Side Effects of Antipsychotic Medications

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00363181
First received: August 9, 2006
Last updated: March 19, 2007
Last verified: March 2007
  Purpose

Medications like olanzapine have been associated with the development of weight gain and diabetes in some patients. It is not known if the increased risk of developing diabetes is a direct effect on insulin or simply related to weight gain.

We hope to learn in this study whether or not olanzapine directly slows down insulin secretion from the pancreas, thereby increasing the risk of developing diabetes.


Condition
Insulin Resistance
Metabolic Syndrome X
Schizophrenia and Disorders With Psychotic Features
Mood Disorders
Psychotic Disorders

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
Official Title: Does Olanzapine Inhibit the Secretory Response to Insulin Resistance?

Resource links provided by NLM:


Further study details as provided by Stanford University:

Estimated Enrollment: 120
Study Start Date: April 2006
Detailed Description:

Objectives: The use of atypical antipsychotics has been associated with increased weight gain, the development of type-2 diabetes, and, in rare cases, diabetic ketoacidosis. It is not clear if these changes are a direct function of antipsychotics on either insulin action or insulin secretion, or simply related to their ability to induce weight gain in a population at increased risk to develop hyperglycemia. The objective of this investigation is to determine if treatment with the atypical antipsychotics olanzapine impairs the ability of the pancreatic beta cell to increase its insulin secretory response to graded increases in plasma glucose concentration in non-diabetic, insulin resistant individuals. In addition, we will compare the range of insulin-mediated glucose uptake (IMGU) in olanzapine-treated versus non-antipsychotic treated patients.

Research Plan and Methods: 120 subjects with psychiatric disorders will be enrolled; 60 patients on olanzapine and 60 patients with similar psychiatric diagnoses on a different antipsychotic medication (ziprasidone, risperidone or aripiprazole). All subjects will have a fasting plasma glucose concentration <126 mg/dL, and on no medication with a direct effect on IMGU. Subjects will be admitted to the General Clinical Research Center (GCRC) at Stanford Medical Center and evaluated by an insulin suppression test (IST) to determine their IMGU. Subjects with a steady state plasma glucose (SSPG) concentration during the IST that is >180 mg/dL will be defined as being insulin resistant. From this population of subjects, 15 patients on olanzapine and 15 patients not on any antipsychotic, will return to the GCRC to determine their glucose-stimulated insulin secretory dose-response curves (GS-ISR). The GS-ISR at the same glucose concentration will be compared between the subjects on olanzapine (n=15) and the not on an antipsychotic (n=15) by analysis of variance. Analyses of the 120 subjects screened for insulin resistance will compare 1) the means and distribution of the SSPG concentrations in olanzapine and non-olanzapine treated patients with psychiatric diagnoses; and 2) the means of the two experimental groups with psychiatric diagnoses to Dr. Reaven’s data base of volunteers without psychiatric disorders.

  Eligibility

Ages Eligible for Study:   30 Years to 66 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants 30-66 years of age
  • Body mass index (BMI) >25 < 35 kg/m2.
  • Fasting plasma glucose concentration < 126 mg/dL
  • Stable on one of the following psychiatric medication: Olanzapine (Zyprexa®), Ziprasidone (Geodon®), Aripiprazole (Abilify®), or Risperidone (Risperdal®)
  • Stable on psychiatric medication for at least 3 months

Exclusion Criteria:

  • Medications that directly affect insulin-mediated glucose disposal
  • Intense suicidal impulses/intent
  • Alcohol or substance abuse for 3 months.
  • Major medical problems, i.e., clinically unstable medical disorder or condition; cardiovascular, hepatic, renal, gastrointestinal, pulmonary, endocrine or other systemic disease that would, in the investigator's clinical judgment interfere with the endocrine measures obtained in this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363181

Contacts
Contact: Lilla Nikolics, Ms 650-493-5000 ext 67289 lilla.nikolics@va.gov
Contact: Contact email olanzapine.research@gmail.com

Locations
United States, California
VA Palo Alto Health Care System Recruiting
Palo Alto, California, United States, 94304-1290
Principal Investigator: Steven E Lindley, MD, PhD         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Steven E Lindley, MD, PhD Stanford School of Medicine / VA Palo Alto
Principal Investigator: Gerald M Reaven, MD Stanford School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00363181     History of Changes
Other Study ID Numbers: F1DMC-X280
Study First Received: August 9, 2006
Last Updated: March 19, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Insulin resistance
Metabolic problems
Weight gain
Mental health problems
Mental disorders
Antipsychotic medication
Olanzapine

Additional relevant MeSH terms:
Schizophrenia
Metabolic Syndrome X
Insulin Resistance
Mental Disorders
Psychotic Disorders
Mood Disorders
Disease
Schizophrenia and Disorders with Psychotic Features
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pathologic Processes
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 22, 2014