The Study of Atypical Antipsychotics-induced Metabolic Disturbances

Schizophrenia Clinical Trial

Official title:

The Study of Atypical Antipsychotics-induced Metabolic Disturbances

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937755
• Other study ID #: F941101
• Status: Completed
• Phase: Phase 4
• First received: July 10, 2009
• Last updated: July 10, 2009
• Start date: March 2006
• Est. completion date: May 2009

Study information

• Verified date: July 2009
• Source: Taipei Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Antipsychotics
• Schizophrenia

Locations

Country	Name	City	State
Taiwan	Taipei Medical University-Municipal Wan-Fang Hospital	Taipei

Sponsors (3)

Lead Sponsor	Collaborator
Taipei Medical University Hospital	Department of Health, Executive Yuan, R.O.C. (Taiwan), National Science Council, Taipei, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glucose homeostasis		8 weeks	Yes
Secondary	lipid homeostasis		8 weeks	Yes