A window into young hearts: new biomarkers may spot antipsychotic side effects early

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.