Trial Outcomes & Findings for Double Blind Trial of Duloxetine in Chronic Fatigue Syndrome (NCT NCT00375973)
NCT ID: NCT00375973
Last Updated: 2015-08-21
Results Overview
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.
COMPLETED
PHASE2/PHASE3
60 participants
Baseline to endpoint at 12 weeks
2015-08-21
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
20
|
28
|
|
Overall Study
NOT COMPLETED
|
10
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Double Blind Trial of Duloxetine in Chronic Fatigue Syndrome
Baseline characteristics by cohort
| Measure |
Duloxetine
n=30 Participants
Duloxetine po 60-120 mg/day for 12 weeks
Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks
|
Placebo
n=30 Participants
Placebo comparator to Duloxetine
Placebo: Sugar pill dose comparable to duloxetine
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
43.0 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
44.3 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
43.6 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to endpoint at 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Duloxetine
n=27 Participants
Duloxetine po 60-120 mg/day for 12 weeks
Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks
|
Placebo
n=30 Participants
Placebo comparator to Duloxetine
Placebo: Sugar pill dose comparable to duloxetine
|
|---|---|---|
|
Change From Baseline in Multidimensional Fatigue Inventory (MFI)--General Fatigue Subscale Score
|
-3.3 units on a scale
Standard Deviation 4.2
|
-1.8 units on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Baseline to endpoint at 12 weeksPopulation: 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.
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).
Outcome measures
| Measure |
Duloxetine
n=27 Participants
Duloxetine po 60-120 mg/day for 12 weeks
Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks
|
Placebo
n=30 Participants
Placebo comparator to Duloxetine
Placebo: Sugar pill dose comparable to duloxetine
|
|---|---|---|
|
Change From Baseline in Brief Pain Inventory (BPI) --Average Pain Severity Score
|
-1.6 units on a scale
Standard Deviation 1.5
|
-0.8 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: baseline to endpoint at 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Duloxetine
n=27 Participants
Duloxetine po 60-120 mg/day for 12 weeks
Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks
|
Placebo
n=30 Participants
Placebo comparator to Duloxetine
Placebo: Sugar pill dose comparable to duloxetine
|
|---|---|---|
|
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) --Depression Subscale
|
-1.6 units on a scale
Standard Deviation 2.9
|
-1.9 units on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: baseline to endpoint at 12 weeksPopulation: 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.
Clinician rated assessment of severity on a 1 (normal)-7 (extremely ill) scale. A decrease in the score indicates improvement.
Outcome measures
| Measure |
Duloxetine
n=27 Participants
Duloxetine po 60-120 mg/day for 12 weeks
Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks
|
Placebo
n=30 Participants
Placebo comparator to Duloxetine
Placebo: Sugar pill dose comparable to duloxetine
|
|---|---|---|
|
Change From Baseline in the Clinical Global Impression of Severity (CGI-S)
|
-1.1 units on a scale
Standard Deviation 1.2
|
-0.4 units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: baseline to endpoint at 12 weeks.Population: 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.
Patient rated assessment of change on a 1 (very much better) to 7 (very much worse) scale.
Outcome measures
| Measure |
Duloxetine
n=27 Participants
Duloxetine po 60-120 mg/day for 12 weeks
Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks
|
Placebo
n=30 Participants
Placebo comparator to Duloxetine
Placebo: Sugar pill dose comparable to duloxetine
|
|---|---|---|
|
Patient Global Impression of Improvement (PGI-I)
|
3.2 units on a scale
Standard Deviation 1.2
|
3.3 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Any time after randomization up to 12 weeks.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.
Outcome measures
| Measure |
Duloxetine
n=30 Participants
Duloxetine po 60-120 mg/day for 12 weeks
Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks
|
Placebo
n=30 Participants
Placebo comparator to Duloxetine
Placebo: Sugar pill dose comparable to duloxetine
|
|---|---|---|
|
Number of Participants Who Discontinued the Study for Any Reason
|
10 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Any time after randomization up to 12 weeks.Population: One patient in the duloxetine group did not have post-baseline data.
Paticipants who dropped out of the study because of intolerable adverse events.
Outcome measures
| Measure |
Duloxetine
n=29 Participants
Duloxetine po 60-120 mg/day for 12 weeks
Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks
|
Placebo
n=30 Participants
Placebo comparator to Duloxetine
Placebo: Sugar pill dose comparable to duloxetine
|
|---|---|---|
|
Number of Participants Who Discontinued Use of Treatment Due to Adverse Events
|
3 participants
|
0 participants
|
Adverse Events
Duloxetine
Placebo
Serious adverse events
| Measure |
Duloxetine
n=29 participants at risk
Duloxetine po 60-120 mg/day for 12 weeks
Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks
|
Placebo
n=30 participants at risk
Placebo comparator to Duloxetine
Placebo: Sugar pill dose comparable to duloxetine
|
|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
3.4%
1/29 • Number of events 1
|
0.00%
0/30
|
Other adverse events
| Measure |
Duloxetine
n=29 participants at risk
Duloxetine po 60-120 mg/day for 12 weeks
Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks
|
Placebo
n=30 participants at risk
Placebo comparator to Duloxetine
Placebo: Sugar pill dose comparable to duloxetine
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
65.5%
19/29
|
20.0%
6/30
|
|
Nervous system disorders
Somnolence
|
41.4%
12/29
|
10.0%
3/30
|
|
Nervous system disorders
dizziness
|
31.0%
9/29
|
6.7%
2/30
|
|
Nervous system disorders
headache
|
10.3%
3/29
|
40.0%
12/30
|
|
Gastrointestinal disorders
dry mouth
|
20.7%
6/29
|
3.3%
1/30
|
|
Psychiatric disorders
Insomnia
|
34.5%
10/29
|
13.3%
4/30
|
|
Gastrointestinal disorders
Constipation
|
27.6%
8/29
|
16.7%
5/30
|
|
Infections and infestations
Cold virus
|
17.2%
5/29
|
23.3%
7/30
|
|
Gastrointestinal disorders
Decreased appetite
|
17.2%
5/29
|
3.3%
1/30
|
|
Gastrointestinal disorders
Diarrhea
|
17.2%
5/29
|
10.0%
3/30
|
|
Nervous system disorders
Lightheadedness
|
17.2%
5/29
|
10.0%
3/30
|
|
Psychiatric disorders
Anxiety
|
13.8%
4/29
|
3.3%
1/30
|
|
Psychiatric disorders
Vivid dreams
|
13.8%
4/29
|
3.3%
1/30
|
|
Renal and urinary disorders
Increased urination
|
10.3%
3/29
|
0.00%
0/30
|
|
Nervous system disorders
Increased yawning
|
10.3%
3/29
|
3.3%
1/30
|
|
Nervous system disorders
Jittery
|
10.3%
3/29
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Increased sweating
|
10.3%
3/29
|
0.00%
0/30
|
|
Skin and subcutaneous tissue disorders
Chills
|
6.9%
2/29
|
0.00%
0/30
|
|
Psychiatric disorders
Depression
|
6.9%
2/29
|
3.3%
1/30
|
|
Infections and infestations
Fever
|
6.9%
2/29
|
0.00%
0/30
|
|
Vascular disorders
Hot flush
|
6.9%
2/29
|
0.00%
0/30
|
|
Gastrointestinal disorders
Increased appetite
|
6.9%
2/29
|
6.7%
2/30
|
|
Psychiatric disorders
Irritabililty
|
6.9%
2/29
|
13.3%
4/30
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.9%
2/29
|
6.7%
2/30
|
|
Musculoskeletal and connective tissue disorders
Muscle fasciculation
|
6.9%
2/29
|
0.00%
0/30
|
|
Gastrointestinal disorders
Abdominal pain
|
6.9%
2/29
|
0.00%
0/30
|
|
Infections and infestations
Sinus infection
|
6.9%
2/29
|
6.7%
2/30
|
|
Infections and infestations
Vaginal infection
|
6.9%
2/29
|
3.3%
1/30
|
|
Metabolism and nutrition disorders
Weight gain
|
6.9%
2/29
|
0.00%
0/30
|
Additional Information
Lesley M. Arnold, M.D.
University of Cincinnati College of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place