Ziprasidone Versus Olanzapine In The Treatment Of Schizophrenia. - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00239109

Purpose

Various studies suggest that patients treated with Olanzapine can experience a substantial weight gain, while no changes have been observed in patients treated with Ziprasidone. Negative consequences on lipid and glucose profiles have also been observed in patients treated with Olanzapine. Most of the available data belong to short-term studies. However, for most clinical trials the primary variable was an efficacy variable, and included the weight assessment as a secondary variable; they also lack a systematic monitoring of some variables that can play a role in weight gain, as the level of exercise, appetite increase, etc. and we have considered of importance their inclusion in this protocol. Previous studies did not assess visceral fat using widely standardized parameters as the waist index, which at certain levels is considered an indicator of the cardiovascular risk, or leptine, highly correlated to the body fat storage. We would like to fit the recently published American Diabetes Association, American Psychiatric Association, American Association of Clinical Endocrinologists and North American Association for the Study of Obesity Antipsychotic, obesity and diabetes mellitus consensus.22
Schizophrenic patients show a 4-fold probability to die as a consequence of cardiovascular problems compared to the normal population. The antipsychotic treatment can contribute to increase this risk favoring weight gain and the appearance of cardiovascular risk factors associated to obesity (blood hypertension, hyperlipidemia, type II Diabetes Mellitus). We intend to obtain a complete cardiovascular risk profile of patients, as well as its change during antipsychotic treatment, including primary cardiovascular risk factors in addition to the analysis of markers that have recently been linked to cardiovascular risk (as reactive protein C).
The study will evaluate the risk of hyperglycemia, insulin resistance and Diabetes Mellitus, and will investigate the association between glucose homeostasis abnormalities and weight gain in the treated patients. Likewise, adiponectine, secreted from adipocytes and a possible link between obesity and insulin resistance will be determined; recent studies show an adiponectine decrease in humans with insulin resistance and obesity; furthermore, prospective studies have shown these changes could predict a higher risk of DM development.
Changes have been introduced in the complete evaluation of the patient's metabolic and cardiovascular profiles with the advice, and under the coordination of endocrinologists after a complete review of the subject

Condition	Intervention	Phase
Schizophrenia	Drug: Ziprasidone Drug: Olanzapine Procedure: Scales Procedure: measures of the body (Weight...) Procedure: Serum analysis	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Ziprasidone Versus Olanzapine In The Treatment Of Schizophrenia: A Six Months, Double Blind Randomized, Parallel Group Study.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines Obesity Schizophrenia

Drug Information available for: Ziprasidone hydrochloride Olanzapine Ziprasidone Ziprasidone mesylate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

To estimate and compare the effects of ziprasidone vs olanzapine on body weight in the treatment of patients with schizophrenia.

Secondary Outcome Measures:

PANSS total score; change from baseline CGI severity; change from baseline CGI - Improvement PANSS negative subscale score; change from baseline DSM IV axis V Patient preference scale (PPS) Heath Utility Index Mark III BMI , Qaist Index

Estimated Enrollment:	112
Study Start Date:	April 2003
Estimated Study Completion Date:	February 2007

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with a primary diagnosis of schizophrenia using the DSM-IV-TR criteria
Patient's clinical condition should justify treatment initiation with a new antipsychotic drug.

Exclusion Criteria:

Patients at immediate risk of committing harm to self or others
Concurrent treatment with antipsychotic agents after randomization.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239109

Locations

Spain
Pfizer Investigational Site
Bilbao, Vizcaya, Spain
Pfizer Investigational Site
Badajoz, Spain
Pfizer Investigational Site
Barcelona, Spain
Pfizer Investigational Site
Madrid, Spain
Pfizer Investigational Site
Salamanca, Spain
Pfizer Investigational Site
Sevilla, Spain
Pfizer Investigational Site
Zamora, Spain

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00239109 History of Changes
Other Study ID Numbers:	A1281064
Study First Received:	October 12, 2005
Last Updated:	March 17, 2008
Health Authority:	Spain: Ministry of Health and Consumption

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Olanzapine
Ziprasidone
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Antagonists
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on February 07, 2012