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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Lesley M. Arnold, M.D., University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00375973
First received: September 12, 2006
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Fatigue Syndrome, Chronic
Drug: Duloxetine
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Multidimensional Fatigue Inventory (MFI) [ Time Frame: at the time of the assessment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Brief Pain Inventory (BPI) [ Time Frame: at the time of the assessment ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: at the time of the assessment ] [ Designated as safety issue: No ]
  • Clinical Global Impression of Severity (CGI-S) [ Time Frame: at the time of the assessment ] [ Designated as safety issue: No ]
  • Patient Global Impression of Improvement (PGI-I) [ Time Frame: compared to baseline, at the time of the assessment ] [ Designated as safety issue: No ]
  • Discontinuation rates [ Time Frame: at the time of the assessment ] [ Designated as safety issue: Yes ]
  • treatment-emergent adverse events [ Time Frame: at the time of the assessment ] [ Designated as safety issue: Yes ]
  • vital signs [ Time Frame: at the time of the assessment ] [ Designated as safety issue: Yes ]
  • laboratory analyses [ Time Frame: at the time of the assessment ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: September 2006
Estimated Study Completion Date: December 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375973

Locations
United States, Ohio
Women's Health Research Program
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
University of Cincinnati
Eli Lilly and Company
Investigators
Principal Investigator: Lesley M Arnold, MD University of Cincinnati Women's Health Research Program
  More Information

Additional Information:
No publications provided

Responsible Party: Lesley M. Arnold, M.D., Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00375973     History of Changes
Other Study ID Numbers: 06-05-01-02
Study First Received: September 12, 2006
Last Updated: September 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Fatigue
Fatigue syndrome, chronic
Chronic fatigue syndrome
CFS
Fibromyalgia

Additional relevant MeSH terms:
Fatigue
Fatigue Syndrome, Chronic
Syndrome
Central Nervous System Diseases
Disease
Encephalomyelitis
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Pathologic Processes
Signs and Symptoms
Virus Diseases
Duloxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Antidepressive Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin Agents

ClinicalTrials.gov processed this record on November 27, 2014