Fatigue Syndrome, ChronicPhase 2/3CFSNCT00375973
Double Blind Trial of Duloxetine in Chronic Fatigue Syndrome
A Phase 2/3 study testing Duloxetine in people with Fatigue Syndrome, Chronic, run by University of Cincinnati at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fatigue Syndrome, Chronic
- What is being tested?
- Duloxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Mar 2014
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Women's Health Research Program
Cincinnati, Ohio, 45219
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind Trial of Duloxetine in the Treatment of Patients With Chronic Fatigue Syndrome
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).
Read the 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.
- Conditions
- Fatigue Syndrome, Chronic
- Being tested
- Duloxetine, Placebo
- Keywords
- Fatigue, Fatigue syndrome, chronic, Chronic fatigue syndrome, CFS, Fibromyalgia
- Medical subject headings
- Fatigue Syndrome, Chronic, Fatigue, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called Cymbalta
Duloxetine po 60-120 mg/day for 12 weeks
PlaceboDrug
Also called Sugar Pill
Sugar pill dose comparable to duloxetine
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine | Experimental | Duloxetine po 60-120 mg/day for 12 weeks Receives: Drug: Duloxetine |
| Placebo | Placebo comparator | Placebo comparator to Duloxetine Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to endpoint at 12 weeks
Secondary outcomes (6)
Change From Baseline in Brief Pain Inventory (BPI) --Average Pain Severity Score
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).
Measured: Baseline to endpoint at 12 weeks
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) --Depression Subscale
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.
Measured: baseline to endpoint at 12 weeks
Change From Baseline in the Clinical Global Impression of Severity (CGI-S)
Clinician rated assessment of severity on a 1 (normal)-7 (extremely ill) scale. A decrease in the score indicates improvement.
Measured: baseline to endpoint at 12 weeks
Patient Global Impression of Improvement (PGI-I)
Patient rated assessment of change on a 1 (very much better) to 7 (very much worse) scale.
Measured: baseline to endpoint at 12 weeks.
Number of Participants Who Discontinued the Study for Any Reason
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.
Measured: Any time after randomization up to 12 weeks.
Number of Participants Who Discontinued Use of Treatment Due to Adverse Events
Paticipants who dropped out of the study because of intolerable adverse events.
Measured: Any time after randomization up to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionJun 2012
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fatigue Syndrome, ChronicStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Lesley M. Arnold, M.D., University of Cincinnati
- Investigators
- Lesley M Arnold, MD, Principal investigator, University of Cincinnati Women's Health Research Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375973
- Sponsor's protocol ID
- 06-05-01-02
- Acronym
- CFS
- Status last verified
- Jul 2015
- First submitted
- 12 Sep 2006
- Last updated
- 21 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 25660434
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind Trial of Duloxetine in the Treatment of Patients With Chronic Fatigue Syndrome
- ClinicalTrials.gov ID
- NCT00375973
- Acronym / sponsor ID
- CFS / 06-05-01-02
- Conditions
- Fatigue Syndrome, Chronic
- Keywords
- Fatigue, Fatigue syndrome, chronic, Chronic fatigue syndrome, CFS, Fibromyalgia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Sep 2006
- Primary completion
- Jun 2012 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 13 Sep 2006 (estimated)
- Results
- Posted 27 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duloxetine | Experimental | Drug: DuloxetineDuloxetine po 60-120 mg/day for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo comparator to Duloxetine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuloxetineAlso: CymbaltaDuloxetine po 60-120 mg/day for 12 weeks | Drug | Duloxetine |
| PlaceboAlso: Sugar PillSugar pill dose comparable to duloxetine | Drug | Placebo |
Primary outcome
Change From Baseline in Multidimensional Fatigue Inventory (MFI)--General Fatigue Subscale Score
Time frame: Baseline to endpoint at 12 weeks
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.
6 secondary outcomes
Change From Baseline in Brief Pain Inventory (BPI) --Average Pain Severity Score
Time frame: Baseline to endpoint at 12 weeks
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) --Depression Subscale
Time frame: baseline to endpoint at 12 weeks
Change From Baseline in the Clinical Global Impression of Severity (CGI-S)
Time frame: baseline to endpoint at 12 weeks
Patient Global Impression of Improvement (PGI-I)
Time frame: baseline to endpoint at 12 weeks.
Number of Participants Who Discontinued the Study for Any Reason
Time frame: Any time after randomization up to 12 weeks.
Number of Participants Who Discontinued Use of Treatment Due to Adverse Events
Time frame: Any time after randomization up to 12 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25660434Arnold 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lesley M Arnold, MD principal investigator
University of Cincinnati Women's Health Research Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Duloxetine in people with Fatigue Syndrome, Chronic, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Multidimensional Fatigue Inventory (MFI)--General Fatigue Subscale Score (time frame: Baseline to endpoint at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00375973, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2015.