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Ziprasidone Versus Olanzapine In The Treatment Of Schizophrenia.

Last updated on May 12, 2018

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Study Location
Pfizer Investigational Site
Bilbao, Vizcaya, Spain
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patients at immediate risk of committing harm to self or others

- Concurrent treatment with antipsychotic agents after randomization.

NCT00239109
Pfizer
Completed
Ziprasidone Versus Olanzapine In The Treatment Of Schizophrenia.

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Ziprasidone Versus Olanzapine In The Treatment Of Schizophrenia.
Ziprasidone Versus Olanzapine In The Treatment Of Schizophrenia: A Six Months, Double Blind Randomized, Parallel Group Study.
  • 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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Schizophrenia
  • Drug: Ziprasidone
  • Drug: Olanzapine
  • Procedure: Scales
  • Procedure: measures of the body (Weight...)
  • Procedure: Serum analysis
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
February 2007
Not Provided

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT00239109
A1281064
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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