Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Lesley M. Arnold, M.D., University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00375973
First received: September 12, 2006
Last updated: July 31, 2015
Last verified: July 2015
Results First Received: March 18, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Fatigue Syndrome, Chronic
Interventions: Drug: Duloxetine
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Duloxetine

Duloxetine po 60-120 mg/day for 12 weeks

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

Placebo

Placebo comparator to Duloxetine

Placebo: Sugar pill dose comparable to duloxetine


Participant Flow:   Overall Study
    Duloxetine   Placebo
STARTED   30   30 
COMPLETED   20   28 
NOT COMPLETED   10   2 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Duloxetine

Duloxetine po 60-120 mg/day for 12 weeks

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

Placebo

Placebo comparator to Duloxetine

Placebo: Sugar pill dose comparable to duloxetine

Total Total of all reporting groups

Baseline Measures
   Duloxetine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   60 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   30   30   60 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.0  (11.8)   44.3  (11.0)   43.6  (11.4) 
Gender 
[Units: Participants]
     
Female   26   26   52 
Male   4   4   8 
Region of Enrollment 
[Units: Participants]
     
United States   30   30   60 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Multidimensional Fatigue Inventory (MFI)--General Fatigue Subscale Score   [ Time Frame: Baseline to endpoint at 12 weeks ]

2.  Secondary:   Change From Baseline in Brief Pain Inventory (BPI) --Average Pain Severity Score   [ Time Frame: Baseline to endpoint at 12 weeks ]

3.  Secondary:   Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) --Depression Subscale   [ Time Frame: baseline to endpoint at 12 weeks ]

4.  Secondary:   Change From Baseline in the Clinical Global Impression of Severity (CGI-S)   [ Time Frame: baseline to endpoint at 12 weeks ]

5.  Secondary:   Patient Global Impression of Improvement (PGI-I)   [ Time Frame: baseline to endpoint at 12 weeks. ]

6.  Secondary:   Number of Participants Who Discontinued the Study for Any Reason   [ Time Frame: Any time after randomization up to 12 weeks. ]

7.  Secondary:   Number of Participants Who Discontinued Use of Treatment Due to Adverse Events   [ Time Frame: Any time after randomization up to 12 weeks. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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:  
Name/Title: Lesley M. Arnold, M.D.
Organization: University of Cincinnati College of Medicine
phone: 513-558-7700
e-mail: lesley.arnold@uc.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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
Study First Received: September 12, 2006
Results First Received: March 18, 2015
Last Updated: July 31, 2015
Health Authority: United States: Institutional Review Board