Trial · NCT00375973

Double Blind Trial of Duloxetine in Chronic Fatigue Syndrome

NCT00375973, Phase 2, Phase 3, Completed, University of Cincinnati; results first posted 2015-07-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Double Blind Trial of Duloxetine in Chronic Fatigue Syndrome. Trials, record NCT00375973. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00375973

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Double Blind Trial of Duloxetine in Chronic Fatigue Syndrome
NCT number: NCT00375973
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 60 participants, actual
Lead sponsor: University of Cincinnati
Conditions: Fatigue Syndrome, Chronic
Interventions: Duloxetine, Placebo
First posted: 2006-09-13
Last updated: 2015-08-21
Results first posted: 2015-07-27

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Multidimensional Fatigue Inventory (MFI)--General Fatigue Subscale Score	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.
Secondary	Change From Baseline in Brief Pain Inventory (BPI) --Average Pain Severity Score	Baseline to endpoint at 12 weeks	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).
Secondary	Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) --Depression Subscale	baseline to endpoint at 12 weeks	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.
Secondary	Change From Baseline in the Clinical Global Impression of Severity (CGI-S)	baseline to endpoint at 12 weeks	Clinician rated assessment of severity on a 1 (normal)-7 (extremely ill) scale. A decrease in the score indicates improvement.
Secondary	Patient Global Impression of Improvement (PGI-I)	baseline to endpoint at 12 weeks.	Patient rated assessment of change on a 1 (very much better) to 7 (very much worse) scale.
Secondary	Number of Participants Who Discontinued the Study for Any Reason	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.
Secondary	Number of Participants Who Discontinued Use of Treatment Due to Adverse Events	Any time after randomization up to 12 weeks.	Paticipants who dropped out of the study because of intolerable adverse events.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Multidimensional Fatigue Inventory (MFI)--General Fatigue Subscale Score	Baseline to endpoint at 12 weeks	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.	units on a scale	MEAN
SECONDARY	Change From Baseline in Brief Pain Inventory (BPI) --Average Pain Severity Score	Baseline to endpoint at 12 weeks	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.	units on a scale	MEAN
SECONDARY	Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) --Depression Subscale	baseline to endpoint at 12 weeks	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.	units on a scale	MEAN
SECONDARY	Change From Baseline in the Clinical Global Impression of Severity (CGI-S)	baseline to endpoint at 12 weeks	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.	units on a scale	MEAN
SECONDARY	Patient Global Impression of Improvement (PGI-I)	baseline to endpoint at 12 weeks.	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.	units on a scale	MEAN
SECONDARY	Number of Participants Who Discontinued the Study for Any Reason	Any time after randomization up to 12 weeks.		participants	NUMBER
SECONDARY	Number of Participants Who Discontinued Use of Treatment Due to Adverse Events	Any time after randomization up to 12 weeks.	One patient in the duloxetine group did not have post-baseline data.	participants	NUMBER

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Multidimensional Fatigue Inventory (MFI)--General Fatigue Subscale Score	Duloxetine	-3.3	Standard Deviation 4.2	units on a scale
Change From Baseline in Multidimensional Fatigue Inventory (MFI)--General Fatigue Subscale Score	Placebo	-1.8	Standard Deviation 2.8	units on a scale
Change From Baseline in Brief Pain Inventory (BPI) --Average Pain Severity Score	Duloxetine	-1.6	Standard Deviation 1.5	units on a scale
Change From Baseline in Brief Pain Inventory (BPI) --Average Pain Severity Score	Placebo	-0.8	Standard Deviation 2.3	units on a scale
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) --Depression Subscale	Duloxetine	-1.6	Standard Deviation 2.9	units on a scale
Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) --Depression Subscale	Placebo	-1.9	Standard Deviation 3.0	units on a scale
Change From Baseline in the Clinical Global Impression of Severity (CGI-S)	Duloxetine	-1.1	Standard Deviation 1.2	units on a scale
Change From Baseline in the Clinical Global Impression of Severity (CGI-S)	Placebo	-0.4	Standard Deviation 1.0	units on a scale
Patient Global Impression of Improvement (PGI-I)	Duloxetine	3.2	Standard Deviation 1.2	units on a scale
Patient Global Impression of Improvement (PGI-I)	Placebo	3.3	Standard Deviation 1.2	units on a scale

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Duloxetine	30
Overall Study	STARTED	Placebo	30
Overall Study	COMPLETED	Duloxetine	20
Overall Study	COMPLETED	Placebo	28
Overall Study	NOT COMPLETED	Duloxetine	10
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events60

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nausea	Gastrointestinal disorders	Duloxetine	19	29
other	Nausea	Gastrointestinal disorders	Placebo	6	30
other	Somnolence	Nervous system disorders	Duloxetine	12	29
other	Somnolence	Nervous system disorders	Placebo	3	30
other	dizziness	Nervous system disorders	Duloxetine	9	29
other	dizziness	Nervous system disorders	Placebo	2	30
other	headache	Nervous system disorders	Duloxetine	3	29
other	headache	Nervous system disorders	Placebo	12	30
other	dry mouth	Gastrointestinal disorders	Duloxetine	6	29
other	dry mouth	Gastrointestinal disorders	Placebo	1	30

1 to 10 of 60Source ClinicalTrials.gov

See all 60 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Duloxetine
Total, all-cause mortality	Placebo
Total, other adverse events	Duloxetine	29	29
Total, other adverse events	Placebo	30	30
Total, serious adverse events	Duloxetine	1	29
Total, serious adverse events	Placebo	0	30

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25660434	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Duloxetine vs Placebo: Number of Participants Who Discontinued Use of Treatment Due to Adverse Events	Trial comparisons
Duloxetine vs Placebo: Number of Participants Who Discontinued the Study for Any Reason	Trial comparisons
Duloxetine vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00375973

GET https://conductscience.org/api/trials/v1/NCT00375973/events?page=2

API reference For AI assistants