Ziprasidone Versus Olanzapine In The Treatment Of Schizophrenia.
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      -  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
    


Intervention name(s): Ziprasidone; Olanzapine; Scales; measures of the body (Weight...); Serum analysis
Intervention type(s): Drug; Drug; Procedure; Procedure; Procedure
Intervention MeSH terms: Olanzapine; Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment