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Clinical Trials/NCT00937755
NCT00937755
Completed
Not Applicable

The Study of Atypical Antipsychotics-induced Metabolic Disturbances

Taipei Medical University Hospital1 site in 1 country80 target enrollmentMarch 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
Taipei Medical University Hospital
Enrollment
80
Locations
1
Primary Endpoint
glucose homeostasis
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

Schizophrenia is one of the most severe mental illnesses. The antipsychotic drugs, introduced in early 1950s, have revolutionized the treatment of schizophrenia. About 2 to 4 times as many patients relapse when treated with a placebo as do those treated with antipsychotic drugs. For these medications to be maximally beneficial, they must have an acceptable side effect profile and be taken as prescribed. One untoward effect of many antipsychotic drugs is weight gain. The extent of weight gain apparently varies by drug, which may be because of drugs'differing degrees of action on serotonergic, dopaminergic, histaminergic, and other neurotransmitter systems. Obesity is a threat to health and longevity. Weight gain may also cause patients taking antipsychotic medication to discontinue their medication, which may predispose them to relapse.

The pattern of weight gain and metabolic disturbance may vary between the different antipsychotic agents. The underlying mechanism and treatment of these adverse metabolic effects remain unclear. This study will recruit 60 schizophrenic patients during. The patients received monotherapy with atypical antipsychotics (olanzapine, quetiapine, or risperidone). The assessment of metabolic profile will be monitored at baseline, week 2, week 4, and week 8. The measurements include anthropometrical parameters, body composition, glucose level, insulin level, lipid profile, and leptin level. Intra-venous glucose tolerance test will be used to assess the insulin secretion and insulin sensitivity.

This proposal broadly aims to discover the underlying mechanism of antipsychotics induced metabolic disturbance and develop efficient treatment to correct it.

Registry
clinicaltrials.gov
Start Date
March 2006
End Date
May 2009
Last Updated
16 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • clinical diagnosis of schizophrenia
  • age 18-60 years

Exclusion Criteria

  • received any SGAs prior to this study
  • medical conditions that may confound glucoregulatory assessment
  • pregnancy

Outcomes

Primary Outcomes

glucose homeostasis

Time Frame: 8 weeks

Secondary Outcomes

  • lipid homeostasis(8 weeks)

Study Sites (1)

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