SchizophreniaDLWNCT00836251
Effects of Antipsychotic Medications on Energy Intake and Expenditure
An observational study of Schizophrenia and Schizoaffective Disorder, run by Washington University School of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Weight Gain
- What is being tested?
- H218O and 2H2O, administered as a mixed cocktail
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Jun 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Males and females, ages 18-80, diagnosed with schizophrenia or schizoaffective disorder
Who may be able to join
- non-diabetic
- schizophrenic or schizoaffective
- currently prescribed olanzapine or ziprasidone
- 18-80 y.o.
Who cannot join
- <18 or >80 years of age
- diabetic
- not schizophrenic or schizoaffective
- not currently prescribed olanzapine or ziprasidone
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 53110
About this study
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.
Read the 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder, Weight Gain
- Being tested
- H218O and 2H2O, administered as a mixed cocktail
- Keywords
- energy expenditure, schizophrenia
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H218O and 2H2O, administered as a mixed cocktailDietary supplement
0.195 g of H218O and 0.117 g of 2H2O per kg of estimated total body water (TBW), administered as a mixed cocktail
| Study group | Role | What they receive |
|---|---|---|
| H218O and 2H2O | schizophrenia Receives: Dietary Supplement: H218O and 2H2O, administered as a mixed cocktail |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment-induced changes in Total Energy Expenditure (TEE), Activity Energy Expenditure (AEE), and Energy Intake (EI)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startApr 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John W Newcomer, MD, Principal investigator, Florida Atlantic UniversityGinger Nicol, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836251
- Sponsor's protocol ID
- 06-0246
- Acronym
- DLW
- Status last verified
- Mar 2014
- First submitted
- 3 Feb 2009
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Antipsychotic Medications on Energy Intake and Expenditure
- ClinicalTrials.gov ID
- NCT00836251
- Acronym / sponsor ID
- DLW / 06-0246
- Conditions
- Schizophrenia, Schizoaffective Disorder, Weight Gain
- Keywords
- energy expenditure, schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H218O and 2H2O | – | Dietary Supplement: H218O and 2H2O, administered as a mixed cocktailschizophrenia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females, ages 18-80, diagnosed with schizophrenia or schizoaffective disorder
Key inclusion criteria (4 listed)
- non-diabetic
- schizophrenic or schizoaffective
- currently prescribed olanzapine or ziprasidone
- 18-80 y.o.
Key exclusion criteria (4 listed)
- <18 or >80 years of age
- diabetic
- not schizophrenic or schizoaffective
- not currently prescribed olanzapine or ziprasidone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H218O and 2H2O, administered as a mixed cocktail0.195 g of H218O and 0.117 g of 2H2O per kg of estimated total body water (TBW), administered as a mixed cocktail | Dietary supplement | H218O and 2H2O |
Primary outcome
treatment-induced changes in Total Energy Expenditure (TEE), Activity Energy Expenditure (AEE), and Energy Intake (EI)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John W Newcomer, MD principal investigator
Florida Atlantic University
Ginger Nicol, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Schizoaffective Disorder, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment-induced changes in Total Energy Expenditure (TEE), Activity Energy Expenditure (AEE), and Energy Intake (EI) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2014.