(Great Neck, N.Y. - June 12, 2009) — A drug commonly given to children with autism to reduce repetitive behaviors is ineffective compared to placebo, and in some children may actually increase repetitive behaviors. The finding comes from the largest study of autistic children to date, conducted at six academic medical centers, and reported in the June 29, 2009 issue of Archives of General Psychiatry.
“What we found, much to our surprise, is that there was no significant difference in positive response between kids treated with citalopram and kids who received the placebo. And the kids treated with citalopram tended to have more side effects,” said NARSAD 2000 Young Investigator Linmarie Sikich, M.D., a co-author of the study and associate professor of psychiatry at the University of North Carolina at Chapel Hill School of Medicine. “I cannot emphasize this enough: This was not at all what we expected to see,” she said.
Citalopram, sold under the brand name Celexa, is one of a class of antidepressant drugs called selective serotonin reuptake inhibitors, or SSRIs, which are the most frequently used medications for children with autism. They are also used to treat depression, anxiety and obsessive compulsive disorder in both adults and children. Before this study, there was very little scientific evidence to support the use of SSRIs in children with autism, but some preliminary studies showed promising results for citalopram, Dr. Sikich said.
Hypothesizing that citalopram would improve the overall functioning of autistic children and adolescents by reducing repetitive behavior, Dr. Sikich and colleagues recruited 149 children ages 5 to 17 to take part in the 12-week trial, during which 73 received daily doses of liquid citalopram, while 76 received daily doses of liquid placebo. Researchers measured the children’s response to treatment using the Clinical Global Impression-Improvement scale (CGI-I). They also recorded measures of repetitive behavior and side effects.
At the end of the trial, some children in both groups showed a positive response. However, there was no significant difference between the groups: the positive response in the citalopram group was 32.9 percent versus 34.2 percent in the placebo group. In addition, children in the citalopram group were significantly more likely to experience adverse side effects, such as increased energy level, impulsiveness, decreased concentration, hyperactivity, increased repetitive movements and behaviors, diarrhea, insomnia and dry, itchy skin.
The researchers concluded that citalopram “is not an effective treatment” for autistic children with repetitive behaviors. In addition, they wrote, this trial shows that the use of SSRIs in autistic children “is not without risk” and “at present, there is insufficient research evidence to merit a clear recommendation regarding the use of SSRIs as a class” for the treatment of repetitive behavior in children with autism spectrum disorders.
“The obvious short-term message is, this treatment didn’t work. And that surprised us a great deal,” Dr. Sikich reiterated. “But the really important take-home message is that we have to do large, scientifically-sound comparative studies like this to really know whether a specific treatment works and is safe. Simply relying on doctors’ and families’ impressions often leads us to use medications that really don’t work and may do more harm than good,” she said, and added that safe and effective medication and behavioral treatments are desperately needed to help children with autism realize their potentials and keep from harming themselves or others.
“Well-done studies, using methods like the ones in this study, have shown that another drug, risperidone, is useful in reducing irritability and aggression in children with autism,” she said. “Thus, this study shouldn’t be interpreted as saying all medications don’t help people with autism and are harmful. Instead it says that citalopram doesn’t help most children with autism and is harmful to some children. Clearly we need more research to develop and test other interventions for this important problem.”
People with autism experience major problems with repetitive behaviors, often including self-injurious behaviors. The behaviors often keep autistic children from learning or participating in age- appropriate activities. When it is necessary to stop the behavior, many become distraught and aggressive. These behaviors also contribute to the difficulties adults with autism have in living independently or working, Dr. Sikich said.
The study, funded by the National Institutes of Health, took place at the University of North Carolina at Chapel Hill, Mount Sinai School of Medicine, the North Shore-Long Island Jewish Health System, Dartmouth College, the University of California, Los Angeles and Yale University. Principal investigator and lead author was Bryan H. King, M.D., of the University of Washington and director of psychiatry and behavioral medicine at Seattle Children’s Hospital, who began his involvement while at Dartmouth.
(This article was adapted with permission from the University of North Carolina at Chapel Hill School of Medicine).
Link to article: http://www.narsad.org/news/press/rg_2009/res2009-06-12.html