Autism Therapies on Trial
words by eve jacobs /
photograph by john emerson
utism’s winter is slowly giving way to spring with research into novel therapies building a steadily increasing foundation of scientific data. Even though a combination of education, behavioral therapies, and medications that diminish symptoms are what’s available right now, researchers are looking for a “breakthrough” treatment — one that could revolutionize care and maybe even head-off symptoms in siblings of children diagnosed with the disorder. The number of clinical trials enrolling kids with autism spectrum disorders is growing, a truly positive sign. A search on ClinicalTrials.gov, a Website listing NIH-supported trials, turns up 140 clinical studies on autism, with 71 of these currently open to new participants.
Fish oil has been in the headlines recently with claims of its benefits ranging from pain relief to improved brain function to decreased depression. Several research studies have been done, showing evidence that fish oil can lower triglycerides, slow atherosclerotic plaque build-up, lower blood pressure slightly, and reduce the risk of stroke and heart attack in people with heart disease. Fish oil appears to act by counteracting oxidative stress, thereby reducing chronic inflammation and its deleterious effects on the body.
If inflammation is causing havoc in the brains of children with autism, might fish oil prove to be a “breakthrough” therapy? Sherie Novotny, MD, associate professor of child and adolescent psychiatry at UMDNJ’s Robert Wood Johnson Medical School (RWJMS) and University Behavioral HealthCare, would like to answer that question.
Omega three fatty acids — key components of fish oil — have already shown promise as an adjunct therapy for bipolar disorder and schizophrenia. Novotny is looking at the possibility that fish oil can lessen aggression and depression in kids with autism spectrum disorder. “William Johnson is looking at the genetic aspects of fatty acid metabolism — the oxidative stress aspect — and I’m looking at the behavioral aspects of fatty acid metabolism,” she explains. Johnson is a professor of neurology and a neurogenetics researcher at RWJMS and a member of the team that identified two Parkinson’s genes, one of them the first Parkinson’s gene ever to be discovered.
“Our group has identified three antioxidant polymorphic genetic variants associated with autism,” says Johnson. The altered genes may be less able to combat oxidative stress.
Novotny says the time commitment for a child to participate in this study is demanding, with the initial evaluation taking four to five hours, although it can be broken down into a couple of sessions. That is followed by a half hour session for four consecutive weeks, a half hour every other week for four weeks, and a
one- to-two hour ending session. The child may simultaneously continue any other psychotropic medicines that he is already taking, if no change to the medication is made, since the trial is looking at fish oil as an adjunct therapy. At the study’s end, the family will decide if the child will be weaned off or continue taking the fish oil.
A complementary study, funded by the Department of Defense, will look at how a component of Docosahexaenoic acid (DHA), a key omega-3 fatty acid, affects behavior in those with autism spectrum disorders. Small studies have suggested some improvement in symptoms and a decrease in irritability in kids with autism who are treated with DHA.
Novotny will try to recruit 60 children who are not on psychotropic medication to participate. “This will be the largest study of its kind so far,” she says.
The child psychiatrist is also looking at new uses for two drugs that are already prescribed for other conditions. Irritability and aggression can be major destructive forces in a child’s life. This eight-week study looks at the drug aripiprazole, approved by the FDA for schizophrenia and bipolar disorder, comparing it to placebo. Twenty participants will be enrolled by the end of June.
The other is a 12-week study of a mood stabilizer called oxcarbazepine. “Kids with autism frequently have mood swings,” says Novotny. This drug is approved for severe mood swings in bipolar children and adults, but has not yet been tried for autism.
The child psychiatrist spends about 60 percent of her workday on clinical trials, 40 percent on patient care. She is intent on finding that breakthrough therapy.
“I would like to give DHA to kids younger than 5, maybe even in baby formula. We could potentially head-off symptoms of autism in young children where autism has already affected a child in the family.
“We take very good care of our patients, during the studies and after. We help them in any way we can. Parents need to be involved to get the research process moving more quickly. We appreciate all of their extra effors — to help their own child and all children diagnosed with autism.”