Pharmacogenetic Profiling of Antipsychotics-Induced X-Syndrome and Diabetes (PAXD - Clinical Trials for Diabetic Mental Problems

Pharmacogenetic Profiling of Antipsychotics-Induced X-Syndrome and Diabetes (PAXD)
This study is currently recruiting participants.
Verified by National Health Research Institutes, Taiwan, May 2007
Sponsors and Collaborators: National Health Research Institutes, Taiwan
Taipei City Hospital
Mackay Memorial Hospital
Department of Health Yuli Hospital

Information provided by: National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier: NCT00201292

Purpose
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:

the time sequence between the initiation of antipsychotic treatment and the onset of diabetes;
remission after the discontinuation of medications; and
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:

schizophrenia per se, versus the use of antipsychotics, in triggering diabetes;
whether there are differences between "typicals" and "atypicals" in such an effect;
whether there are differences among different "atypicals";
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
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
Metabolic Syndrome
Diabetes

MedlinePlus related topics: Diabetes
Drug Information available for: Insulin
U.S. FDA Resources
Study Type:Observational
Official Title:Pharmacogenetic Profiling of Antipsychotics-Induced X-Syndrome and Diabetes (PAXD)

Further study details as provided by National Health Research Institutes, Taiwan:

Estimated Enrollment:1350
Study Start Date:March 2005
Estimated Study Completion Date:October 2008

Eligibility
Ages Eligible for Study:18 Years to 65 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria
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).
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201292

Contacts
Contact: El-Wui Loh, PhD 886-2-26534401 ext 26715 eloh@nhri.org.tw

Locations
Taiwan
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
Taiwan, Hu-lien County
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

Sponsors and Collaborators
National Health Research Institutes, Taiwan
Taipei City Hospital
Mackay Memorial Hospital
Department of Health Yuli Hospital
Investigators
Principal Investigator: El-Wui Loh, PhD Division of Mental Health and Drug Abuse Research, National Health Research Institutes

Study ID Numbers:EC0931203, MD-094-PP-04
First Received:September 12, 2005
Last Updated:November 14, 2007
ClinicalTrials.gov Identifier:NCT00201292 [history]
Health Authority:Taiwan: Department of Health

Keywords provided by National Health Research Institutes, Taiwan:
Metabolic syndrome
Diabetes
Insulin resistance
pharmacogenetics

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Insulin Resistance
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome