Trial Outcomes & Findings for A Proof-of-Concept Trial on the Effect of Ketamine on Fatigue (NCT NCT04141696)

10 participants were consented and two were screen failure so were not randomized in the study.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Hamilton Depression (HAM-D) utilizes a 21-item, clinician-rated paper questionnaire that measures the severity of depressive symptoms of the participants in the past week prior to the interview though only the first 17 items are used in scoring. Depending on the item, it is scored between 0 (not present) and 4 (severe) points using either a three-point or a five-point scale and summed up to obtain the total score. The HAM-D comprises 17 items, of which 9 are evaluated on a five-point scale (0-4) and 8-on a three-point scale (0-2). The total score range from 0 to the maximum score 52 on a 17-item scale, with higher scores indicating more serious depression. Total scores of 0-7 are considered as normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression. Data was collected from all participants on day seven post infusion for each treatment arm and analyzed as mean score.