Safety and Efficacy of Aripiprazole and Ziprasidone Among Schizophrenic Patients With Metabolic Syndrome
Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
Participant gender:
Summary
Introduction:
Schizophrenia is a serious mental illness. For majority of patients it is a lifetime
condition,characterized by intermittent episodes of hospitalization due to relapse or acute
symptom exacerbation. The nature and course of the disorder impose significant social and
economic burden. Relapse is costly, with hospitalization accounting for a substantial portion
of healthcare expenses. Second generation antipsychotic side effect such as metabolic
syndrome and diabetes mellitus will contribute additional costs to the treatment.
Many studies have since then provided convincing evidence for a high risk of diabetes and
other glucose abnormalities, metabolic syndrome and mortality due to elevated cardiovascular
risk in patients with schizophrenia.
However many studies has shown the effectiveness and safety of aripiprazole and
ziprazidone.In one of the study, aripiprazole showed improvement of negative schizophrenic
symptoms by 25% and 50% of functioning level from baseline. In term of safety, antipsychotics
considered to have a safer metabolic profile were amisulpride, ziprasidone and aripiprazole.
Study objectives:
- To investigate the safety and efficacy of ziprazidone versus aripiprazole in the
treatment of schizophrenia patients with metabolic syndrome and diabetes mellitus.
- To investigate the reversibility of metabolic syndrome and diabetes parameters following
the treatment with ziprazidone versus aripiprazole.
Hypotheses:
* The proportion of reversibility of metabolic syndrome and diabetes parameters is higher
following the treatment of ziprazidone than aripiprazole.