The Study of Atypical Antipsychotics-induced Metabolic Disturbances

Study Overview
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Brief Summary
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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.

Official Title
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The Study of Atypical Antipsychotics-induced Metabolic Disturbances

Conditions
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Schizophrenia, Antipsychotics

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| olanzapine<br>olanzapine 10-20 mg/day | |
| quetiapine<br>quetiapine 300-600 mg/day | |
| risperidone<br>risperidone monotherapy, 2-4 mg/day | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose homeostasis |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid homeostasis |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, antipsychotics, glucose homeostasis, metabolic disturbance