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Pharmacogenetic Profiling of Antipsychotics-Induced X-Syndrome and Diabetes (PAXD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00201292
Recruitment Status : Unknown
Verified May 2007 by National Health Research Institutes, Taiwan.
Recruitment status was:  Recruiting
First Posted : September 20, 2005
Last Update Posted : November 15, 2007
Taipei City Hospital
Mackay Memorial Hospital
Department of Health Yuli Hospital
Information provided by:
National Health Research Institutes, Taiwan

Brief Summary:

Diabetes is prevalent in schizophrenics and may be induced by antipsychotic treatments. Several retrospective studies have suggested that psychiatric patients exposed to atypical antipsychotics may be at a higher risk for developing diabetes and ketoacidosis. The association between these atypical antipsychotics and the onset of diabetes is further strengthened by observations of:

  1. the time sequence between the initiation of antipsychotic treatment and the onset of diabetes;
  2. remission after the discontinuation of medications; and
  3. re-emergence of diabetes following the re-introduction of atypical antipsychotics.

The treatment emergent diabetes, along with other metabolic disturbances, represents a serious issue in the use of atypical antipsychotics. Major current debates and unresolved research issues which are also the focus of this proposal, are:

  1. schizophrenia per se, versus the use of antipsychotics, in triggering diabetes;
  2. whether there are differences between "typicals" and "atypicals" in such an effect;
  3. whether there are differences among different "atypicals";
  4. whether, and to what extent, treatment emergent diabetes may be associated with, or independent of, weight gain, which also often is associated with the use of antipsychotics; and
  5. genetic and environmental risks in association with treatment emergent diabetes.

The policy of some hospitals in Taiwan that discourages the use of atypical antipsychotics for new onset schizophrenia directs the investigators to a study design looking at the associated diabetes of both types of antipsychotics. Such a design may provide some hints to the unresolved research issues mentioned above.

Meanwhile, a broader defined term, X-syndrome, or metabolic syndrome, is being used to describe the diabetic condition associated with antipsychotics. X-syndrome is a risky condition leading to cardiovascular diseases and diabetes, with insulin resistance as the major outcome, associated with two of the following conditions: truncal obesity (deposited in the thorax and abdomen, instead of the hips and thighs), high triglycerides, high low-density lipoprotein (LDL) cholesterol or hypertension. The proposed study will combine the phenotypes of diabetes and X-syndrome to explore the abnormal metabolism caused by antipsychotics, bridge important information gaps, and provide data contributing towards a better understanding of the risk and management of diabetes and X-syndrome associated with the use of antipsychotics. Three assessment tools, namely the Clinical Global Severity (Clinical Global Impressions - Severity) or the Positive and Negative Symptom Scale (PANNS), the Diabetes Risk Assessment (ADA) and the Life Style Survey, together with physical measurements, collect additional information for this study. Diabetes related biochemistry, including glucose, insulin, leptin, lipids and glycohemoglobin, will be measured to form a composite phenotype for further pharmacogenetic studies. Candidate genes involved in pancreatic beta cell insulin secretion will be examined in priority to see if they play a role in the development of the antipsychotics-induced diabetes.

Condition or disease
Metabolic Syndrome Diabetes

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Study Type : Observational
Estimated Enrollment : 1350 participants
Official Title: Pharmacogenetic Profiling of Antipsychotics-Induced X-Syndrome and Diabetes (PAXD)
Study Start Date : March 2005
Estimated Study Completion Date : October 2008

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Inpatients and outpatients diagnosed with schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria
  • Treated either with typical or atypical antipsychotics

Exclusion Criteria:

  • Illegal drug use/abuse/dependence
  • Alcoholism
  • Pregnancy
  • Clinical diagnosis of type I or type II diabetes before the onset of schizophrenia or treatment of schizophrenia (via chart review).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00201292

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Contact: El-Wui Loh, PhD 886-2-26534401 ext 26715

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Department of Health-Yuli Hospital Recruiting
Yuli, Hu-lien County, Taiwan, 981
Contact: Tsuo Hung Lan, MD, PhD         
Principal Investigator: Tsuo Hung Lan, MD, PhD         
Song-de Branch, Taipei City Hospital Not yet recruiting
Taipei, Taiwan, 110
Contact: Shih-Ku Lin, MD         
Principal Investigator: Shih-Ku Lin, MD         
Mackay Memorial Hospital Not yet recruiting
Taipei, Taiwan
Contact: Shen-Ing Liu, MD, PhD         
Principal Investigator: Shen-Ing Liu, MD, PhD         
Sponsors and Collaborators
National Health Research Institutes, Taiwan
Taipei City Hospital
Mackay Memorial Hospital
Department of Health Yuli Hospital
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Principal Investigator: El-Wui Loh, PhD Division of Mental Health and Drug Abuse Research, National Health Research Institutes
Layout table for additonal information Identifier: NCT00201292    
Other Study ID Numbers: EC0931203
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: November 15, 2007
Last Verified: May 2007
Keywords provided by National Health Research Institutes, Taiwan:
Metabolic syndrome
Insulin resistance
Additional relevant MeSH terms:
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Diabetes Mellitus
Metabolic Syndrome
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Insulin Resistance