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Ziprasidone Versus Olanzapine In The Treatment Of Schizophrenia.
This study has been completed.
First Received: October 12, 2005   Last Updated: March 17, 2008   History of Changes
Sponsored by: 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: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study
Official Title: Ziprasidone Versus Olanzapine In The Treatment Of Schizophrenia: A Six Months, Double Blind Randomized, Parallel Group Study.

Resource links provided by NLM:


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
BADAJOZ, Spain
Pfizer Investigational Site
BARCELONA, Spain
Pfizer Investigational Site
MADRID, Spain
Pfizer Investigational Site
SEVILLA, Spain
Pfizer Investigational Site
Salamanca, Spain
Pfizer Investigational Site
Zamora, Spain
Spain, VIZCAYA
Pfizer Investigational Site
BILBAO, VIZCAYA, Spain
Spain, Vizcaya
Pfizer Investigational Site
Bilbao, Vizcaya, Spain
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

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

Study placed in the following topic categories:
Neurotransmitter Agents
Tranquilizing Agents
Olanzapine
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Antipsychotic Agents
Serotonin Uptake Inhibitors
Serotonin
Schizophrenia
Dopamine
Mental Disorders
Dopamine Agents
Psychotic Disorders
Peripheral Nervous System Agents
Ziprasidone
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Olanzapine
Antiemetics
Schizophrenia
Serotonin Antagonists
Mental Disorders
Therapeutic Uses
Schizophrenia and Disorders with Psychotic Features
Tranquilizing Agents
Gastrointestinal Agents
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Dopamine Agents
Peripheral Nervous System Agents
Ziprasidone
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 11, 2009