The Study of Atypical Antipsychotics-induced Metabolic Disturbances

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Antipsychotics

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 116
    • Taipei Medical University-Municipal Wan-Fang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

psychiatric outpatient clinic and inpatient units

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
olanzapine; olanzapine 10-20 mg/day
quetiapine; quetiapine 300-600 mg/day
risperidone; risperidone monotherapy, 2-4 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
glucose homeostasis	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
lipid homeostasis	8 weeks

Collaborators and Investigators

• Sponsor: Taipei Medical University Hospital
• Collaborators: Department of Health, Executive Yuan, R.O.C. (Taiwan); National Science Council, Taipei, Taiwan

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: July 10, 2009
• First Submitted That Met QC Criteria: July 10, 2009
• First Posted (Estimate): July 13, 2009

Study Record Updates

• Last Update Posted (Estimate): July 13, 2009
• Last Update Submitted That Met QC Criteria: July 10, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: schizophrenia; antipsychotics; glucose homeostasis; metabolic disturbance
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: F941101