U. of Cincinnati Recruiting CFS Patients in Study of Duloxetine for Fatigue

Previous trials in Canada, Indiana, and elsewhere have studied the pharmaceutical drug duloxetine for treatment of pain and mood in Fibromyalgia patients. Now researchers at the University of Cincinnati Women’s Health Research Program are recruiting both male and female Chronic Fatigue Syndrome patients, ages 18 to 65, to test the drug’s efficacy for reducing fatigue in CFS – with a secondary focus on pain and depression.

They point out that as many as 70 percent of FM patients also meet criteria for CFS, and because FM responds to antidepressants such as duloxetine – dual serotonin and norepinephrine reuptake inhibitors – trials of such drugs in CFS “are clearly needed.”

Study Title & Type
A Randomized, Placebo-Controlled, Double-Blind Trial of Duloxetine in the Treatment of Patients With Chronic Fatigue Syndrome. ClinicalTrials.gov Identifier: NCT00375973

Phase II, Phase III; Interventional; Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Expected Total Enrollment: 60. Expected Last Followup: December 2009

University of Cincinnati and Eli Lilly and Company.

Determine the safety and efficacy of duloxetine compared with placebo for reducing fatigue in patients diagnosed with Chronic Fatigue Syndrome (CFS).

Primary Outcomes: Multidimensional Fatigue Inventory (MFI)
Secondary Outcomes: Efficacy:; Brief Pain Inventory (BPI); Hospital Anxiety and Depression Scale (HADS); Clinical Global Impression of Severity (CGI-S); Patient Global Impression of Improvement (PGI-I); Safety: Discontinuation rates; treatment-emergent adverse events; vital signs; laboratory analyses

Patients with CFS have 2 to 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 percent 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 for Inclusion
1. Female and male outpatients between 18-65 years of age.
2. Meet criteria for revised CDC definition of CFS (at least 6 months of persistent fatigue that substantially reduces the person’s level of activity). Four or more of the following symptoms 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. (Patients with 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 [resistant/difficult] 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 [thyroid-stimulating hormone] concentrations (unless treatment for hypothyroidism has been stable for at least the past 3 months and the patient is clinically euthyroid [normal thyroid function]).
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 [monoamine oxidase inhibitor] 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.

Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00375973
Jennifer M Hoff, MSW, LSW. Phone: 513-475-8114
E-mail: jennifer.hoff@uc.edu
Susie G Sheridan, BS. Phone: 513-475-8115 E-mail: dana.sheridan@uc.edu

Ohio Psychiatric Professional Services Inc.,
Women's Health Research Program,
Cincinnati, Ohio, 45219, United States;
Recruiting Lesley M. Arnold, MD, Principal Investigator

Principal investigator
Lesley M Arnold, MD, University of Cincinnati Women's Health Research Program

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