Double Blind Trial of Duloxetine in Chronic Fatigue Syndrome (CFS)
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).
Fatigue Syndrome, Chronic
|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|
- Change From Baseline in Multidimensional Fatigue Inventory (MFI)--General Fatigue Subscale Score [ Time Frame: Baseline to endpoint at 12 weeks ] [ Designated as safety issue: No ]
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.
- Change From Baseline in Brief Pain Inventory (BPI) --Average Pain Severity Score [ Time Frame: Baseline to endpoint at 12 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: Yes ]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. ] [ Designated as safety issue: Yes ]Paticipants who dropped out of the study because of intolerable adverse events.
|Study Start Date:||September 2006|
|Study Completion Date:||March 2014|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Duloxetine po 60-120 mg/day for 12 weeks
Duloxetine po 60-120 mg/day for 12 weeks
Other Name: Cymbalta
Placebo Comparator: Placebo
Placebo comparator to Duloxetine
Sugar pill dose comparable to duloxetine
Other Name: Sugar Pill
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00375973
|United States, Ohio|
|Women's Health Research Program|
|Cincinnati, Ohio, United States, 45219|
|Principal Investigator:||Lesley M Arnold, MD||University of Cincinnati Women's Health Research Program|