NCT00205725

Brief Summary

Abnormalities in peripheral glucose regulation and type 2 diabetes can occur more commonly in individuals with schizophrenia than in healthy subjects or in other psychiatric conditions. Antipsychotic treatment may contribute significantly to abnormalities in glucose regulation. Hyperglycemia can contribute to long-term cardiovascular disease risk that may already be increased in patients with schizophrenia due to higher rates of smoking, sedentary life style, obesity and under-treated hypertension and dyslipidemia. This project will characterize the effects on glucose control of the two most commonly prescribed newer antipsychotic medications, ziprasidone and olanzapine, in patients with schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Nov 2000

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

March 13, 2014

Status Verified

March 1, 2014

Enrollment Period

5.9 years

First QC Date

September 13, 2005

Last Update Submit

March 12, 2014

Conditions

SchizophreniaType 2 Diabetes Mellitus

Keywords

SchizophreniaBMIT2DM

Outcome Measures

Primary Outcomes (1)

  • Effects of olanzapine/ziprasidone/haloperidol on glucose regulation

Secondary Outcomes (1)

  • Explore treatment-related effects on glucose effectiveness

Interventions

Ziprasidone, OlanzapineDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients: meets DSM-IV criteria for schizophrenia, any type, or schizoaffective disorder;
  • aged 18 to 60 years;
  • able to give informed consent;
  • no medication changes for 2 weeks prior to and during the period of study;
  • Patients: currently taking an antipsychotic.

You may not qualify if:

  • Controls: Axis I psychiatric disorder criteria met except for substance use disorders as below;
  • meets DSM-IV criteria for the diagnoses of substance abuse or dependence within the past six months;
  • involuntary legal status (as per Missouri law);
  • the presence of any serious medical disorder that may (as confirmed by peer-reviewed literature) confound the assessment of symptoms, relevant biologic measures or diagnosis;
  • the following conditions are currently identified:
  • insulin- or non-insulin-dependent diabetes mellitus;
  • any intra-abdominal or intrathoracic surgery or limb amputation within the prior 6 months;
  • any diagnosed cardiac condition causing documented hemodynamic compromise;
  • any diagnosed respiratory condition causing documented or clinically recognized hypoxia;
  • pregnancy or high dose estrogens, fever, narcotic therapy, acute sedative hypnotic withdrawal, corticosteroid or spironolactone therapy, dehydration, epilepsy, endocrine disease, high-dose benzodiazepine therapy (\> 25 mg/day of diazepam), or any medical condition known to interfere with glucose utilization;
  • meets DSM-IV criteria for Mental Retardation (mild or worse).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine, Psychiatry Dept.

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

  • Haupt DW, Fahnestock PA, Flavin KA, Schweiger JA, Stevens A, Hessler MJ, Maeda J, Yingling M, Newcomer JW. Adiposity and insulin sensitivity derived from intravenous glucose tolerance tests in antipsychotic-treated patients. Neuropsychopharmacology. 2007 Dec;32(12):2561-9. doi: 10.1038/sj.npp.1301392. Epub 2007 Mar 21.

    PMID: 17375138RESULT

  • Haupt DW, Luber A, Maeda J, Melson AK, Schweiger JA, Newcomer JW. Plasma leptin and adiposity during antipsychotic treatment of schizophrenia. Neuropsychopharmacology. 2005 Jan;30(1):184-91. doi: 10.1038/sj.npp.1300563.

    PMID: 15367925RESULT

MeSH Terms

Conditions

SchizophreniaDiabetes Mellitus, Type 2

Interventions

ziprasidoneOlanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • John W. Newcomer, M.D.

    Washington University School of Medicine and Florida Atlantic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

November 1, 2000

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

March 13, 2014

Record last verified: 2014-03

Locations

US(1)