obese or overweight patients
with schizophrenia or schizoaffective disorder. Relapse is defined as the occurrence of at least one of the following three conditions:
Hospitalization for psychiatric reasons after Visit 2, or
20% worsening on the Positive and Negative Syndrome Sale (PANSS) Total and an increase in level of care, as compared to Visit 2, or
20% worsening on the PANSS Total compared to Visit 2 and worsening of CGI-S by at least one level compared to Visit 2 and CGI-S level of at least 4 (moderately ill).

Secondary Outcome Measures:

To assess within and between group changes in metabolic parameters including fasting glucose, hemoglobin Alc, lipids, and insulin
To assess within and between group changes in weight, waist circumference, BMI, appetite, and prevalence of patients meeting criteria for the metabolic syndrome
To assess within and between group changes in metabolic parameters (fasting glucose and lipids, and hemoglobin A1c) in a sub-group of patients with pre-existing diabetes prior to study entry
To assess the effect of olanzapine versus quetiapine on time to discontinuation for any reason, or lack of efficacy or worsening of psychiatric syndromes
To assess the efficacy of olanzapine versus quetiapine in improving psychopathology of schizophrenia as measured by a mean change from baseline on the PANSS and the Clinical Global Impression-Severity (CGI-S)
Scale as well as by absolute score of CGI-I (Improvement Scale)
To assess the efficacy of olanzapine versus quetiapine in improving depressive symptoms as measured by a mean change from baseline on the montgomery-Asberg Depression Rating Scale (MADRS)
To assess the efficacy of olanzapine versus quetiapine in improving patients' general well being and overall level of functioning as measured by the Short Form 36 Health Survey (SF-36), the Patient Global Impression (PGI)Scale,
and the Global Assessment of Functioning (GAF) Scale
To assess patients' opinions on the treatment with olanzapine versus quetiapine as measured by the Drug Attitude Inventory (DAI-10) Scale
To compare the utilization of medical resources between patients treated with olanzapine or quetiapine
To assess the safety of olanzapine and quetiapine as determined by:
Treatment-emergent adverse events
Vital signs and fasting laboratory analytes
Extrapyramidal symptoms as measured by the Modified Simpson-Angus Scale, the Barnes Akathisia Rating Scale, and the Abnormal Involuntary Movement Scale (AIMS)
A sensitivity analysis will be performed on two randomly chosen subsamples of the overall patient population by analyzing the primary objective respectively

Estimated Enrollment:	340
Study Start Date:	July 2004
Study Completion Date:	March 2006

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

You must be 18-75 years of age and be diagnosed with schizophrenia or schizoaffective disorder
You must be able to visit the doctor's office thirteen (13) times over a twenty-six (26) week period

Exclusion Criteria:

You are a woman and are pregnant or breastfeeding
You have an acute or unstable medical illness, such as heart, liver, or kidney disease, or you have a seizure disorder. (Note: If you are uncertain about a particular condition, please discuss it with your physician.)
You have a history of allergic reaction or intolerance to olanzapine or quetiapine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090012

Show 25 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call1-877-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

Study ID Numbers:	8894, F1D-US-HGLR
Study First Received:	August 18, 2004
Last Updated:	November 5, 2007
ClinicalTrials.gov Identifier:	NCT00090012 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Olanzapine
Psychotropic Drugs
Antiemetics
Overweight
Body Weight
Schizophrenia
Signs and Symptoms
Pathologic Processes
Mental Disorders
Therapeutic Uses

Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Tranquilizing Agents
Disease
Gastrointestinal Agents
Central Nervous System Depressants
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Quetiapine
Serotonin Agents
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010