Double Blind Trial of Duloxetine in Chronic Fatigue Syndrome
关键词
抽象
描述
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.
日期
| 最后验证: | 06/30/2015 |
| 首次提交: | 09/11/2006 |
| 提交的预估入学人数: | 09/11/2006 |
| 首次发布: | 09/12/2006 |
| 上次提交的更新: | 07/30/2015 |
| 最近更新发布: | 08/20/2015 |
| 首次提交结果的日期: | 03/17/2015 |
| 首次提交质量检查结果的日期: | 06/28/2015 |
| 首次发布结果的日期: | 07/26/2015 |
| 实际学习开始日期: | 08/31/2006 |
| 预计主要完成日期: | 05/31/2012 |
| 预计完成日期: | 02/28/2014 |
状况或疾病
干预/治疗
Drug: Duloxetine
Drug: Placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Duloxetine Duloxetine po 60-120 mg/day for 12 weeks | Drug: Duloxetine Duloxetine po 60-120 mg/day for 12 weeks |
| Placebo Comparator: Placebo Placebo comparator to Duloxetine | Drug: Placebo Sugar pill dose comparable to duloxetine |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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. |
结果
主要结果指标
1. Change From Baseline in Multidimensional Fatigue Inventory (MFI)--General Fatigue Subscale Score [Baseline to endpoint at 12 weeks]
次要成果指标
1. Change From Baseline in Brief Pain Inventory (BPI) --Average Pain Severity Score [Baseline to endpoint at 12 weeks]
2. Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) --Depression Subscale [baseline to endpoint at 12 weeks]
3. Change From Baseline in the Clinical Global Impression of Severity (CGI-S) [baseline to endpoint at 12 weeks]
4. Patient Global Impression of Improvement (PGI-I) [baseline to endpoint at 12 weeks.]
5. Number of Participants Who Discontinued the Study for Any Reason [Any time after randomization up to 12 weeks.]
6. Number of Participants Who Discontinued Use of Treatment Due to Adverse Events [Any time after randomization up to 12 weeks.]
