Double Blind Trial of Duloxetine in Chronic Fatigue Syndrome

NCT00375973 | Completed Phase 2 Results

• 1 other identifier: 06-05-01-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Fatigue Syndrome, Chronic

Keywords

Fatigue; Fatigue syndrome, chronic; Chronic fatigue syndrome; CFS; Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Multidimensional Fatigue Inventory (MFI)--General Fatigue Subscale Score

  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.

  Baseline to endpoint at 12 weeks

Secondary Outcomes (6)

• Change From Baseline in Brief Pain Inventory (BPI) --Average Pain Severity Score

  Baseline to endpoint at 12 weeks

• Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) --Depression Subscale

  baseline to endpoint at 12 weeks

• Change From Baseline in the Clinical Global Impression of Severity (CGI-S)

  baseline to endpoint at 12 weeks

• Patient Global Impression of Improvement (PGI-I)

  baseline to endpoint at 12 weeks.

• Number of Participants Who Discontinued the Study for Any Reason

  Any time after randomization up to 12 weeks.

Study Arms (2)

Duloxetine

EXPERIMENTAL

Duloxetine po 60-120 mg/day for 12 weeks

Drug: Duloxetine

Placebo

PLACEBO COMPARATOR

Placebo comparator to Duloxetine

Drug: Placebo

Interventions

Duloxetine DRUG

Duloxetine po 60-120 mg/day for 12 weeks

Also known as: Cymbalta

Duloxetine

Placebo DRUG

Sugar pill dose comparable to duloxetine

Also known as: Sugar Pill

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female and male outpatients between 18-65 years of age.
• 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).
• Provision of written informed consent for participation in the trial.
• Educational level and degree of understanding such that the patient can communicate intelligibly with the investigator and study staff.
• Judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures required by the protocol.

You may not qualify if:

• Current melancholic major depressive disorder, or a previous diagnosis of psychosis, eating disorder, or bipolar disorder.
• History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
• 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).
• Women who are pregnant or breast feeding; women must test negative for pregnancy at Visit 1.
• Women of childbearing potential who are not using a medically accepted means of contraceptive when engaging in sexual intercourse.
• 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.
• 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).
• Patients who have uncontrolled narrow-angle glaucoma.
• Patients who have acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C).
• Patients who are judged prior to randomization to be at suicidal risk by the clinical investigator.
• 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.
• Patients who have previously taken duloxetine
• Patients who are taking any excluded medications that cannot be discontinued at Visit 1.
• Treatment within the last 30 days with a drug that has not received regulatory approval at the time of study entry.
• Known hypersensitivity to duloxetine or any of the inactive ingredients.

Sponsors & Collaborators

• University of Cincinnati: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Women's Health Research Program

Cincinnati, Ohio, 45219, United States

Location

Related Publications (1)

• Arnold LM, Blom TJ, Welge JA, Mariutto E, Heller A. A randomized, placebo-controlled, double-blinded trial of duloxetine in the treatment of general fatigue in patients with chronic fatigue syndrome. Psychosomatics. 2015 May-Jun;56(3):242-53. doi: 10.1016/j.psym.2014.12.003. Epub 2014 Dec 16.

  PMID: 25660434 DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Fatigue; Fibromyalgia

Interventions

Duloxetine Hydrochloride; Sugars

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Lesley M. Arnold, M.D.
• Organization: University of Cincinnati College of Medicine

lesley.arnold@uc.edu

513-558-7700

Study Officials

• Lesley M Arnold, MD

  University of Cincinnati Women's Health Research Program

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 12, 2006
• First Posted: September 13, 2006
• Study Start: September 1, 2006
• Primary Completion: June 1, 2012
• Study Completion: March 1, 2014
• Last Updated: August 21, 2015
• Results First Posted: July 27, 2015

Record last verified: 2015-07

Locations

US (1)