Who can participate?
Children, teens and adults 12 to 25 years old who:
- Have a diagnosis of autism, Asperger’s disorder (not associated with
Fragile X Syndrome or other known cause) or pervasive developmental disorder
not otherwise specified
- Suffer from
symptoms of significant irritability
- Have a history of treatment with medications for
irritability that have not been effective
- Weigh at least 110 pounds
What will happen in the study?
You or your child will take part in this research study for about 14
weeks and complete 7 study visits.
You or your child will be "randomized"
into 1 of 2 study groups. Randomization means that your child will be put into
a study group completely by chance, like flipping a coin. You or your child
will have an equal chance of being placed either group. Each participant in the
study will receive 5 weeks of treatment with the study drug and 5 weeks of
treatment with placebo, with a 2 week wash-out period between treatment arms.
You or your child will be randomized into a group that receives either study
medication or placebo first. Neither you, your child, nor the researcher
conducting this study will know what group your child will be in.
During the study, your child will be complete some tests and
- Review of medical and medication history
- Physical exam (height, weight, temperature, pulse,
and blood pressure)
- Electrocardiogram or ECG (a painless test of the heart’s rhythm)
to diagnosis autism (if needed)
- Blood draw
- Questions about you or your child’s symptoms,
behavior and changes you may observe
- Weekly phone calls with the study staff
A detailed list of procedures will be provided to anyone interested in
knowing more about this study.