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NCT04141696 · ClinicalTrials.gov registry record · Phase 1
A Proof-of-Concept Trial on the Effect of Ketamine on Fatigue
A Phase 1 study of Fatigue, sponsored by National Institute of Nursing Research (NINR).
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT04141696 is a Phase 1 study of Fatigue that has completed, run by National Institute of Nursing Research (NINR). The registered enrollment target is 10 participants, below the 218-participant average among 109 other Fatigue trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04141696, a Phase 1 study of Fatigue, has completed, sponsored by National Institute of Nursing Research (NINR).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Many people experience fatigue as a side effect of their illnesses and treatments. There are no medicines to treat fatigue, but a drug called ketamine has reduced fatigue in depressed people. Researchers hope that ketamine, compared to a drug called midazolam, can reduce fatigue in people with illnesses. Objective: To test whether ketamine reduces fatigue in cancer survivors and people with chronic illness. Eligibility: Adults between the ages of 18 and 70 who have fatigue and are cancer survivors or have been diagnosed with a chronic illness such as chronic fatigue syndrome and lupus. Design: Participants will be screened with a physical exam, medical history, blood and urine tests, questions about their fatigue, and breathalyzer test. During phase 1, participants will complete rating their fatigue using questionnaires. They will be provided thinking, memory, and motivation tests. They will also take a handgrip test. For this study, the participant will have an IV, which a needle guides a thin plastic tube (intravenous or IV line) into an arm in their vein. An IV will be required for two of the visits. They will get a single dose of either ketamine or midazolam through an IV line over 40 minutes. Participants must be accompanied by a responsible friend/family/colleague to take them home after getting the study drug. Participants will have follow-up visits where they repeat the above tests. They will also have follow-up phone calls. Phase 2 is the same as phase 1, but participants get the other study drug. The study lasts 1 month. Each phase lasts 2 weeks. Participants will have 6-8 total NIH visits. For the whole study, they will wear a device on their wrists that records physical activity. Drug side effects can include vivid dreams, seeing colors, perceiving time as moving slower or faster than normal, dizziness, headache, restlessness, nausea, or vomiting, among others.
Conditions Studied
Interventions
- DRUG Ketamine
- DRUG Midazolam
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-07-26 |
| Est. Completion | 2024-03-21 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04141696
The ClinicalTrials.gov registry entry for NCT04141696 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 218-participant average among 109 other Fatigue trials with a reported enrollment target (95% lower). The listed sponsor is National Institute of Nursing Research (NINR), which has 46 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Fatigue appearing as the primary indexed condition, and to 2 interventions - of which Ketamine is the first listed.
NCT04141696 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT04141696 about?
NCT04141696 is a clinical study titled "A Proof-of-Concept Trial on the Effect of Ketamine on Fatigue". Background: Many people experience fatigue as a side effect of their illnesses and treatments. There are no medicines to treat fatigue, but a drug called ketamine has reduced fatigue in depressed people. Researchers hope that ketamine, compared to a drug called midazolam, can reduce fatigue in peop...
What is the current status of trial NCT04141696?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2021-07-26. Estimated completion is 2024-03-21.
What conditions does trial NCT04141696 study?
This clinical trial studies the following conditions: Fatigue.
What interventions are being tested in trial NCT04141696?
The interventions under investigation include: Ketamine (DRUG), Midazolam (DRUG).
Who is sponsoring clinical trial NCT04141696?
This trial is sponsored by National Institute of Nursing Research (NINR), which has 46 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04141696 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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