| City: |
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Cincinnati |
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State:
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OH |
| Zip Code: |
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45219 |
| Conditions: |
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Fatigue Syndrome, Chronic |
| Purpose: |
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The purpose of this study is to determine the safety and efficacy of duloxetine compared
with placebo for reducing fatigue in patients diagnosed with Chronic Fatigue Syndrome (CFS).
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| Study summary: |
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Chronic fatigue syndrome (CFS) is characterized by severe disabling fatigue of at least six
months duration that cannot be fully explained by an identifiable medical condition . Pain
symptoms are also a part of the diagnostic criteria for CFS, and include muscle pain,
multi-joint pain, and headaches. The prevalence of CFS ranges from 0.007 to 2.8 % in the
general adult population and 0.006 to 3.0% in primary care practice (2). Although most who
receive a CFS diagnosis are 30-40 years of age, Caucasian, and female, CFS affects both
women and men, adults and children, and all racial and socioeconomic classes.
Patients with CFS have 2-4 times the rate of depression and anxiety compared with the
general population. CFS is also commonly comorbid with fibromyalgia, a disorder
characterized by chronic widespread pain, tenderness, fatigue, sleep and mood disturbances.
In some samples, 70% of patients with fibromyalgia also meet criteria for CFS. CFS and
fibromyalgia are characterized by greater similarities than differences and may share
pathophysiologic features. Like fibromyalgia, CFS is associated with chronic pain, sleep and
mood disturbances. Because fibromyalgia responds to treatment with antidepressants,
particularly the dual serotonin and norepinephrine reuptake inhibitors, including
duloxetine, antidepressant trials in CFS are clearly needed. |
| Criteria: |
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Inclusion Criteria:
1. Female and male outpatients between 18-65 years of age.
2. Meet criteria for revised CDC definition of Chronic Fatigue Syndrome (CFS) (at least
6 months of persistent fatigue that substantially reduces the person's level of
activity; 4 or more of the following symptoms that must occur with fatigue in a
6-month period: impaired memory or concentration, sore throat, tender glands, aching
or stiff muscles, multijoint pain, new headaches, unrefreshing sleep, and
post-exertional fatigue. Medical conditions that may explain the fatigue and
psychiatric disorders, including eating disorders, psychotic disorders, bipolar
disorder, melancholic depression, and substance abuse within 2 years of the onset of
fatigue, are excluded).
3. Provision of written informed consent for participation in the trial.
4. Educational level and degree of understanding such that the patient can communicate
intelligibly with the investigator and study staff.
5. Judged to be reliable and agree to keep all appointments for clinic visits, tests,
and procedures required by the protocol.
Exclusion Criteria:
1. Current melancholic major depressive disorder, or a previous diagnosis of psychosis,
eating disorder, or bipolar disorder.
2. History of substance abuse or dependence within the past year, excluding nicotine and
caffeine.
3. A positive urine drug screen for any substance of abuse (may be retested if positive
test was for a prescribed medication that was not washed out).
4. Women who are pregnant or breast feeding; women must test negative for pregnancy at
Visit 1.
5. Women of childbearing potential who are not using a medically accepted means of
contraceptive when engaging in sexual intercourse.
6. Patients who, in the opinion of the investigator, are treatment-refractory or whose
response is likely to be compromised by existing or future disability compensation
issues.
7. Serious unstable medical illness, including cardiovascular, hepatic, renal,
respiratory, or hematologic illness, 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. Abnormal TSH
concentrations (unless treatment for hypothyroidism has been stable for at least the
past 3 months and the patient is clinically euthyroid).
8. Patients who have uncontrolled narrow-angle glaucoma.
9. Patients who have acute liver injury (such as hepatitis) or severe cirrhosis
(Child-Pugh Class C).
10. Patients who are judged prior to randomization to be at suicidal risk by the clinical
investigator.
11. Treatment with antidepressant medication within 14 days prior to randomization with
the exception of fluoxetine, which cannot be used within 30 days prior to
randomization. Potential need to use a MAOI during the study or within 2 weeks of
discontinuation of study treatment.
12. Patients who have previously taken duloxetine
13. Patients who are taking any excluded medications that cannot be discontinued at Visit
1.
14. Treatment within the last 30 days with a drug that has not received regulatory
approval at the time of study entry.
15. Known hypersensitivity to duloxetine or any of the inactive ingredients. |
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| Study is available at: |
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Women's Health Research Program
Cincinnati, OH 45219
United States
Primary Contact:
Elizabeth Mariutto
Email: elizabeth.mariutto@uc.edu
Phone: 513-475-8119
Secondary Contact:
Elizabeth Mariutto
Email: elizabeth.mariutto@uc.edu
Phone: 513-475-8119 |
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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 21, 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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