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Double Blind Trial of Duloxetine in Chronic Fatigue Syndrome (CFS)

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ClinicalTrials.gov Identifier: NCT00375973
Recruitment Status : Completed
First Posted : September 13, 2006
Results First Posted : July 27, 2015
Last Update Posted : August 21, 2015
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Lesley M. Arnold, M.D., University of Cincinnati

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Fatigue Syndrome, Chronic
Interventions Drug: Duloxetine
Drug: Placebo
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description

Duloxetine po 60-120 mg/day for 12 weeks

Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks

Placebo comparator to Duloxetine

Placebo: Sugar pill dose comparable to duloxetine

Period Title: Overall Study
Started 30 30
Completed 20 28
Not Completed 10 2
Arm/Group Title Duloxetine Placebo Total
Hide Arm/Group Description

Duloxetine po 60-120 mg/day for 12 weeks

Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks

Placebo comparator to Duloxetine

Placebo: Sugar pill dose comparable to duloxetine

Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
 100.0%
30
 100.0%
60
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
43.0  (11.8) 44.3  (11.0) 43.6  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
26
  86.7%
26
  86.7%
52
  86.7%
Male
4
  13.3%
4
  13.3%
8
  13.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 30 participants 60 participants
30 30 60
1.Primary Outcome
Title Change From Baseline in Multidimensional Fatigue Inventory (MFI)--General Fatigue Subscale Score
Hide Description

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.

Time Frame Baseline to endpoint at 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For the efficacy analysis, in the duloxetine group, 3 patients were not included in analysis for the following reasons: one patient's treatment group assignment was unblinded owing to a serious adverse event of suicidal ideation; 2 other patients did not have compliant postbaseline visits.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:

Duloxetine po 60-120 mg/day for 12 weeks

Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks

Placebo comparator to Duloxetine

Placebo: Sugar pill dose comparable to duloxetine

Overall Number of Participants Analyzed 27 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.3  (4.2) -1.8  (2.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Brief Pain Inventory (BPI) --Average Pain Severity Score
Hide Description 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).
Time Frame Baseline to endpoint at 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For the efficacy analysis, in the duloxetine group, 3 patients were not included in analysis for the following reasons: one patient's treatment group assignment was unblinded owing to a serious adverse event of suicidal ideation; 2 other patients did not have compliant postbaseline visits.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:

Duloxetine po 60-120 mg/day for 12 weeks

Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks

Placebo comparator to Duloxetine

Placebo: Sugar pill dose comparable to duloxetine

Overall Number of Participants Analyzed 27 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.6  (1.5) -0.8  (2.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) --Depression Subscale
Hide Description 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.
Time Frame baseline to endpoint at 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For the efficacy analysis, in the duloxetine group, 3 patients were not included in analysis for the following reasons: one patient's treatment group assignment was unblinded owing to a serious adverse event of suicidal ideation; 2 other patients did not have compliant postbaseline visits.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:

Duloxetine po 60-120 mg/day for 12 weeks

Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks

Placebo comparator to Duloxetine

Placebo: Sugar pill dose comparable to duloxetine

Overall Number of Participants Analyzed 27 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.6  (2.9) -1.9  (3.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in the Clinical Global Impression of Severity (CGI-S)
Hide Description Clinician rated assessment of severity on a 1 (normal)-7 (extremely ill) scale. A decrease in the score indicates improvement.
Time Frame baseline to endpoint at 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
For the efficacy analysis, in the duloxetine group, 3 patients were not included in analysis for the following reasons: one patient's treatment group assignment was unblinded owing to a serious adverse event of suicidal ideation; 2 other patients did not have compliant postbaseline visits.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:

Duloxetine po 60-120 mg/day for 12 weeks

Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks

Placebo comparator to Duloxetine

Placebo: Sugar pill dose comparable to duloxetine

Overall Number of Participants Analyzed 27 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.1  (1.2) -0.4  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
5.Secondary Outcome
Title Patient Global Impression of Improvement (PGI-I)
Hide Description Patient rated assessment of change on a 1 (very much better) to 7 (very much worse) scale.
Time Frame baseline to endpoint at 12 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
For the efficacy analysis, in the duloxetine group, 3 patients were not included in analysis for the following reasons: one patient's treatment group assignment was unblinded owing to a serious adverse event of suicidal ideation; 2 other patients did not have compliant postbaseline visits.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:

Duloxetine po 60-120 mg/day for 12 weeks

Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks

Placebo comparator to Duloxetine

Placebo: Sugar pill dose comparable to duloxetine

Overall Number of Participants Analyzed 27 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.2  (1.2) 3.3  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
6.Secondary Outcome
Title Number of Participants Who Discontinued the Study for Any Reason
Hide Description 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.
Time Frame Any time after randomization up to 12 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:

Duloxetine po 60-120 mg/day for 12 weeks

Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks

Placebo comparator to Duloxetine

Placebo: Sugar pill dose comparable to duloxetine

Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: participants
10 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants Who Discontinued Use of Treatment Due to Adverse Events
Hide Description Paticipants who dropped out of the study because of intolerable adverse events.
Time Frame Any time after randomization up to 12 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
One patient in the duloxetine group did not have post-baseline data.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:

Duloxetine po 60-120 mg/day for 12 weeks

Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks

Placebo comparator to Duloxetine

Placebo: Sugar pill dose comparable to duloxetine

Overall Number of Participants Analyzed 29 30
Measure Type: Number
Unit of Measure: participants
3 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description

Duloxetine po 60-120 mg/day for 12 weeks

Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks

Placebo comparator to Duloxetine

Placebo: Sugar pill dose comparable to duloxetine

All-Cause Mortality
Duloxetine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Duloxetine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/29 (3.45%)      0/30 (0.00%)    
Psychiatric disorders     
Suicidal ideation *  1/29 (3.45%)  1 0/30 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Duloxetine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/29 (100.00%)      30/30 (100.00%)    
Gastrointestinal disorders     
Nausea *  19/29 (65.52%)  6/30 (20.00%) 
dry mouth *  6/29 (20.69%)  1/30 (3.33%) 
Constipation *  8/29 (27.59%)  5/30 (16.67%) 
Decreased appetite *  5/29 (17.24%)  1/30 (3.33%) 
Diarrhea *  5/29 (17.24%)  3/30 (10.00%) 
Increased appetite *  2/29 (6.90%)  2/30 (6.67%) 
Abdominal pain *  2/29 (6.90%)  0/30 (0.00%) 
Infections and infestations     
Cold virus *  5/29 (17.24%)  7/30 (23.33%) 
Fever *  2/29 (6.90%)  0/30 (0.00%) 
Sinus infection *  2/29 (6.90%)  2/30 (6.67%) 
Vaginal infection *  2/29 (6.90%)  1/30 (3.33%) 
Metabolism and nutrition disorders     
Weight gain *  2/29 (6.90%)  0/30 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscle fasciculation *  2/29 (6.90%)  0/30 (0.00%) 
Nervous system disorders     
Somnolence *  12/29 (41.38%)  3/30 (10.00%) 
dizziness *  9/29 (31.03%)  2/30 (6.67%) 
headache *  3/29 (10.34%)  12/30 (40.00%) 
Lightheadedness *  5/29 (17.24%)  3/30 (10.00%) 
Increased yawning *  3/29 (10.34%)  1/30 (3.33%) 
Jittery *  3/29 (10.34%)  0/30 (0.00%) 
Psychiatric disorders     
Insomnia *  10/29 (34.48%)  4/30 (13.33%) 
Anxiety *  4/29 (13.79%)  1/30 (3.33%) 
Vivid dreams *  4/29 (13.79%)  1/30 (3.33%) 
Depression *  2/29 (6.90%)  1/30 (3.33%) 
Irritabililty *  2/29 (6.90%)  4/30 (13.33%) 
Renal and urinary disorders     
Increased urination *  3/29 (10.34%)  0/30 (0.00%) 
Skin and subcutaneous tissue disorders     
Increased sweating *  3/29 (10.34%)  0/30 (0.00%) 
Chills *  2/29 (6.90%)  0/30 (0.00%) 
Pruritus *  2/29 (6.90%)  2/30 (6.67%) 
Vascular disorders     
Hot flush *  2/29 (6.90%)  0/30 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lesley M. Arnold, M.D.
Organization: University of Cincinnati College of Medicine
Phone: 513-558-7700
EMail: lesley.arnold@uc.edu
Layout table for additonal information
Responsible Party: Lesley M. Arnold, M.D., University of Cincinnati
ClinicalTrials.gov Identifier: NCT00375973     History of Changes
Other Study ID Numbers: 06-05-01-02
First Submitted: September 12, 2006
First Posted: September 13, 2006
Results First Submitted: March 18, 2015
Results First Posted: July 27, 2015
Last Update Posted: August 21, 2015