Ziprasidone Versus Olanzapine In The Treatment Of Schizophrenia.
Status:
Completed
Trial end date:
2007-02-01
Target enrollment:
Participant gender:
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
Phase:
Phase 4
Details
Lead Sponsor:
Pfizer Pfizer's Upjohn has merged with Mylan to form Viatris Inc.