The Study of Atypical Antipsychotics-induced Metabolic Disturbances

NCT00937755 | Completed

• 1 other identifier: F941101
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

schizophrenia; antipsychotics; glucose homeostasis; metabolic disturbance

Outcome Measures

Primary Outcomes (1)

• glucose homeostasis

  8 weeks

Secondary Outcomes (1)

• lipid homeostasis

  8 weeks

Study Arms (3)

olanzapine

olanzapine 10-20 mg/day

quetiapine

quetiapine 300-600 mg/day

risperidone

risperidone monotherapy, 2-4 mg/day

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

psychiatric outpatient clinic and inpatient units

You may qualify if:

• clinical diagnosis of schizophrenia
• age 18-60 years

You may not qualify if:

• received any SGAs prior to this study
• medical conditions that may confound glucoregulatory assessment
• pregnancy

Sponsors & Collaborators

• Taipei Medical University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator
• Department of Health, Executive Yuan, R.O.C. (Taiwan): collaborator

Study Sites (1)

Taipei Medical University-Municipal Wan-Fang Hospital

Taipei, 116, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 10, 2009
• First Posted: July 13, 2009
• Study Start: March 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: May 1, 2009
• Last Updated: July 13, 2009

Record last verified: 2009-07

Locations

TW (1)