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Double Blind Trial of Duloxetine in Chronic Fatigue Syndrome (CFS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00375973
Recruitment Status : Completed
First Posted : September 13, 2006
Results First Posted : July 27, 2015
Last Update Posted : August 21, 2015
Eli Lilly and Company
Information provided by (Responsible Party):
Lesley M. Arnold, M.D., University of Cincinnati

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Fatigue Syndrome, Chronic Drug: Duloxetine Drug: Placebo Phase 2 Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-Blind Trial of Duloxetine in the Treatment of Patients With Chronic Fatigue Syndrome
Study Start Date : September 2006
Actual Primary Completion Date : June 2012
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Duloxetine
Duloxetine po 60-120 mg/day for 12 weeks
Drug: Duloxetine
Duloxetine po 60-120 mg/day for 12 weeks
Other Name: Cymbalta

Placebo Comparator: Placebo
Placebo comparator to Duloxetine
Drug: Placebo
Sugar pill dose comparable to duloxetine
Other Name: Sugar Pill

Primary Outcome Measures :
  1. Change From Baseline in Multidimensional Fatigue Inventory (MFI)--General Fatigue Subscale Score [ Time Frame: Baseline to endpoint at 12 weeks ]

    The MFI is a self-reported instrument that contains 20 statements covering different aspects of fatigue. The MFI consists of 5 subscales: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced concentration. Each subscale includes 4 items with 5-point Likert scales. Scores on each subscale range from 4-20 with higher scores indicating greater fatigue. A decrease in the score indicates improvement.

    The general fatigue subscale (primary measure) includes general statements about tiredness, feeling rested, and overall feelings of being fit.

Secondary Outcome Measures :
  1. Change From Baseline in Brief Pain Inventory (BPI) --Average Pain Severity Score [ Time Frame: Baseline to endpoint at 12 weeks ]
    The BPI is a self-administered scale that measures the severity of pain. Pain severity is rated on a 0 [no pain] to 10 [pain as bad a you can imagine] scale. Average pain is rated over the previous 24 hours. Higher scores indicate greater pain severity. A decrease in the score indicates improvement (i.e. decrease in pain severity).

  2. Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) --Depression Subscale [ Time Frame: baseline to endpoint at 12 weeks ]
    The HADS is a self-reported instrument designed as a brief assessment tool of anxiety and depression in nonpsychiatric populations. It is a 14-item questionnaire that consistes of 2 subscales of 7 items designed to measure levels of both anxiety and depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores indicate greater levels of anxiety or depression. A decrease in the score indicates improvement.

  3. Change From Baseline in the Clinical Global Impression of Severity (CGI-S) [ Time Frame: baseline to endpoint at 12 weeks ]
    Clinician rated assessment of severity on a 1 (normal)-7 (extremely ill) scale. A decrease in the score indicates improvement.

  4. Patient Global Impression of Improvement (PGI-I) [ Time Frame: baseline to endpoint at 12 weeks. ]
    Patient rated assessment of change on a 1 (very much better) to 7 (very much worse) scale.

  5. Number of Participants Who Discontinued the Study for Any Reason [ Time Frame: Any time after randomization up to 12 weeks. ]
    Description of discontinuation rates of participants; all participants who dropped out of the study after randomization were included. The reasons for drop outs included lack of efficacy, adverse event, lost to follow-up, personal conflict or other patient decision, withdrawal of informed consent, and non-compliance.

  6. Number of Participants Who Discontinued Use of Treatment Due to Adverse Events [ Time Frame: Any time after randomization up to 12 weeks. ]
    Paticipants who dropped out of the study because of intolerable adverse events.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Female and male outpatients between 18-65 years of age.
  2. Meet criteria for revised Center for Disease Control (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 thyroid stimulating hormone (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 monoamine oxidase inhibitor (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00375973

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United States, Ohio
Women's Health Research Program
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
University of Cincinnati
Eli Lilly and Company
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Principal Investigator: Lesley M Arnold, MD University of Cincinnati Women's Health Research Program
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lesley M. Arnold, M.D., Professor, University of Cincinnati Identifier: NCT00375973    
Other Study ID Numbers: 06-05-01-02
First Posted: September 13, 2006    Key Record Dates
Results First Posted: July 27, 2015
Last Update Posted: August 21, 2015
Last Verified: July 2015
Keywords provided by Lesley M. Arnold, M.D., University of Cincinnati:
Fatigue syndrome, chronic
Chronic fatigue syndrome
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Pathologic Processes
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents