Side Effects of Antipsychotic Medications

NCT00363181 | Completed

• 1 other identifier: F1DMC-X280
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Insulin resistance; Metabolic problems; Weight gain; Mental health problems; Mental disorders; Antipsychotic medication; Olanzapine

Eligibility Criteria

• Age: 30 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304-1290, United States

Location

MeSH Terms

Conditions

Insulin Resistance; Metabolic Syndrome; Schizophrenia Spectrum and Other Psychotic Disorders; Mood Disorders; Psychotic Disorders; Weight Gain; Mental Disorders

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Steven E Lindley, MD, PhD

  Stanford School of Medicine / VA Palo Alto

  PRINCIPAL INVESTIGATOR

• Gerald M Reaven, MD

  Stanford School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2006
• First Posted: August 15, 2006
• Study Start: April 1, 2006
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)