To discover and test new, safe methods of treatment and therapies for illnesses and disorders, the National Institutes of Health (NIH) sponsors clinical trials. These closely monitored trials are conducted under the auspices and supervision of experienced and skilled healthcare professionals and clinicians in healthcare facilities or in environments such as hospitals and research labs.

Equally important to a clinical trial and its subsequent findings is the participant. Whether or not participants in clinical trials have the very illness or are taking medication for which the trial is being conducted, their inclusion and efforts in the trial is critical to ensure accurate and beneficial outcomes.

Clinical trials cover a wide range of disorders, therapies, and medication—including those related to attention deficit hyperactivity disorder (ADHD). As a health care professional, you may be approached by a patient with ADHD, or by a parent of a child with ADHD who expresses interest in participating in clinical trials for him- or herself or his or her child. Or you may determine that a patient of yours may benefit from or contribute to such a trial.

This section is designed to help you communicate to your patient/parent information about ADHD-related clinical trials. It also outlines the basics of clinical trials, and offers information on how those interested may participate. In addition, information is presented about current, ongoing trials.

Communicating to Your Patient: What Is a Clinical Trial?¹
Source: NIH

A clinical trial is a research study designed to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also referred to as medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work.

Ideas for clinical trials usually come from researchers and other health professionals. When new therapies or procedures have been tested in the laboratory and produce promising results, clinical trials are the next step. New treatments and therapies are first tested in the laboratory and in animal studies before being tested on humans and only when desired and successful results have been produced. Communicate to your patient that because they involve much preliminary testing and well-documented research, clinical trials are proven to be safe for the participant.

Participating in a Clinical Trial²
Although anyone can participate in a clinical trial, one must be aware that all trials have guidelines about who can get into the program. Several factors may play a role in the process: age, type of disease, medical history, and current medical condition. Before he or she joins a clinical trial, your patient must first qualify for the study. The factors vary from one trial to the next, so patients should be aware that exclusion from one trial may mean inclusion in another. The patient should be made aware that such criteria do not discriminate applicants on a personal basis, and he or she should not be discouraged from such protocol. Make sure that the patient knows as much as possible about the research study in which he or she is interested. The following is a list of questions that he or she may want to consider (a more comprehensive list is available at www.ClinicalTrials.gov)³:

• Why is this research being done?
• What is the purpose of the study?
• Who is sponsoring the study?
• Who has reviewed and approved this study?
• Where is the study site and how long will it last?
• What kinds of therapies, procedures, and/or tests will I have during the trial?
• How often will I have to go to the study site?
• Who will provide my medical care after the study ends?
• What medications, procedures, or treatments must I avoid while in the study?
• Will I be able to find out the results of the trial?

As a participant, your patient will be evaluated and closely monitored by the administrators of the clinical trial to ensure his or her safety throughout and after the trial.

Current NIH Trials for ADHD

The NIH is currently sponsoring several ADHD-related clinical trials. Several are listed below. These are available at the NIH's clinical trials Web site at: http://www.nimh.nih.gov/studies/1add.cfm. Please refer often to these trials to ensure their timeliness and applicability to your patient⁴:

• Behavioral and MRI Studies of Motor Control in Children with ADHD and in Healthy Volunteers: Examines how the brain controls whether a person performs a motor act, such as pushing a button.
• Treatment of ADHD in Preschool and School-Age Children (PATS): Focuses on the treatment of ADHD in very young children.
• Study of ADHD Using Transcranial Magnetic Stimulation (TMS): Studies normal children and those diagnosed with ADHD using TMS, a non-invasive technique that gives information about brain function.

For more information about clinical trials, please visit the NIH-sponsored trials at www.ClinicalTrials.gov. For information about ADHD-related trials, please visit the National Institute of Mental Health at http://www.nimh.nih.gov.

References
Clinical Trials of ADHD

1. National Institutes of Health. "What Is a Clinical Trial?" Available at: http://www.clinicaltrials.gov/ct/gui/c/w1r/info/whatis?JServSessionIdzone_ct=u2q3t0gz32#TRIAL
   Accessed 29 March 2002.

2. National Institutes of Health. "Who Can Participate in a Clinical Trial?" Available at: http://www.clinicaltrials.gov/ct/gui/c/w1r/info/whatis?JServSessionIdzone_ct=u2q3t0gz32#TRIAL

3. National Institutes of Health. "What Questions Should I Ask?" Available at: http://www.clinicaltrials.gov/ct/gui/c/w1r/info/whatis?iJServSessionIdzone_ct=u2q3t0gz32#TRIAL

4. National Institutes of Health. Clinical Trials.gov. Available at: http://www.clinicaltrials.gov/ct/gui/c/w1r/action/SearchAction?JServSessionIdzone_ct=u2q3t0gz32&Term=adhd Accessed 29 March 2002.