Chronic Fatigue Syndrome

Over the past decade, the Rochester Center for Behavioral Medicine (RCBM) has evaluated many
patients with attention deficit hyperactivity disorder (ADHD). A recurrent finding in these
patients is a history of unexplained fatigue and musculoskeletal pain. Some of these
patients have previously been identified by other treatment providers as having fibromyalgia
syndrome (FMS) or chronic fatigue syndrome (CFS). Many of these patients have been
evaluated within the traditional medical system, often by rheumatologists and neurologists.
Others have been evaluated in non-traditional settings by chiropractors and nutritionists.
Physicians shun these patients as their complaints are persistent. They are perceived to be
malingering or opiate seeking. Many physicians will remark that they do not believe in these
conditions. Rather uniformly, patients and their doctors are unhappy with the results of
treatment. This dynamic is consistent with the experience of adult ADHD patients prior to
the acceptance of this condition.

Treatment of these patients in our clinic has revealed that when their underlying ADHD is
treated with psychostimulant medication, many patients report significant improvements with
regard to their fatigue and musculoskeletal pain. Patients report less subjective fatigue
and pain and note overall functional improvement, although the initial and primary objective
was the treatment of their attention or hyperactivity problems. We speculate that stimulants
are efficacious by offering two distinct clinical properties. 1) anti-fatigue properties
and 2) properties that allow patients to filter out extraneous stimuli (i.e. chronic muscle
pain).

As a result of these findings RCBM developed a chronic fatigue/fibromyalgia clinic in the
early 2000's. This clinic was staffed by a board-certified rheumatologist and the
psychiatric staff at RCBM. Through the major referral hospital in the area, patients with
self-identified fibromyalgia and chronic fatigue were referred to our clinic. Over eighteen
months, we evaluated 75 patients, and found that in patients who had comprehensive
evaluations, nearly 70 percent also had a history of ADHD, inattentive or combined types.
Diagnosis was made using clinical history and standardized symptom checklists. Oftentimes,
the ADHD had been previously undiagnosed. This finding supports the link between ADHD and
FMS/CFS.

Results from these evaluations reinforced our initial findings: patients who are treated for
their ADHD symptoms also show a reduction in their chronic pain and fatigue symptoms. This
is true regardless of previous (unsuccessful) therapies to treat their fibromyalgia.

As a result of these findings, we are conducting a controlled study to further demonstrate
the efficacy of lisdexamfetamine dimesylate (LDX) in controlling fatigue symptoms in
patients presenting with chronic fatigue syndrome. This is a double-blind,
placebo-controlled study over a period of 8 weeks, where subjects are randomized to either
LDX or placebo. We will evaluate subjects through standardized pain, fatigue and ADHD
assessment scales.