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NCT00894738

Biomarkers of Cardiometabolic Risk in Children Treated With Antipsychotics: A Preliminary Study of Direct Measures

Completed Results posted Last updated 6 June 2019
What this trial tests

trial testing Testing (MRS, US, DEXA, blood tests) in Mental Disorders in 44 participants. Completed in 1 June 2016.

Timeline
1 January 2010
Primary endpoint
31 March 2016
1 June 2016

Quick facts

Lead sponsorWashington University School of Medicine
StatusCompleted
Study typeOBSERVATIONAL
Enrollment44
Start date1 January 2010
Primary completion31 March 2016
Estimated completion1 June 2016
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Washington University School of Medicine

Who can join

Adults 6 to 18, any sex, with Mental Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Carotid Artery Intima-media Thickness Measured by Ultrasonography. Primary · Week 1
GroupValue95% CI
Antipsychotic-Treated0.508± 0.053
Healthy Control0.519± 0.048
Intrahepatic Triglyceride Content (IHTG) Measure by Liver Magnetic Resonance Spectroscopy. Primary · Week 1
GroupValue95% CI
Antipsychotic-Treated2.48± 3.03
Healthy Control1.57± 1.37

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Adiposity and Cardiometabolic Risk in Children With and Without Antipsychotic Drug Treatment.
    Nicol GE, de las Fuentes L, Riek AE, Bernal-Mizrachi C, et al · · 2015 · cited 1× · PMID 26186300 · DOI 10.1210/jc.2015-2119

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Other recruiting trials for Mental Disorders

Currently open trials in the same condition.

Other Washington University School of Medicine trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00894738.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing