Affiliations: Department of Preventive Medicine & Community
Health, New Jersey Medical School-UMDNJ Newark, NJ, USA | Department of Neurology, New Jersey Medical
School-UMDNJ, Newark, NJ, USA
Note: [] Correspondence: Dr. Michael B. Brimacombe, Department of
Preventive Medicine and Community Health, New Jersey Medical School – UMDNJ,
185 South Orange Ave., PO Box 1709, Newark, NJ 07101-1709, USA. E-mail:
brimacmb@umdnj.edu
Abstract: The overall design quality of studies conducted on psychotropic
substances prescribed to autism spectrum disorder and attention deficit
hyperactivity disorder children is reviewed. Searches were conducted on Medline
and Cochrane Controlled Trials Register. Peer-reviewed, published studies,
written in English were included. Only studies that focused on children, had a
minimal sample size of ten participants, and were conducted between 1994 and
2004 were included in the review. Two hundred and eighty one studies were
identified and reviewed with 184 (65.5%) focused primarily on
methylphenidate, with the remaining 97 studies examined stimulants,
antipsychotics, antidepressants, alpha agonists, anxiolytics, and mood
stabilizers. Of these, 152 (54.1%) did not employ optimal double blind
placebo controlled design and 106 (37.7%) were conducted with less than 30
participants. The upper quartile for median study duration across all
medications examined was 9.75 weeks for double-blinded studies and 16 weeks for
all studies. Many pharmacotherapy studies conducted on children with autism
spectrum disorder and attention deficit hyperactivity disorder are of limited
duration, weak quality design and may be seriously underpowered. The issue of
follow-up is rarely adequately addressed. These findings raise both safety and
efficacy questions that have yet to be adequately studied.
