ADHD (Attention Deficit Hyperactivity Disorder) - Midlothian VA

Summary:

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Centanafadine is a non-stimulant, triple reuptake inhibitor that modulates norepinephrine, dopamine and serotonin reuptake with the intent of improving focus, attention, and specific higher level cognitive skills in patients with ADHD. Two phase II clinical trials in adults, including a phase IIb trial, have been completed for centanafadine, setting the stage for the start of phase III trials in ADHD.

It can take up to 28 days for your study doctor to confirm you are eligible to join the study.  Everyone in this study will get centanafadine and/or placebo (a pill without active medicine, sometimes called a “sugar pill”).  In this informed consent, centanafadine and placebo will be referred to as “study drug.” Once you are assigned to a study treatment, you will remain on that treatment for the whole treatment period of 49 days. Out of approximately 450 people:

·         Approximately 150 will receive centanafadine SR 200mg

·         Approximately 150 will receive centanafadine SR 400mg

·         Approximately 150 will receive placebo

Qualified Participants Must:

• Be between the ages of 18 and 55 years
• Have a current diagnosis ADHD

Qualified Participants May Receive:

WHAT ARE THE POSSIBLE BENEFITS FOR ME?

You may or may not benefit from your participation in this study.  If you receive centanafadine and it is effective for you, your symptoms of ADHD may improve while you take part in this study. Even if you do not personally benefit from the study, your participation may help increase knowledge about ADHD and how centanafadine may help others in the future. 

ARE THERE ANY COSTS?

There is no cost to you for receiving centanafadine or placebo or any study related tests and procedures during the course of this study.

You do not have to pay to be in this study.

WILL I BE PAID TO TAKE PART?

You may be reimbursed up to $65 to cover costs associated with study participation including transportation to/from the study site, data usage, etc.  If you do not complete all study requirements, the amount will be prorated based upon the portion of study participation.  Please ask your study doctor for details. Please refer to the attached Participant Information Sheet if you would like more details on what will happen if you take part in this study.