A new study shows the drug significantly improved autism-related irritability symptoms, such as aggression, tantrums, rapidly changing moods, and self-injurious behavior after eight weeks of treatment.
Researcher Randall Owen, MD of Bristol-Myers Squibb in Wallingford, Conn., which makes Abilify, and colleagues say irritability is a common symptom of autism and is often difficult to manage.
Abilify was recently approved by the FDA for the treatment of irritability related to autistic disorder in children and adolescents. Risperdal (risperidone) is also approved by the FDA for this indication.
In the study, published in Pediatrics, researchers examined the short-term safety and effectiveness of Abilify in treating irritability symptoms in a group of 98 children and adolescents (aged 6-17 years) with autism. They were randomly divided into groups that took Abilify or a placebo for eight weeks.
The results showed that by week eight of the study 52% of those taking Abilify experienced a 25% or greater improvement in autism-related irritability symptoms compared with 14% of those who took the placebo.
No serious side effects were associated with use of the drug. Most side effects were mild to moderate in severity and included fatigue, sleepiness, vomiting, and increased appetite. The average weight gain among those taking Abilify was 4.4 pounds compared with 1.8 pounds among those who took the placebo.
Researchers say additional studies are needed to look at the long-term effects of using Abilify to treat irritability in children with autism and to compare the effectiveness and safety of the drug vs. other medications.