Trial · NCT04141696

A Proof-of-Concept Trial on the Effect of Ketamine on Fatigue

NCT04141696, Phase 1, Phase 2, Completed, National Institute of Nursing Research (NINR); results first posted 2025-04-15

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Proof-of-Concept Trial on the Effect of Ketamine on Fatigue. Trials, record NCT04141696. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04141696

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Trial

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

Title: A Proof-of-Concept Trial on the Effect of Ketamine on Fatigue
NCT number: NCT04141696
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 10 participants, actual
Lead sponsor: National Institute of Nursing Research (NINR)
Conditions: Fatigue
Interventions: Ketamine, Midazolam
First posted: 2019-10-28
Last updated: 2025-04-15
Results first posted: 2025-04-15

Source ClinicalTrials.gov

Registered outcomes11

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

List	Outcome	Time frame	Description
Primary	Percentage Change in Self-reported Fatigue Visual Analog Scale (VAS) Scale	Baseline to three days post infusion for each study arm	Percentage change in self-reported Fatigue Visual Analog Scale (VAS) after a single intravenous dose of the study drug. The Fatigue VAS is a 0-100 mm scale widely used to assess fatigue in patients with chronic illness. Higher score indicates worse fatigue. Change in fatigue VAS scores measured as comparison of fatigue VAS scores collected at the first visit (baseline) and three days post infusion of study drug during each treatment arm (Ketamine, active comparator). Analysis is measured as the difference between day three score minus the baseline score, divided by the baseline score.
Secondary	Percentage Change in Self-reported Fatigue Visual Analog Scale (VAS) Scale - Day 7	Up to 7 days post infusion for each study drug	Percentage change in self-reported Fatigue Visual Analog Scale (VAS) after a single intravenous dose of the study drug. The Fatigue VAS is a 0-100 mm scale widely used to assess fatigue in patients with chronic illness. Higher score indicates worse fatigue. Change in fatigue VAS scores measured as comparison of fatigue VAS scores collected at the first visit (baseline) and seven days post infusion for each treatment arm (Ketamine, active comparator). Analysis is measured as the percentage change in day seven score minus the baseline score, divided by the baseline score.
Secondary	Areas Under the Curve (AUC) for Percentage Changes in Self-reported Fatigue VAS Score - Through Day 7	Up to 7 days post infusion for each study drug	Percentage change in self-reported Fatigue Visual Analog Scale (VAS) after a single intravenous dose of the study drug. The Fatigue VAS is a 0-100 mm scale widely used to assess fatigue in patients with chronic illness. Higher score indicates worse fatigue. Change in fatigue VAS scores measured as comparison of fatigue VAS scores collected at the first visit (baseline), and then 40, 80, 120, 230 minutes, and 1, 3, and 7 days post infusion for each treatment arm (Ketamine, active comparator). Analysis is measured as the areas under the curve.
Secondary	Mean Physical Activity Count Using Actigraphy	Day 7 post infusion	Mean physical activity count using actigraphy. Participants wore a portable device to monitor activity levels at day seven post infusion for each study drug. Analysis is measured as the mean of physical activity count on day seven post infusion for each treatment arm.
Secondary	Fatigue Level Measured by Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale	Day 7 post infusion	The Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale is a 13-item questionnaire that measures level of fatigue symptoms. Each item is rated on a scale of 0 (not al all) to 4 (very much) with total score ranging from 0 to 52. Lower score indicates greater fatigue. The Fatigue subscale was used to assess participant's level of fatigue at day seven post infusion for each study arm analyzed as the mean score.
Secondary	Patient Reported Outcome Measurement Information System (PROMIS) - Anxiety Domain	Day 7 post infusion	The Patient Reported Outcome Measurement Information System (PROMIS) profile is a self-reported questionnaire assessing quality of life in various domains. The anxiety domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher scores indicate more anxiety. Participants completed the computerized adaptive test version of PROMIS anxiety subscale on day seven post infusion and analyzed as mean score.
Secondary	Patient Reported Outcome Measurement Information System (PROMIS) - Depression Domain	Day 7 post infusion	The Patient Reported Outcome Measurement Information System (PROMIS) profile is a self-reported questionnaire assessing quality of life in various domains. The depression domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher score indicates worsening depression. Participants completed the computerized adaptive test version of PROMIS depression subscale on day seven post infusion and analyzed as mean score.
Secondary	Patient Reported Outcome Measurement Information System (PROMIS) - Fatigue Domain	Day 7 post infusion	The Patient Reported Outcome Measurement Information System (PROMIS) profile is a self-reported questionnaire assessing quality of life in various domains. The fatigue domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher score indicates worsening fatigue. Participants completed the computerized adaptive test version of PROMIS fatigue subscale on day seven post infusion and analyzed as mean score.
Secondary	Patient Reported Outcome Measurement Information System (PROMIS) - Sleep Disturbance Domain	Day 7 post infusion	The Patient Reported Outcome Measurement Information System (PROMIS) profile is a self-reported questionnaire assessing quality of life in various domains. The Sleep Disturbance domain is scored on a 5-point Likert scale and converted into standardized T-scores with a mean of 50 and a standard deviation of 10 based on a US general population. Higher scores indicate worsening sleep disturbance being measured. Participants completed the computerized adaptive test version of PROMIS sleep disturbance subscale on day seven post infusion and analyzed as mean score.
Secondary	Fatigue Level Measured by Fatigue Visual Analogue Scale	Day 7 post infusion	The fatigue visual analogue scale (VAS) provides a simple method to assess fatigue. The Fatigue VAS is a 0-100 mm scale with 0 (no fatigue at all) to 100 (extreme fatigue). Higher score indicates worsening fatigue. Fatigue VAS score collected from all participants on day seven post infusion for each treatment arm and analyzed as mean score.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage Change in Self-reported Fatigue Visual Analog Scale (VAS) Scale	Baseline to three days post infusion for each study arm	All participants who completed the study.	Percentage change	MEDIAN
SECONDARY	Percentage Change in Self-reported Fatigue Visual Analog Scale (VAS) Scale - Day 7	Up to 7 days post infusion for each study drug	All participants who completed the study.	Percentage of change	MEAN
SECONDARY	Areas Under the Curve (AUC) for Percentage Changes in Self-reported Fatigue VAS Score - Through Day 7	Up to 7 days post infusion for each study drug	All participants who completed the study.	Percentage change*minutes	MEAN
SECONDARY	Mean Physical Activity Count Using Actigraphy	Day 7 post infusion	All participants who completed the study.	Count of activity	MEAN
SECONDARY	Fatigue Level Measured by Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale	Day 7 post infusion	All participants who completed the study.	Units on a scale	MEAN
SECONDARY	Patient Reported Outcome Measurement Information System (PROMIS) - Anxiety Domain	Day 7 post infusion	All participants who completed the study.	T Score	MEAN
SECONDARY	Patient Reported Outcome Measurement Information System (PROMIS) - Depression Domain	Day 7 post infusion	All participants who completed the study.	T Score	MEAN
SECONDARY	Patient Reported Outcome Measurement Information System (PROMIS) - Fatigue Domain	Day 7 post infusion	All participants who completed the study.	T Score	MEAN
SECONDARY	Patient Reported Outcome Measurement Information System (PROMIS) - Sleep Disturbance Domain	Day 7 post infusion	All participants who completed the study.	T Score	MEAN
SECONDARY	Fatigue Level Measured by Fatigue Visual Analogue Scale	Day 7 post infusion	All participants who completed the study.	Units on a scale	MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group22

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

Outcome	Group	Value	Spread	Units
Percentage Change in Self-reported Fatigue Visual Analog Scale (VAS) Scale	Ketamine Administration	-21.0	Inter-Quartile Range -28.2 to -7.0	Percentage change
Percentage Change in Self-reported Fatigue Visual Analog Scale (VAS) Scale	Midazolam Administration	-12.6	Inter-Quartile Range -27.5 to -6.3	Percentage change
Percentage Change in Self-reported Fatigue Visual Analog Scale (VAS) Scale - Day 7	Ketamine Administration	-32.7	Standard Deviation 33.9	Percentage of change
Percentage Change in Self-reported Fatigue Visual Analog Scale (VAS) Scale - Day 7	Midazolam Administration	-19.6	Standard Deviation 22.4	Percentage of change
Areas Under the Curve (AUC) for Percentage Changes in Self-reported Fatigue VAS Score - Through Day 7	Ketamine Administration	497411	Standard Deviation 239346	Percentage change*minutes
Areas Under the Curve (AUC) for Percentage Changes in Self-reported Fatigue VAS Score - Through Day 7	Midazolam Administration	518668	Standard Deviation 250584	Percentage change*minutes
Mean Physical Activity Count Using Actigraphy	Ketamine Administration	57.5	Standard Deviation 37.0	Count of activity
Mean Physical Activity Count Using Actigraphy	Midazolam Administration	70.4	Standard Deviation 35.8	Count of activity
Fatigue Level Measured by Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale	Ketamine Administration	33.8	Standard Deviation 6.43	Units on a scale
Fatigue Level Measured by Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scale	Midazolam Administration	33.1	Standard Deviation 6.92	Units on a scale

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Period 1	STARTED	Ketamine Then Midazolam Administration	4
Period 1	STARTED	Midazolam Then Ketamine Administration	4
Period 1	COMPLETED	Ketamine Then Midazolam Administration	4
Period 1	COMPLETED	Midazolam Then Ketamine Administration	4
Period 1	NOT COMPLETED	Ketamine Then Midazolam Administration	0
Period 1	NOT COMPLETED	Midazolam Then Ketamine Administration	0
Period 2	STARTED	Ketamine Then Midazolam Administration	4
Period 2	STARTED	Midazolam Then Ketamine Administration	4
Period 2	COMPLETED	Ketamine Then Midazolam Administration	4
Period 2	COMPLETED	Midazolam Then Ketamine Administration	4

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events94

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	Arrhythmia	Cardiac disorders	Ketamine Administration	0	8
other	Arrhythmia	Cardiac disorders	Midazolam Administration	1	8
other	Bradycardia	Cardiac disorders	Ketamine Administration	0	8
other	Bradycardia	Cardiac disorders	Midazolam Administration	1	8
other	Palpitations	Cardiac disorders	Ketamine Administration	1	8
other	Palpitations	Cardiac disorders	Midazolam Administration	0	8
other	Dry mouth	Gastrointestinal disorders	Ketamine Administration	2	8
other	Dry mouth	Gastrointestinal disorders	Midazolam Administration	0	8
other	Nausea	Gastrointestinal disorders	Ketamine Administration	3	8
other	Nausea	Gastrointestinal disorders	Midazolam Administration	0	8

1 to 10 of 94Source ClinicalTrials.gov

See all 94 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ketamine Administration	0	8
Total, all-cause mortality	Midazolam Administration	0	8
Total, other adverse events	Ketamine Administration	8	8
Total, other adverse events	Midazolam Administration	8	8
Total, serious adverse events	Ketamine Administration	0	8
Total, serious adverse events	Midazolam Administration	0	8

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
12202331	BACKGROUND	PubMed
26807672	BACKGROUND	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 comparisons2

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

Comparison	Source
Ketamine Administration vs Midazolam Administration: deaths from any cause	Trial comparisons
Ketamine Administration vs Midazolam Administration: 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.

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