Janssen - Glucose Regulation/Risp/Olanz

NCT00205738 | Completed

• 2 other identifiers: Janssen IVGTT/94078000-0306
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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, risperidone and olanzapine, in patients with schizophrenia. This proposal specifically hypothesizes that olanzapine treatment will be associated with decreases in insulin sensitivity (SI), without effects on insulin secretion. Treatment-related effects on glucose effectiveness (SG) will be explored.

Conditions

Schizophrenia; Type 2 Diabetes Mellitus

Keywords

Schizophrenia; BMI; T2DM

Outcome Measures

Primary Outcomes (1)

• Effects of olanzapine/risperidone/haloperidol on glucose regulation.

Secondary Outcomes (1)

• Explore Treatment-related effects on glucose effectiveness.

Interventions

Risperidone, Olanzapine DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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; 5. Patients: currently taking olanzapine, risperidone, haloperidol or another typical 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).

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Janssen, LP: collaborator

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: 17375138 RESULT

• 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: 15367925 RESULT

MeSH Terms

Conditions

Schizophrenia; Diabetes Mellitus, Type 2

Interventions

Risperidone; Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

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: July 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)