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Completed

NCT Number: NCT00937755

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Taipei Medical University-Municipal Wan-Fang Hospital

Taipei, 116, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. glucose homeostasis

    Time frame: 8 weeks

Secondary outcomes

  1. lipid homeostasis

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Taipei Medical University Hospital

Other

Collaborators

  • Department of Health, Executive Yuan, R.O.C. (Taiwan)
  • National Science and Technology Council, Taiwan

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jul 13, 2009
Registry last updated
Jul 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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