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Effectiveness of Combined Medication Treatment for Aggression in Children With Attention Deficit With Hyperactivity Disorder (The SPICY Study)
A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)
What is ADHD?
ADHD stands for attention deficit hyperactivity disorder, a neurodevelopmental condition that affects the brain's ability to manage attention, impulse control, and planning. It starts in childhood: about 1 in 9 US children have a current diagnosis. But it doesn't stop there. Around 15.5 million US adults live with ADHD, and more than half only found out as adults.
ADHD research has some unusual challenges. Nearly every stimulant on the market comes from just two base medicines, so researchers are now focusing on nonstimulants instead. People in ADHD studies also tend to improve on placebo, which makes results harder to read. And adults, especially women, were overlooked by research for decades, so many studies now recruit them on purpose.
What is the difference between ADD and ADHD?
There is no real difference: ADD is an outdated name for the same condition. Doctors adopted ADD in 1980 and replaced it with ADHD in 1987. The current diagnostic manual does not list ADD at all. What people used to call ADD was attention problems without the hyperactive part. Today that is closest to what doctors call the predominantly inattentive presentation of ADHD.
Types of clinical trials for ADHD
Clinical trials for ADHD include various types of studies aimed at improving treatment and understanding the disorder. These trials often include randomized controlled trials (RCTs), observational studies, and behavioral intervention trials.
Observational studies
Observational studies are designed to watch and learn from those living with ADHD to better understand how symptoms manifest themselves, identify patterns, and gather insights. This could include monitoring a group of participants or studying previously collected data to establish more outcomes.
Researchers may observe people with ADHD in a medical setting, although real-world environments typically offer better outcomes, particularly for children with ADHD. If designed and carried out properly, researchers can gather valuable data that can be used to inform treatment options or preventative measures.
Treatment trials
Treatment trials are used to test new treatments for ADHD. There are several types of treatment trials available to researchers, depending on the objective or desired outcome. One common type is randomized controlled trials (RCTs), where participants are assigned to either a treatment group or a placebo group to test the effectiveness and safety of medications, such as stimulants or non-stimulants.
Researchers may also use behavioral therapy trials to test new therapies, device trials to test new gadgets and tools for ADHD, or combination treatment trials which test medications and therapies or devices together.
Quality of life trials
In quality of life trials, researchers aim to discover ways to improve the lives of those living with ADHD. They are typically designed as a combination trial, observing participants before testing treatments to see which treatments make their life better. Researchers will seek to help participants manage symptoms and enhance their daily function.
Do ADHD trial participants get paid?
Some studies offer compensation for time and travel, and study related care is typically provided at no cost to participants. Compensation varies by trial and is always described during the informed consent process before you agree to anything.
Curious whether clinical trials pay participants? Here's how compensation actually works.
Who can participate in ADHD clinical trials?
Every study sets its own rules. ADHD has no stages, so trials recruit by age and by situation instead. Some take children and adolescents, including the new solriamfetol studies on this page. For a child, a parent or guardian gives permission, and the child agrees too when old enough. Other studies take adults, a group research overlooked for years. And some look for specific situations: pregnant women managing ADHD, adults who have ADHD together with autism, or children with ADHD plus anxiety. Studies usually ask which ADHD presentation you have, and many have rules about the medication you take now. Eligibility always varies by study.
Considering volunteering in a clinical trial? Explore our comprehensive guide to learn more about why people choose to volunteer and the impact you can make in advancing medical research. Discover the process of volunteering, what to consider before applying and the potential benefits and risks involved.
How to enroll in an ADHD clinical trial
Enrolling in a clinical trial studying ADHD through our platform is a straightforward and user-friendly process. Here's how to get started:
- Identify Your Trial: Use our intuitive search bar or filter options to locate clinical trials specific to requirements. This first step simplifies the process of finding relevant research studies tailored to your needs.
- Select Your Preferred Location: To find trials conveniently located near you, simply input your preferred location into the dedicated filter bar on the left-hand side of the page.
- Explore Study Details: For in-depth information about each study, simply click the “Learn More” button. This will provide you with comprehensive details about the trial, including objectives, procedures, and eligibility criteria.
- Complete the Health Profile: After clicking on the “Get started” button you will be taken to our efficient 5-step application process to provide important health information. This helps us match you with the clinical trial that best fits your needs.
- Submit the Application: After completing the application, send it in. A clinical trial coordinator will review it and contact you regarding the possibility of participation.