Clinical Trial: Double Blind Trial of Duloxetine in Chronic Fatigue Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Placebo-Controlled, Double-Blind Trial of Duloxetine in the Treatment of Patients With Chronic Fatigue Syndrome

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).

Detailed Summary:

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.

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

Original Primary Outcome: Multidimensional Fatigue Inventory (MFI)

Current Secondary Outcome:

• 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).
• 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.
• 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.
• 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.
• 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.
• 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.

Original Secondary Outcome:

• 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

Dates:
Date Received: September 12, 2006
Date Started: September 2006
Date Completion:
Last Updated: July 31, 2015
Last Verified: July 2015