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DGReview
No Increase In Side Effects From Methylphenidate In Children With Attention Deficit Hyperactivity Disorder And Mania
A DGReview of :"Response to methylphenidate in children with attention deficit hyperactivity disorder and manic symptoms in the multimodal treatment study of children with attention deficit hyperactivity disorder titration trial"
Journal of Child and Adolescent Psychopharmacology
08/07/2003
By Guy Furness
The presence of mania in children with attention deficit hyperactivity disorder (ADHD) is not associated with an increase in side effects from methylphenidate, compared with children without mania. Clinicians should not therefore avoid stimulants in such children, researchers advise.
The 1-month titration study, which was led by Cathryn Galanter, MD, of Columbia University, New York, United States, involved a subset of 270 children (aged 7 to 9.9 years) from another trial - the multimodal treatment study of children with ADHD (see related studies below) - who participated in a placebo-controlled, double-blind titration. After a lead-in, the children received 1 of 3 doses of methylphenidate or placebo for 28 days in a randomised, crossover daily-switching, double blind protocol.
Symptoms of ADHD were measured using several methods. Parents and teachers rated the presence and severity of 10 adverse-effects commonly associated with methylphenidate. Two proxies were constructed to capture children with some manic symptoms but who did not have bipolar disorder.
Twenty-nine (10%) of subjects had the first proxy, known as the DISC-mania proxy, which was based on the mania section of the diagnostic interview schedule for children (version 2.3). The other proxy was based on a response pattern on child behavioural checklist T scores and known as the CBCL mania proxy. There were 32 subjects (11.1%) with the CBCL mania proxy and 7 children had both proxies. The researchers noted that the degree of agreement between the proxy measures was low.
Although 4 children were removed from the study during the lead-in phase due to prohibitive side effects, there was no association of either proxy group with removal during lead-in. No children were removed during the titration period due to prohibitive side effects.
During the titration period, children in either mania proxy group responded similarly, with respect to side effects, to the non-proxy groups. "They did not have more irritability or more adverse effects in response to stimulants and were not more likely to discontinue medication due to side effects," the researchers said. They noted that the children in the DISC mania proxy group had a significant decrease in parent-reported worry, compared with those not in that group.
In conclusion the researchers said: "Children with ADHD and manic symptoms may benefit from a carefully monitored methylphenidate trial." They highlighted a need for studies assessing the response to stimulants over a longer period - the group plans to conduct such investigations in the future.
Related studies:
Arnold LE et al: NIMH collaborative multimodal treatment study of children with ADHD (MTA): Design, methodology, and protocol evolution. J Atten Disord 2(3):141-158, 1997.
Arnold LE et al: NIMH Collaborative Multimodal Treatment Study of Children With ADHD (MTA): Design challenges and choices. Arch Gen Psychiatry 54:865-870, 1997.
MTA Cooperative Group: A 14-month randomized clinical trial of treatment strategies for attentiondeficit/hyperactivity disorder. Arch Gen Psychiatry 56:1073-1086, 1999.
J Child Adolescent Psychopharmacol 2003;13:2:123-36.
"Response to methylphenidate in children with attention deficit hyperactivity disorder and manic symptoms in the multimodal treatment study of children with attention deficit hyperactivity disorder titration trial"
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