Mental DisordersNCT00894738
Measurement of Cardiometabolic Risk in Antipsychotic-Treated Children
An observational study of Mental Disorders, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The proposed study aims to begin the multi-step process of establishing the reliability and validity of hepatic triglyceride content (HTGC) and carotid artery intima-media thickness (IMT) as biomarkers of cardiometablic risk in children treated for mental illness. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Testing (MRS, US, DEXA, blood tests)
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2010to 1 Jun 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children ages 6-18 who are currently being treated for a psychiatric condition with an antipsychotic medication, and age- and gender-matched healthy controls who are not treated with an antipsychotic medication.
The inclusion criteria for the treatment group participants are: i) aged approximately 6-18 years; ii) BMI percentile between approximately 25 and 99; iii) otherwise healthy and meets DSM-IV criteria for one or more childhood onset psychiatric disorder, any type (determined by semi-structured Missouri Assessment of Genetics Interview for Children or MAGIC-described below and at the discretion of the PI), treated with an antipsychotic > approximately 12 weeks; iv) able to give assent and have a guardian that can provide informed consent; and v) no antipsychotic medication dose changes for approximately 1 month, and no other medication changes for 1 month prior to study enrollment.
The inclusion criteria for healthy controls are: i) aged 6-18 years; ii) BMI percentile between approximately 25 and 99 iii) otherwise healthy and at the PI's discretion do not meet DSM-IV criteria for any Axis I psychiatric illness; iv) not currently taking any medications; and v) able to give assent, and have a guardian that can provide informed consent.
The exclusion criteria are: i) active suicidality or a primary diagnosis of major depressive disorder; ii) any lifetime use of antipsychotics; individual subjects with a remote, brief prior antipsychotic exposure may be considered for enrollment on a case by case basis by the PI; iii) the presence of any serious medical disorder that may confound the assessment of relevant biologic measures or diagnoses, including: significant organ system dysfunction; endocrine disease, including type 1 or type 2 diabetes mellitus; coagulopathy; anemia; or acute infection; all based on PI discretion; iv) subjects regularly taking within the last 3 months any glucose lowering agent, lipid lowering agent, exogenous testosterone, recombinant human growth hormone, or any other endocrine agent that might confound substrate metabolism, oral glucocorticoids (glucocorticoid nasal spray and inhalers are permitted), sedating antihistamines (non-sedating antihistamines such as but not limited to Claritin (loratadine) and Zyrtec (cetirizine) are permitted), and certain mood stabilizing agents, as some medications may themselves worsen or otherwise alter weight gain, glucose and lipid regulation or otherwise make it difficult to assess the effects of the antipsychotic alone; (note that exposure to many psychotropic agents including stimulants and SSRI's is permitted in order to maintain the generalizability of the sample); v) IQ < 70 (based on school records and/or evaluation by clinician); vi) current substance abuse; vii) past history of, or current dyskinesia; viii) stimulant dosage significantly higher (per PI judgment) than the equivalent of approximately 2 mg/kg/day methylphenidate equivalent dose.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Biomarkers of Cardiometabolic Risk in Children Treated With Antipsychotics: A Preliminary Study of Direct Measures
The proposed study aims to begin the multi-step process of establishing the reliability and validity of hepatic triglyceride content (HTGC) and carotid artery intima-media thickness (IMT) as biomarkers of cardiometablic risk in children treated for mental illness. The distribution of HTGC and carotid IMT-proximate indicators of cardiometabolic risk-across a range of dual-energy X-ray absorptiometry (DEXA)-measured adiposity in children treated with antipsychotic agents will be characterized in comparison to healthy, untreated, non-psychiatric controls, in order to estimate effect sizes for future studies incorporating these markers. The ability of HTGC and IMT to predict cardiometabolic risk as measured by commonly-used laboratory tests, such as fasting lipids, liver function tests, C-reactive protein and serum fibrinogen, will be assessed.
Read the detailed description
Carotid artery intima media wall thickness (IMT) is one of the most developed biomarkers of cardiometabolic risk, with established reliability and predictive validity, and has been utilized as a surrogate endpoint for cardiovascular disease progression in FDA-reviewed registration studies. This technique has also been used in children and adolescents without psychiatric disorders, indicating that changes in IMT are positively correlated with metabolic syndrome criteria. Magnetic Resonance Spectroscopy (1H MRS) to quantify hepatic triglyceride content (HTGC) is a promising new marker of cardiometabolic risk, especially given the importance of nocturnal circulating free fatty acids in the development of insulin resistance leading to type 2 diabetes. Fatty liver, related in part to obesity, is the most common liver abnormality found in children ages 2-19, with one in ten children manifesting signs of macrovascular steatohepatitis. 1H MRS is a well-established methodology used to measure HTGC that correlates well with liver biopsy results. This technique has been studied in obese children without psychiatric disorders, and is widely considered to be the optimal noninvasive means by which to measure HTGC. Unfortunately, neither of these promising methods have been applied to the study of cardiometabolic risk in children with psychiatric disorders.
It is important to now study these biomarkers in psychiatric populations, where individuals are subject to treatments that can increase risk. Our group is experienced in the application of sophisticated, gold standard techniques for measuring cardiometabolic risk in psychiatric populations, and is-to our knowledge-the only group in the US using sensitive methodologies like stable isotopomer euglycemic clamps to study the pathophysiology leading to diabetes and cardiovascular disease in the mentally ill. An important goal of studying these biomarkers is to ultimately determine which of the more commonly available conventional risk measures (e.g., lipid profiles, adiposity measures) can be used alone or in combination to accurately identify children at highest risk, to aid in the development and targeting of effective interventions.
- Conditions
- Mental Disorders
- Being tested
- Testing (MRS, US, DEXA, blood tests)
- Keywords
- pediatric, mental illness, antipsychotic, cardiometabolic risk, Antipsychotic agents, Mental disorders diagnosed in childhood
- Medical subject headings
- Mental Disorders, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing (MRS, US, DEXA, blood tests)Procedure or surgery
Magnetic Resonance Spectroscopy (MRS) of the liver to determine hepatic triglyceride content; ultrasound (US) of the carotid artery to determine intima-media thickness; dual energy X-ray absorptiometry (DEXA) to determine body composition; fasting lipids, fasting insulin, C-reactive protein, liver enzymes and fibrinogen levels.
| Study group | Role | What they receive |
|---|---|---|
| antipsychotic treated | Children with psychiatric diagnoses who are currently treated with antipsychotic medications. Receives: Procedure: Testing (MRS, US, DEXA, blood tests) | |
| healthy control | Age- and gender-matched children who do not have a psychiatric diagnosis, are not taking antipsychotic medications, and are otherwise healthy. Receives: Procedure: Testing (MRS, US, DEXA, blood tests) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid Artery Intima-media Thickness Measured by Ultrasonography.
Measured: Week 1
Intrahepatic Triglyceride Content (IHTG) Measure by Liver Magnetic Resonance Spectroscopy.
Measured: Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study start1 Jan 2010
- Primary completion31 Mar 2016
- Study completion1 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mental DisordersStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ginger E Nicol, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894738
- Sponsor's protocol ID
- 56790
- Status last verified
- Aug 2026
- First submitted
- 4 May 2009
- Last updated
- 20 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Cardiometabolic Risk in Children Treated With Antipsychotics: A Preliminary Study of Direct Measures
- ClinicalTrials.gov ID
- NCT00894738
- Acronym / sponsor ID
- 56790
- Conditions
- Mental Disorders
- Keywords
- pediatric, mental illness, antipsychotic, cardiometabolic risk, Antipsychotic agents, Mental disorders diagnosed in childhood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 7 May 2009 (estimated)
- Results
- Posted 6 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study aims to begin the multi-step process of establishing the reliability and validity of hepatic triglyceride content (HTGC) and carotid artery intima-media thickness (IMT) as biomarkers of cardiometablic risk in children treated for mental illness. The distribution of HTGC and carotid IMT-proximate indicators of cardiometabolic risk-across a range of dual-energy X-ray absorptiometry (DEXA)-measured adiposity in children treated with antipsychotic agents will be characterized in comparison to healthy, untreated, non-psychiatric controls, in order to estimate effect sizes for future studies incorporating these markers. The ability of HTGC and IMT to predict cardiometabolic risk as measured by commonly-used laboratory tests, such as fasting lipids, liver function tests, C-reactive protein and serum fibrinogen, will be assessed.
Detailed description
Carotid artery intima media wall thickness (IMT) is one of the most developed biomarkers of cardiometabolic risk, with established reliability and predictive validity, and has been utilized as a surrogate endpoint for cardiovascular disease progression in FDA-reviewed registration studies. This technique has also been used in children and adolescents without psychiatric disorders, indicating that changes in IMT are positively correlated with metabolic syndrome criteria. Magnetic Resonance Spectroscopy (1H MRS) to quantify hepatic triglyceride content (HTGC) is a promising new marker of cardiometabolic risk, especially given the importance of nocturnal circulating free fatty acids in the development of insulin resistance leading to type 2 diabetes. Fatty liver, related in part to obesity, is the most common liver abnormality found in children ages 2-19, with one in ten children manifesting signs of macrovascular steatohepatitis. 1H MRS is a well-established methodology used to measure HTGC that correlates well with liver biopsy results. This technique has been studied in obese children without psychiatric disorders, and is widely considered to be the optimal noninvasive means by which to measure HTGC. Unfortunately, neither of these promising methods have been applied to the study of cardiometabolic risk in children with psychiatric disorders.
It is important to now study these biomarkers in psychiatric populations, where individuals are subject to treatments that can increase risk. Our group is experienced in the application of sophisticated, gold standard techniques for measuring cardiometabolic risk in psychiatric populations, and is-to our knowledge-the only group in the US using sensitive methodologies like stable isotopomer euglycemic clamps to study the pathophysiology leading to diabetes and cardiovascular disease in the mentally ill. An important goal of studying these biomarkers is to ultimately determine which of the more commonly available conventional risk measures (e.g., lipid profiles, adiposity measures) can be used alone or in combination to accurately identify children at highest risk, to aid in the development and targeting of effective interventions.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antipsychotic treated | – | Procedure: Testing (MRS, US, DEXA, blood tests)Children with psychiatric diagnoses who are currently treated with antipsychotic medications. |
| healthy control | – | Procedure: Testing (MRS, US, DEXA, blood tests)Age- and gender-matched children who do not have a psychiatric diagnosis, are not taking antipsychotic medications, and are otherwise healthy. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children ages 6-18 who are currently being treated for a psychiatric condition with an antipsychotic medication, and age- and gender-matched healthy controls who are not treated with an antipsychotic medication.
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 |
|---|---|---|
| Testing (MRS, US, DEXA, blood tests)Magnetic Resonance Spectroscopy (MRS) of the liver to determine hepatic triglyceride content; ultrasound (US) of the carotid artery to determine intima-media thickness; dual energy X-ray absorptiometry (DEXA) to determine body composition; fasting lipids, fasting insulin, C-reactive protein, liver enzymes and fibrinogen levels. | Procedure or surgery | antipsychotic treated, healthy control |
Primary outcome
Carotid Artery Intima-media Thickness Measured by Ultrasonography.
Time frame: Week 1
Intrahepatic Triglyceride Content (IHTG) Measure by Liver Magnetic Resonance Spectroscopy.
Time frame: Week 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ginger E 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 Mental Disorders, 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?
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 20 Aug 2026. 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?
Yes. Results are posted in the registry (first posted 6 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Carotid Artery Intima-media Thickness Measured by Ultrasonography. (time frame: Week 1). The study lists 2 primary outcomes in all. 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 20 Aug 2026.