Clinical Trials / Research Studies
Attention-Deficit/Hyperactivity Disorder (ADHD) Study for Children 4 to 5 Years Old
Why are we doing this research?
Cincinnati Children's is conducting a research study, sometimes known as a clinical trial or clinical study, to learn more about the efficacy and safety of a study drug called SPN-812 in children with Attention-Deficit/Hyperactivity Disorder (ADHD).
Who can participate?
Children 4 to 5 years old who have been diagnosed with ADHD may be eligible to participate.
Conditions
- ADD / ADHD
What will happen in the study?
You and your child will be asked to visit Cincinnati Children's for 8 study visits over an 8-week period. These are the things that may happen to your child while in the study:
You may be asked:
- To complete questionnaires and assessments of ADHD symptoms and overall health
- To complete a physical examination and vital signs
- For a blood sample
- For a urine sample
- To undergo an electrocardiogram (ECG)
You and your child will be given a consent form that thoroughly explains all the details of the study. A member of the study staff will review the consent form with you and will be sure that all your questions are answered. The consent form will also outline any potential placebo use, as the study compares SPN-812 to placebo.
What are the good things that can happen from this research?
If you agree to take part in this study, there may not be direct medical benefits to your child. However, this study may improve understanding of ADHD in young children and may lead to better treatments in the future
What are the bad things that can happen from this research?
There may be some risks and discomforts from being in the study which will be discussed with you. Common risks may include side effects from the study drug, blood draws, or ECG procedures, which will be fully explained. If you choose, you can discuss these risks with your regular health care provider or with the study doctor.
Will you/your child be paid to be in this research study?
Participants may receive up to $675 for their time and effort.
Contact
ADHDResearch@cchmc.org
513-636-9769
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039
Study Doctor
Craig Erickson
Division of Child Psychiatry
Cincinnati Children’s Hospital Medical Center
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3333 Burnet Avenue, Cincinnati, Ohio 45229-3026
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