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Effects of Antipsychotic Medications on Energy Intake and Expenditure (DLW)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00836251
First received: February 3, 2009
Last updated: April 11, 2013
Last verified: April 2013
History of Changes
  Purpose

Aim 1: To evaluate the effect of antipsychotic treatment group on Activity Energy Expenditure. The project hypothesizes that subjects treated with olanzapine will demonstrate a greater decrease in AEE over time than subjects treated with ziprasidone, due at least in part to sedating effects of olanzapine.

Aim 2: To evaluate the effect of antipsychotic treatment group on Energy Intake. The project hypothesizes that subjects treated with olanzapine will demonstrate a greater increase in EI over time than subjects treated with ziprasidone, based on higher histamine type 1 (H1) receptor affinity of olanzapine and the relationship between H1 affinity and hunger and/or satiety.


Condition Intervention
Schizophrenia
Schizoaffective Disorder
Weight Gain
 Dietary Supplement: H218O and 2H2O, administered as a mixed cocktail

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Antipsychotic Medications on Energy Intake and Expenditure

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • treatment-induced changes in Total Energy Expenditure (TEE), Activity Energy Expenditure (AEE), and Energy Intake (EI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: April 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
H218O and 2H2O
schizophrenia
 Dietary Supplement: H218O and 2H2O, administered as a mixed cocktail
0.195 g of H218O and 0.117 g of 2H2O per kg of estimated total body water (TBW), administered as a mixed cocktail

Detailed Description:

The overall purpose of this research is to determine how two commonly prescribed antipsychotic medications, olanzapine (Zyprexa) and ziprasidone (Geodon), affect weight gain through increasing appetite and/or through increasing sedation that results in decreased activity.

Undesirable changes in body weight, blood sugar control, type 2 diabetes, and blood lipids occur more commonly in people who have schizophrenia than in people without psychiatric conditions. Although differences in glucose regulation were first reported in schizophrenia before the use of antipsychotic medications, antipsychotic treatment may contribute to these problems, though just how this happens is not understood. This study proposes to use a doubly-labeled water (DLW) method to measure the degree to which weight gain (fat mass) is due to increased appetite, decreased physical activity from being tired and sleepy, or some combination of both. Doubly-labeled water contains stable isotopes (non-radioactive forms) of the hydrogen and oxygen that make up all water, isotopes that will be slowly passed out through the urine after participants drink DLW. The number of hydrogen and oxygen isotopes found in the urine samples will tell us how many calories the participant's body has been using.

The DLW method has been used in people with obesity and other types of medical problems. It's recognized as the most accurate measure of the number of calories burned throughout a typical day, and how many calories are taken in from food and drink. By measuring these factors in people who take antipsychotic medications, doctors will gain a better understanding of the effects of antipsychotic medications on body weight and fat mass. This could lead to the development of better ways to prevent or treat weight gain or diabetes in patients who take antipsychotic medications.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Males and females, ages 18-80, diagnosed with schizophrenia or schizoaffective disorder

Criteria

Inclusion Criteria:

  • non-diabetic
  • schizophrenic or schizoaffective
  • currently prescribed olanzapine or ziprasidone
  • 18-80 y.o.

Exclusion Criteria:

  • <18 or >80 years of age
  • diabetic
  • not schizophrenic or schizoaffective
  • not currently prescribed olanzapine or ziprasidone
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836251

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 53110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: John W Newcomer, MD University of Miami
Principal Investigator: Ginger Nicol, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00836251     History of Changes
Other Study ID Numbers: 06-0246
Study First Received: February 3, 2009
Last Updated: April 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
energy expenditure
schizophrenia

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Weight Gain
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Body Weight Changes
Body Weight
Signs and Symptoms
 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 May 23, 2013