Adults 18 to 65, any sex, with Fatigue or Quality of Life. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Fatigue Severity Scale (FSS)Primary· Change will be assessed over a 10 week interval
This is a psychometrically validated self-report measure of fatigue. This measure consists of 11 items inquiring about the severity of fatigue in different situations during the past week. Scores for each item range from 1 to 7, where 1 indicates strong disagreement and 7 strong agreement. Higher scores indicate higher levels of fatigue. A responder on the FSS is an individual whose FSS total score has decreased by 0.7 its when compared baseline to week 10 (or last observation carried forward); 0.7 refers to the minimally clinical significant difference (MCID) in change over time. We report th
Group
Value
95% CI
8 Week Disulfiram
4
4 Week Disulfiram
2
Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)Primary· Change will be assessed over a 10 week interval
The Q-LES-Q - SF is a self-reported questionnaire, with 16 items evaluating overall enjoyment and satisfaction with physical health, mood, work, household and leisure activities, social and family relationships, daily functioning, sexual life, economic status, overall well-being and medications. Responses are scored on a 5-point scale, where higher scores indicate better enjoyment and satisfaction with life (possible range 14-70). Fourteen summated items create the total Q-LES-Q - SF score. Two last items, about medications and overall life satisfaction, are considered independently. Meaningfu
Group
Value
95% CI
8 Week Disulfiram
2
4 Week Disulfiram
2
The Short Form (36) Health Survey (SF-36) Physical Component Summary (PCS)Secondary· Change will be assessed over a 10 week interval
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. The 8 scales are-vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning mental health. Each scale is directly transformed into a 0-100 scale, the lower the score the more disability and the higher the score the less disability. We calculate the Physical Component Summary (PCS) (representing physical funct
Group
Value
95% CI
8 Week Disulfiram
-5.183
± 4.126
4 Week Disulfiram
-6.466
± 5.374
General Symptom Questionnaire (GSQ-30)- Assess Multisystemic Symptom BurdenSecondary· Change will be assessed over a 10 week interval
This is a psychometrically validated 30 item self-report measure of symptom burden. The measure asks participants to rate how bothered they have been with a particular symptom over a 2-week time frame. Responses are made on 5-point Likert scale ranging from "not at all" to "very much" (scored 0-4); and the total score ranges from 0-120. Higher scores indicate more symptom severity. We report the magnitude of the score change (week 10 or last observation carried forward (LOCF)) minus the baseline score; a positive change score indicates improvement.
Group
Value
95% CI
8 Week Disulfiram
25.6
± 12.402
4 Week Disulfiram
6.25
± 20.790
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Symptom Summary Score on Sleep Disturbance, Pain, Anxiety, Depression, and Low Energy/Fatigue (SPADE)Secondary· Change will be assessed over a 10 week interval
The PROMIS-29 is a psychometrically validated 29 item self-report measure covering 7 domains. The questions are ranked on a 5-point Likert Scale. The composite score on 5 symptoms of the 7 domains is known as the SPADE summary score (sleep disturbance, pain, anxiety, depression, and low energy/fatigue); this represents the most common chronic symptoms in the general population. Each domain has 5 response options (e.g., 1=not at all to 5=very much), with scale scores ranging from 4 to 20 and higher scores indicating worse symptom severity. Using the scores from these 5 domains, we calculated th
Group
Value
95% CI
8 Week Disulfiram
6.86
± 3.71
4 Week Disulfiram
5.95
± 5.15
The Short Form (36) Health Survey (SF-36) Mental Component Summary (MCS)Secondary· Change will be assessed over a 10 week interval
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. The 8 scales are-vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning mental health. Each scale is directly transformed into a 0-100 scale, the lower the score the more disability and the higher the score the less disability. We calculate the Mental Component Summary (MCS) (representing physical functio
Group
Value
95% CI
8 Week Disulfiram
-3.76
± 15.437
4 Week Disulfiram
-4.814
± 5.486
Adverse events — posted to ClinicalTrials.gov
Time frame: up to 14 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Approximately 10-20% of patients experience ongoing symptoms despite having received standard antibiotic therapy for Lyme disease. Possible explanations for persistent symptoms include persistent infection and/or post-infectious causes. Recent in vitro studies indicate that disulfiram is effective at killing both the actively replicating and the more quiescent persister forms of Borrelia burgdorferi, the microbe that causes Lyme Disease. In this study, the investigators are examining the safety of disulfiram among patients with post-treatment Lyme disease symptoms. The investigators are also conducting a preliminary investigation regarding the relative benefit of 4 vs 8 weeks of treatment with disulfiram.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04521335 — Study of Disulfiram and Copper Gluconate in Patients With Treatment-Refractory Multiple Myeloma
· Phase 1
· terminated
NCT04594343 — Clinical Study to Evaluate the Effects of Disulfiram in Patients With Moderate COVID-19
· Phase 2
· completed
NCT04502589 — Open Label Pilot Study of Perampanel for the Treatment of Alcohol Use Disorder
· Phase 1, PHASE2
· completed
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Currently open trials in the same condition.
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· NA
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NCT06819254 — Pilot Study of Fisetin to Improve Fatigue Among Older Adult Cancer Survivors
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Other Research Foundation for Mental Hygiene, Inc. trials
Trials by the same sponsor.
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· NA
· completed
NCT05826132 — Digital Mental Health Care for COVID-19 High-Risk Populations - Phase 2
· NA
· completed
NCT05818228 — Reducing Self-Stigma Among Individuals with History of Childhood Maltreatment
· NA
· completed
NCT05645042 — Transcendental Meditation in Veterans and First Responders With PTSD
· NA
· terminated
NCT05057624 — Gaze-Contingent Music Reward Treatment for PTSD
· NA
· withdrawn
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Research Foundation for Mental Hygiene, Inc.
Last refreshed: 9 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03891667.