Expired Study
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St. Louis, Missouri 53110


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.


Study summary:

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.


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


Study is Available At:


Original ID:

06-0246


NCT ID:

NCT00836251


Secondary ID:


Study Acronym:

DLW


Brief Title:

Effects of Antipsychotic Medications on Energy Intake and Expenditure


Official Title:

Effects of Antipsychotic Medications on Energy Intake and Expenditure


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Washington University School of Medicine


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: Pro


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

15


Enrollment Type:

Actual


Overall Contact Information

Official Name:John W Newcomer, MD
Principal Investigator
Florida Atlantic University

Study Dates

Start Date:April 2006
Completion Date:June 2008
Completion Type:Actual
Primary Completion Date:June 2008
Primary Completion Type:Actual
Verification Date:March 2014
Last Changed Date:March 12, 2014
First Received Date:February 3, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure:treatment-induced changes in Total Energy Expenditure (TEE), Activity Energy Expenditure (AEE), and Energy Intake (EI)
Time Frame:12 weeks
Safety Issues:False

Study Interventions

Intervention Type:Dietary Supplement
Name:H218O and 2H2O, administered as a mixed cocktail
Description:0.195 g of H218O and 0.117 g of 2H2O per kg of estimated total body water (TBW), administered as a mixed cocktail
Arm Name:H218O and 2H2O

Study Arms

Study Arm Type:Other
Arm Name:H218O and 2H2O
Description:schizophrenia

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Washington University School of Medicine

Samples and Retentions

Study Population: Males and females, ages 18-80, diagnosed with schizophrenia or schizoaffective disorder
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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