Lessons learnt in conducting a clinical drug trial in children with Asperger Syndrome.
OBJECTIVE
To describe the authors' experience of conducting a clinical drug trial in children with Asperger Syndrome, including the pitfalls encountered and lessons learnt.


CONCLUSIONS
The main barrier encountered was in the recruitment of children: it was not possible to recruit the target of 60 patients. The recruitment of children is often the major barrier to the progress of a successful clinical trial. Conducting the clinical drug trial was greatly facilitated by the appropriate setting and experienced clinical pharmacology staff.
Mathai
John
J
Child and Adolescent Psychiatrist, Royal Children's Hospital, Mental Health Service, Parkville, Vic., Australia. john.mathai@rch.org.au
Bourne
Angela
A
Cranswick
Noel
N
D000293:Adolescent; D000328:Adult; D020817:Asperger Syndrome / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D002648:Child; D002665:Child Psychiatry; D004311:Double-Blind Method; D006801:Humans; D010348:Patient Care Team / Q000458:organization & administration; D018579:Patient Selection; D010601:Pharmacology, Clinical; D010919:Placebos; D011569:Psychiatric Status Rating Scales; D012107:Research Design / Q000592:standards; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D020280:Sertraline / Q000627:therapeutic use*; D016896:Treatment Outcome
D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline