01-05-2006, 08:22 PM
Ritalin can be effective for control of hyperactivity
Archives of General Psychiatry
NewsRx.com - January 05, 2006
Ritalin (methylphenidate) treatment can be an effective means of controlling hyperactivity in children with pervasive developmental disorders.
"Hyperactivity and inattention are common symptoms in children with autistic disorder and related pervasive developmental disorders, but studies of stimulants in these conditions have been inconclusive," according to physicians in Indianapolis, who examined the "efficacy and safety of methylphenidate hydrochloride in children with pervasive developmental disorders and hyperactivity."
The study design was a "double-blind, placebo-controlled, crossover trial followed by open-label continuation," explained M.G. Aman and coauthors working at the James Whitcomb Riley Hospital for Children. "Seventy-two drug-free children, aged 5-14 years, with pervasive developmental disorders accompanied by moderate to severe hyperactivity" were enrolled.
"Prior to randomization, subjects entered a 1-week test-dose phase in which each subject received placebo for 1 day followed by increasing doses of methylphenidate (low, medium, and high doses) that were each given for 2 days," the investigators said. "The low, medium, and high doses of methylphenidate hydrochloride were based on weight, and they ranged from 7.5 mg/d to 50.0 mg/d in divided doses."
"Subjects who tolerated the test dose (nf) were assigned to receive placebo for 1 week and then 3 methylphenidate doses in random order during a double-blind, crossover phase," according to the trial report. "Children responding to methylphenidate then entered 8 weeks of open-label treatment at the individually determined best dose."
"The primary outcome measure was the teacher-rated hyperactivity subscale of the Aberrant Behavior Checklist," Aman and collaborators noted. "Response was defined as 'much improved' or 'very much-improved' on the Clinical Global Impressions Improvement item coupled with considerable reductions in the parent-rated and/or teacher-rated Aberrant Behavior Checklist hyperactivity subscale score."
"Methylphenidate was superior to placebo on the primary outcome measure, with effect sizes ranging from 0.20 to 0.54 depending on dose and rater," published data showed. "Thirty-five (49%) of 72 enrolled subjects were classified as methylphenidate responders," while "adverse effects led to the discontinuation of study medication in 13 (18%) of 72 subjects."
"Methylphenidate was often efficacious in treating hyperactivity associated with pervasive developmental disorders, but the magnitude of response was less than that seen in typically developing children with attention-deficit/hyperactivity disorder," and "adverse effects were more frequent," the researchers concluded.
Aman and colleagues published their study in the Archives of General Psychiatry (Randomized, controlled, crossover trial of methylphenidate in pervasive developmental disorders with hyperactivity. Arch Gen Psychiatry, 2005;62(11):1266-1274).
For additional information, contact D.J. Posey, James Whitcomb Riley Hospital for Children, Room 4300, 702 Barnhill Dr., Indianapolis, IN 46202, USA.
Publisher contact information for the journal Archives of General Psychiatry is: American Medical Association, 515 North State St., Chicago, IL 60610-0946, USA.
Archives of General Psychiatry
NewsRx.com - January 05, 2006
Ritalin (methylphenidate) treatment can be an effective means of controlling hyperactivity in children with pervasive developmental disorders.
"Hyperactivity and inattention are common symptoms in children with autistic disorder and related pervasive developmental disorders, but studies of stimulants in these conditions have been inconclusive," according to physicians in Indianapolis, who examined the "efficacy and safety of methylphenidate hydrochloride in children with pervasive developmental disorders and hyperactivity."
The study design was a "double-blind, placebo-controlled, crossover trial followed by open-label continuation," explained M.G. Aman and coauthors working at the James Whitcomb Riley Hospital for Children. "Seventy-two drug-free children, aged 5-14 years, with pervasive developmental disorders accompanied by moderate to severe hyperactivity" were enrolled.
"Prior to randomization, subjects entered a 1-week test-dose phase in which each subject received placebo for 1 day followed by increasing doses of methylphenidate (low, medium, and high doses) that were each given for 2 days," the investigators said. "The low, medium, and high doses of methylphenidate hydrochloride were based on weight, and they ranged from 7.5 mg/d to 50.0 mg/d in divided doses."
"Subjects who tolerated the test dose (nf) were assigned to receive placebo for 1 week and then 3 methylphenidate doses in random order during a double-blind, crossover phase," according to the trial report. "Children responding to methylphenidate then entered 8 weeks of open-label treatment at the individually determined best dose."
"The primary outcome measure was the teacher-rated hyperactivity subscale of the Aberrant Behavior Checklist," Aman and collaborators noted. "Response was defined as 'much improved' or 'very much-improved' on the Clinical Global Impressions Improvement item coupled with considerable reductions in the parent-rated and/or teacher-rated Aberrant Behavior Checklist hyperactivity subscale score."
"Methylphenidate was superior to placebo on the primary outcome measure, with effect sizes ranging from 0.20 to 0.54 depending on dose and rater," published data showed. "Thirty-five (49%) of 72 enrolled subjects were classified as methylphenidate responders," while "adverse effects led to the discontinuation of study medication in 13 (18%) of 72 subjects."
"Methylphenidate was often efficacious in treating hyperactivity associated with pervasive developmental disorders, but the magnitude of response was less than that seen in typically developing children with attention-deficit/hyperactivity disorder," and "adverse effects were more frequent," the researchers concluded.
Aman and colleagues published their study in the Archives of General Psychiatry (Randomized, controlled, crossover trial of methylphenidate in pervasive developmental disorders with hyperactivity. Arch Gen Psychiatry, 2005;62(11):1266-1274).
For additional information, contact D.J. Posey, James Whitcomb Riley Hospital for Children, Room 4300, 702 Barnhill Dr., Indianapolis, IN 46202, USA.
Publisher contact information for the journal Archives of General Psychiatry is: American Medical Association, 515 North State St., Chicago, IL 60610-0946, USA.