The Study of Atypical Antipsychotics-induced Metabolic Disturbances
|ClinicalTrials.gov Identifier: NCT00937755|
Recruitment Status : Completed
First Posted : July 13, 2009
Last Update Posted : July 13, 2009
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.
|Condition or disease||Phase|
|Schizophrenia Antipsychotics||Phase 4|
|Study Type :||Observational|
|Actual Enrollment :||80 participants|
|Official Title:||The Study of Atypical Antipsychotics-induced Metabolic Disturbances|
|Study Start Date :||March 2006|
|Primary Completion Date :||March 2009|
|Study Completion Date :||May 2009|
olanzapine 10-20 mg/day
quetiapine 300-600 mg/day
risperidone monotherapy, 2-4 mg/day
- glucose homeostasis [ Time Frame: 8 weeks ]
- lipid homeostasis [ Time Frame: 8 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00937755
|Taipei Medical University-Municipal Wan-Fang Hospital|
|Taipei, Taiwan, 116|