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CompletedNCT00894738Updated Aug 20, 2026Results posted

Measurement of Cardiometabolic Risk in Antipsychotic-Treated Children

An observational study in Mental Disorders, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 6 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Washington University School of Medicine · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
44
Ages
6 Years to 18 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Mental Disorders

Keywords

  • pediatric
  • mental illness
  • antipsychotic
  • cardiometabolic risk
  • Antipsychotic agents
  • Mental disorders diagnosed in childhood
03

In context

Mental Disorders

2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.

This study's enrollment of 44 is below the median of 200 across 480 observational studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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 criteria

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.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
44 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • antipsychotic treated

    Children with psychiatric diagnoses who are currently treated with antipsychotic medications.

    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.

    Procedure: Testing (MRS, US, DEXA, blood tests)

Interventions

  • ProcedureTesting (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.

06

What researchers measure

Primary outcomes

  1. Carotid Artery Intima-media Thickness Measured by Ultrasonography.

    Time frame: Week 1

  2. Intrahepatic Triglyceride Content (IHTG) Measure by Liver Magnetic Resonance Spectroscopy.

    Time frame: Week 1

07

Results

Posted Jun 6, 2019

Participant flow

Participant flow — Overall Study
MilestoneAntipsychotic-TreatedHealthy Control
Started2519
Completed2519
Not completed00

Outcome measures

PrimaryCarotid Artery Intima-media Thickness Measured by Ultrasonography.
Time frame:
Week 1
Reported as:
Mean · millimeters
Carotid Artery Intima-media Thickness Measured by Ultrasonography.
millimetersAntipsychotic-TreatedHealthy Control
Carotid Artery Intima-media Thickness Measured by Ultrasonography.0.508 ± 0.0530.519 ± 0.048
Statistical analysis
  • Antipsychotic-Treated vs Healthy Control · ANCOVA · p = 0.49 (The p-value listed is for DEXA total percent fat and is not adjusted for multiple comparisons. The alpha level was set to 5%.)
PrimaryIntrahepatic Triglyceride Content (IHTG) Measure by Liver Magnetic Resonance Spectroscopy.
Time frame:
Week 1
Reported as:
Mean · percent
Intrahepatic Triglyceride Content (IHTG) Measure by Liver Magnetic Resonance Spectroscopy.
percentAntipsychotic-TreatedHealthy Control
Intrahepatic Triglyceride Content (IHTG) Measure by Liver Magnetic Resonance Spectroscopy.2.48 ± 3.031.57 ± 1.37
Statistical analysis
  • Antipsychotic-Treated vs Healthy Control · ANCOVA · p = <0.0001 (The p-value listed is for DEXA total percent fat and is not adjusted for multiple comparisons. The alpha level was set to 5%.)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Antipsychotic-Treated———
Healthy Control———

Baseline characteristics

Age, Continuous
Age, Continuous(years)Antipsychotic-TreatedHealthy ControlTotal
Pre-pubertal status, ages 6-1110.3 ± 1.59.5 ± 1.69.9 ± 1.6
Post-pubertal status, age 12-1914.7 ± 1.715.3 ± 1.015.0 ± 1.4
Sex: Female, Male
Sex: Female, Male(Participants)Antipsychotic-TreatedHealthy ControlTotal
Female6410
Male191534
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Antipsychotic-TreatedHealthy ControlTotal
White91322
Not White16622
Body Mass Index (BMI) Percentile
Body Mass Index (BMI) Percentile(Percentile)Antipsychotic-TreatedHealthy ControlTotal
Mean67.5 ± 28.458.9 ± 30.263.8 ± 29.2
Blood Pressure
Blood Pressure(mm Hg)Antipsychotic-TreatedHealthy ControlTotal
Systolic111 ± 9112 ± 13111 ± 11
Diastolic69 ± 667 ± 868 ± 7
Dual Energy X-ray Absorptiometry (DEXA) Total Percent Fat
Dual Energy X-ray Absorptiometry (DEXA) Total Percent Fat(percent of total body fat)Antipsychotic-TreatedHealthy ControlTotal
Mean26.3 ± 11.124.1 ± 11.425.3 ± 11.2
Carotid Intima Media Thickness (CIMT)
Carotid Intima Media Thickness (CIMT)(mm)Antipsychotic-TreatedHealthy ControlTotal
Mean0.51 ± 0.050.52 ± 0.050.51 ± 0.05
Intrahepatic Triglyceride Content (IHTG)
Intrahepatic Triglyceride Content (IHTG)(percent of liver fat)Antipsychotic-TreatedHealthy ControlTotal
Mean2.5 ± 3.01.6 ± 1.42.1 ± 2.5

12 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
09

References and documents

Study documents

  • Informed consent form · Jan 21, 2021

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00894738
Lead sponsor
Washington University School of Medicine
Responsible party
Sponsor
First posted
May 7, 2009
Start date
Jan 1, 2010
Primary completion
Mar 31, 2016
Completion
Jun 1, 2016
Results posted
Jun 6, 2019
Last update
Aug 20, 2026

Study contacts

Ginger E Nicol, MD
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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