Advanced Discovery Research is looking for children and teens age 5-17 to participate in a study for irritability associated with autism. If your child qualifies, you may be compensated up to $1,143.00 for participation.
Living with autism can be challenging for children and teenagers. Some struggle to communicate what they are feeling or thinking in a way that can be easily understood by the people around them. This can lead to frustration and anger (“irritability”), which can be expressed as tantrums, aggression, yelling, and self-harming behavior.
This is a clinical research program including 2 identical studies which, together, are called the 601/602 Pediatric Autism Study.
The study will help us understand more about a potential new (investigational) medication (“study drug”) for irritability in children and teenagers with autism.
It is hoped that the study drug will:
- help restore the balance of chemicals in the brain (dopamine, serotonin, and glutamate) that are important for regulating mood, and
- reduce the severity of irritability and behaviors associated with it
About the Study:
The study drug will be compared with a placebo. A placebo looks like the study drug but does not contain any active ingredients. The placebo and study drug will both be called the “study drug.”
Your child will be randomly assigned to receive either a low dose, or a low dose followed by a higher dose of the study drug, or a placebo. You, your child, and the study doctor will not know what your child is receiving.
- The study drug comes as a capsule.
- Your child will take the study drug once a day for 6 weeks.
- The study will last for up to 2 months.
- Approximately 348 children and teenagers will take part in the study
Your child may qualify if:
- 5-17 years of age with a diagnosis of ASD
- experiencing irritability, such as tantrums, aggression, yelling, or self-harming behavior.
We are currently only looking for teenagers who are 13-17 years of age. Younger children will be invited to take part later.
- A group of doctors, nurses, and other medical staff (the study staff) will:
- explain the possible risks and benefits of the study
- carefully monitor the health of your child
- provide the study drug and study-related tests at no cost.
- You and your child will receive a stipend of up to $1,143.00 for participation in the study. Travel expenses may also be reimbursed.
- An Institutional Review Board (IRB)/Ethics Committee (EC) protects the rights, safety, and well-being of study participants. An IRB/EC has reviewed this study.
Taking Part in a Clinical Study:
Taking part in a clinical study is an important decision. Please ask any questions you or your child may have before deciding whether your child should take part. Study participation is voluntary. If you contact us, your child does not have to take part in the study.
About Clinical Studies
A clinical research study (sometimes also called a trial) is carefully overseen research that is done before a study medication becomes available to the public.
- Studies follow certain rules to protect the safety, rights, well-being, and privacy of participants.
- Studies are an important way to bring about new medical treatments to improve patient care.
It is up to you whether you would like your child to take part in the study, and you can change your mind about taking part at any time.
Deciding not to take part in the study or leaving the study after joining will not affect your child’s usual medical care, either now or in the future.
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