A 6-week, randomized, parallel, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of Lurasidone in children and adolescent subjects with irritability associated with autistic disorder.
The use of lurasidone, the study drug, is approved for the treatment of some conditions in adults, but for the treatment of children with autistic disorder, it is considered experimental. It is being studied because it has not been approved by the FDA for the treatment of autistic related irritability in children and adolescents.
The purpose of this research study is to evaluate the safety and effectiveness of two different doses of study drug compared to a placebo for use in children and adolescents with irritability associated with autistic disorder. Children can participate in this clinical trial for up to 10 weeks.
- Male and females ages 6-17
- Have been diagnosed as having Autistic Disorder with associated irritability (i.e. aggression, tantrums, rapidly changing moods, self-injurious behavior)
Anita Kablinger, MD
Clinical Research Coordinator
Email: firstname.lastname@example.org