The Study of Atypical Antipsychotics-induced Metabolic Disturbances

NCT ID: NCT00937755

Last Updated: 2009-07-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2009-05-31

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.

Conditions

Schizophrenia; Antipsychotics

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

olanzapine

olanzapine 10-20 mg/day

No interventions assigned to this group

quetiapine

quetiapine 300-600 mg/day

No interventions assigned to this group

risperidone

risperidone monotherapy, 2-4 mg/day

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Department of Health, Executive Yuan, R.O.C. (Taiwan)

OTHER_GOV

Sponsor Role: collaborator

Taipei Medical University Hospital

OTHER

Sponsor Role: lead

Locations

Taipei Medical University-Municipal Wan-Fang Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

F941101

Identifier Type: -

Identifier Source: org_study_id