The use of antipsychotics in young children is declining but doctors continue to prescribe these medications off-label for conditions not approved by the Food and Drug Administration and without the recommended psychiatric consultation, a Rutgers study found.

The study, published in the Journal of the American Academy of Child and Adolescent Psychiatry, looked at 301,311 antipsychotic prescriptions filled by privately insured children ages 2 to 7 in the United States from 2007 to 2017.

While results are encouraging that antipsychotic prescribing declined in recent years, the researchers noted that they continued to be prescribed for conditions lacking safety and effectiveness data such as conduct disorder, ADHD, anxiety and depression.

“We lack information on the effectiveness and safety of antipsychotics for treating those conditions in young children,” said lead author Greta Bushnell, a member of the Rutgers Institute for Health, Health Care Policy and Aging Research and an assistant professor at Rutgers School of Public Health. “Guidelines recommend that psychosocial services are used before antipsychotic treatment and that children are carefully assessed before initiating antipsychotics. However, fewer than half of the children receiving antipsychotic treatment in our study had a visit with a psychiatrist or a psychotherapy claim.”

Pervasive developmental disorders (PDD) — characterized by delays in the development of socialization and communication skills — accounted for the most antipsychotic prescribing in recent years.

“While there is some evidence supporting the use of antipsychotics in young children with PDD or intellectual disabilities, antipsychotics are not FDA approved for conduct disorders or ADHD,” said Bushnell. “Despite continued prescribing, there is limited evidence for the efficacy of antipsychotics for conduct or disruptive behavior disorders in very young children and the long-term outcomes remain poorly understood.”

In addition, the study found that antipsychotics were more often prescribed to boys, especially between ages 6 and 7, and that most of the children receiving antipsychotics also filled a prescription for another class of psychotropic medications, such as stimulants, clonidine or guanfacine for managing ADHD symptoms, and antidepressants.

Children who take antipsychotic medication are at risk of weight gain, sedation, diabetes, high cholesterol, cardiovascular disease and unexpected death. In very young children, antipsychotics might cause developmental and other long-term adverse effects. “The low rate of use of safer first-line psychosocial treatments, such as parent-child interaction therapy or cognitive-behavioral therapy, potentially puts children at unnecessary risks associated with antipsychotic treatment,” Bushnell said. The study was co-authored by Stephen Crystal at the Rutgers Institute for Health, Health Care Policy and Aging Research.