NCT00201292

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. 1.the time sequence between the initiation of antipsychotic treatment and the onset of diabetes;
  2. 2.remission after the discontinuation of medications; and
  3. 3.re-emergence of diabetes following the re-introduction of atypical antipsychotics.
  4. 4.schizophrenia per se, versus the use of antipsychotics, in triggering diabetes;
  5. 5.whether there are differences between "typicals" and "atypicals" in such an effect;
  6. 6.whether there are differences among different "atypicals";
  7. 7.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
  8. 8.genetic and environmental risks in association with treatment emergent diabetes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2005

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

November 15, 2007

Status Verified

May 1, 2007

First QC Date

September 12, 2005

Last Update Submit

November 14, 2007

Conditions

Metabolic SyndromeDiabetes

Keywords

Metabolic syndromeDiabetesInsulin resistancepharmacogenetics

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Health-Yuli Hospital

Yuli, Hu-lien County, 981, Taiwan

RECRUITING

Song-de Branch, Taipei City Hospital

Taipei, Taipei, 110, Taiwan

NOT YET RECRUITING

Mackay Memorial Hospital

Taipei, Taipei, Taiwan

NOT YET RECRUITING

MeSH Terms

Conditions

Metabolic SyndromeDiabetes MellitusInsulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • El-Wui Loh, PhD

    Division of Mental Health and Drug Abuse Research, National Health Research Institutes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

El-Wui Loh, PhD

CONTACT

886-2-26534401eloh@nhri.org.tw

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

March 1, 2005

Study Completion

October 1, 2008

Last Updated

November 15, 2007

Record last verified: 2007-05

Locations

TW(3)