The ADHD Clinical Research Studies

About the Studies

Multiple clinical research studies are being conducted for younger children with ADHD. Children who show symptoms of ADHD such as increased levels of inattentiveness, hyperactivity, or impulsiveness, and are ages 4 or 5, may be eligible to participate in one of the studies.

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These clinical research studies are examining two different investigational drugs, lisdexamfetamine dimesylate (also called SPD489) and “mixed salts of a single entity amphetamine product” (also called SHP465), in varying doses, to determine if they are safe and effective for children, ages 4 or 5, with ADHD.

Lisdexamfetamine dimesylate (SPD489) has only been approved by the FDA to treat ADHD in adults and children who are 6 years of age and older. It has not been approved for the treatment of children with ADHD who are younger than 6 years of age, so it is considered an investigational drug in these studies.

“Mixed salts of a single entity amphetamine product” (SHP465) has been approved by the FDA to treat ADHD in adults and children who are 13 years of age and older. It has not been approved for the treatment of children with ADHD who are younger than 13 years of age, so it is considered an investigational drug in these studies.

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Children who participate in one of these clinical research studies may receive one of the investigational drugs or placebo. A placebo looks like the investigational drug but contains no active ingredients. If your child participates, a study doctor who is a medically qualified physician will be responsible for overseeing your child’s care during the study. The study doctor will coordinate your child’s care with other study team members including nurses, study coordinators, mental health professionals, and others, all of whom have expertise in pediatrics and research.

Those children who complete one of these clinical research studies may have the opportunity to participate in an extension study in which all participants will receive one of the study drugs for up to one year.

To learn if these studies are available in your area, click the button below.

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