| City: |
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Rochester Hills |
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State:
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MI |
| Zip Code: |
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48307 |
| Conditions: |
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Chronic Fatigue Syndrome - Cognitive Impairments |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- BRIEF-A Global Executive Composite score (GEC) ≥ 65, or Behavioral Regulation Index
score (BRI) ≥ 65, or Metacognition Index score (MI) ≥ 65.
- Subjects must meet consensus criteria for chronic fatigue syndrome. These criteria
will be assessed by obtaining clinical histories and using appropriate symptom
checklists.
- Provide written informed consent for participation in the trial before completing any
study-related procedures.
- Are between the ages of 18 and 60, inclusive, at the time informed consent is
obtained.
- Male or non-pregnant females who are not breastfeeding. Females of reproductive
potential must agree to use a medically accepted means of contraception when engaging
in sexual intercourse at any time during the study. Females with childbearing
potential who are abstinent may enter the study if they agree that they will use
medically acceptable contraception should they should become sexually active during
the study. Women of childbearing potential must test negative for pregnancy at the
Screening Visit.
- Are able to swallow study medication.
- Have normal intelligence, are able to communicate effectively with the study team and
are likely to fully comply with study procedures and restrictions, including all
clinic visits and assessments required by the protocol.
Exclusion Criteria:
- BRIEF-A Global Executive Composite score < 65, or Behavioral Regulation Index score
(BRI) < 65, or Metacognition Index score (MI) < 65.
- Immediate family of the Investigator or others directly affiliated with the study.
- Received treatment with a drug that has not received regulatory approval or
participated in a clinical trial within 30 days prior to screening.
- Weigh less than 30 kg or greater than 120 kg at the time of informed consent, or in
the opinion of the Investigator, are significantly underweight or morbidly obese.
- Have a documented history of Bipolar I Disorder or any history of psychosis or
pervasive developmental disorder. In addition, subjects with any comorbid
psychiatric diagnosis with significant symptoms (severe Axis II disorder, or severe
Axis I disorders such as post-traumatic stress disorder, severe obsessive compulsive
disorder, severe depressive or severe anxiety disorders) will be excluded. Subjects
with mild to moderate Axis I disorders such as social phobia and dysthymia and ADHD
may be included.
- History of substance abuse or drug dependence according to DSM-IV-TRTM criteria
currently or within one year prior to study participation, excluding nicotine and
caffeine. This is determined through clinical history and symptom checklist to be
obtained at visit 1.
- Serious chronic or acute unstable medical condition or illness, including
cardiovascular, hepatic, renal, respiratory, or hematologic illness, narrow angle
glaucoma, or other unstable medical or psychiatric conditions that in the opinion of
the Investigator would compromise participation or would likely lead to
hospitalization during the duration of the study. Subjects with a history of mental
retardation or a severe learning disability are also excluded.
- History of seizure disorder (other than infantile febrile seizures), any tic
disorder, current diagnosis and/or family history of Tourette's disorder.
- Subjects with a history of organic heart disease including coronary artery disease,
past myocardial infarction, angina, arrhythmias, congestive heart failure, valvular
heart disease and congenital heart disease.
- Subject has a history of hypertension, unless controlled with a stable dose of blood
pressure medication for a period of three months or more, or has a resting sitting
systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg.
- Patients who are taking any excluded medications that cannot be discontinued prior to
beginning treatment with study medication.
- Have a known hypersensitivity, allergy intolerance or documented history of
non-responsivity to methylphenidate or amphetamine, to amphetamine-based medications,
to LDX, or to any of its ingredients.
- Subjects who, in the opinion of the Investigator, are unsuitable in any other way to
participate in the study.
- Subjects on duloxetine, bupropion or pregabalin. |
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| Study is available at: |
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Rochester Center for Behavioral Medicine
Rochester Hills, MI 48307
United States
Primary Contact:
Simon C. Levinson, M.A., tLLP
Email: slevinson@rcbm.net
Phone: 248-608-8800
Secondary Contact:
Simon C. Levinson, M.A., tLLP
Email: slevinson@rcbm.net
Phone: 248-608-8800 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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