| Here are some details on a National Institute of Mental
Health study, launched in 2001, which is designed to help
determine if Ritalin is effective, and safe, for very young
children. Although very little is known about the short- or
long-term effects of stimulant medications on this age group,
prescription rates for them are rising dramatically. |
|
Ritalin and Preschoolers
In February 2000, University of Maryland researcher Julie Magno Zito
published a report in the Journal of the American Medical Association which
found that psychotropic medications such as
Ritalin and
Adderall were being
prescribed to preschoolers at alarmingly high rates, especially considering
that many of the drugs have not been approved by the FDA for use in children
under 6, and there's little research about their effects on young children. Zito examined data from two state Medicaid programs and a health maintenance
organization, and found that as many as 1.5 percent of children between the
ages of 2 and 4 were being prescribed stimulants, anti-depressants, or
anti-psychotic drugs. The findings suggested that prescription rates had
increased as much as 50 percent between 1990 and 1995. Although the study
did not identify which conditions the children were being treated for, in
the Washington Post, Zito said she believed that the rise in prescription
rates for very young children was definitely related to the recent national
increase in Ritalin prescriptions for school-aged children.
The Preschool ADHD Treatment Study
Zito's report drew strong media coverage and also attracted the attention
of Hillary Clinton, who embarked on a campaign to learn more about the
effects of drugs like Ritalin on preschoolers. Subsequently, the National
Institute of Mental Health gave $6 million to a consortium of six
institutions, led by Dr. Laurence Greenhill of Columbia University, to
conduct a five-stage, 40-week study on Ritalin use in preschoolers. This is
the first extensive study to be done on this issue.
The Preschool ADHD Treatment Study (PATS) will examine dosing issues,
side effects questions, and the efficacy of Ritalin in preschool aged
children. As of April 2001, the recruitment of children into the study is
underway at the six sites across the country. The effort is to find out how
well children ages 3-6 do on a trial of methylphenidate in the short term
and over the relative long term (1 year). In order to compare how Ritalin
affects younger children to older children, the study will also recruit
subjects between 6 and 8 years old.
Some critics have expressed concerns about the recruitment process,
saying that it may be hard to diagnose ADHD in such young children. Dr.
Howard Abikoff, who is heading up the study at one of the sites at the NYU
Child Study Center, says those concerns, while valid, have been addressed by
the design of the study. Subjects are required to show persistent symptoms
of ADHD for 9 months, rather than the 6 months required by the DSM-IV
criteria. Subjects must be attending a school-type setting, and data must be
gathered from a teacher or professional in that setting, rather than parents
alone. And finally, before a subject is approved for the study, the parents
undergo a 10-week training in behavioral therapy specifically designed for
parents young kids with ADHD. The child is then reevaluated, and if he or
she no longer meets the criteria, will not be considered for the study. "We
are not interested in putting children on medication for whom there is not
an obvious need," Abikoff said.
The study is designed in the hopes that the resulting data will be
extensive enough to meet the FDA requirements for making a ruling as to
whether Ritalin is appropriate and safe for use in young children. The
researchers are planning to follow up with the subjects of the study over
the long term, in order to see how the children treated with Ritalin early
in life fare as they grow older.
next: Rundown of ADHD Drugs
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Written 2001. Reviewed: 02/2006
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