Ketamine for Fatigue
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether ketamine, a medication known for easing fatigue in people with depression, can also reduce fatigue in cancer survivors and individuals with chronic illnesses such as chronic fatigue syndrome and lupus. Participants will receive either ketamine or midazolam (a comparison drug) to determine which is more effective at reducing fatigue. Ideal participants are adults who have experienced persistent fatigue for at least six months and have either survived cancer or been diagnosed with a chronic illness. As a Phase 1 trial, the research focuses on understanding how the treatment works in people.
Will I have to stop taking my current medications?
Yes, you may need to stop taking certain medications. The trial does not allow the use of some psychiatric medications, certain non-psychiatric medications, and any drugs known to interact with ketamine or midazolam. If you are on any of these medications, you may need to stop them 14 days before the study and during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that ketamine has been safely used as an anesthetic in medical settings for many years. While it can cause side effects such as vivid dreams, dizziness, or nausea, these effects are usually mild and temporary. No evidence indicates serious long-term health risks when ketamine is used under medical supervision.
Midazolam, often used to aid relaxation, is also generally safe. It can cause sleepiness or fatigue, especially immediately after administration. However, healthcare professionals typically ensure it is well-tolerated. There is a small risk of slowed breathing, but this is rare unless combined with certain other drugs.
Both ketamine and midazolam have a history of safe use in medical treatments, with side effects manageable in a controlled environment like a clinical trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using ketamine for treating fatigue because it offers a unique mechanism of action compared to traditional options. Most fatigue treatments rely on lifestyle changes or stimulants to boost energy levels temporarily. In contrast, ketamine is an NMDA receptor antagonist and is thought to work by modulating glutamate, a neurotransmitter involved in mood and cognition, which might offer more sustained relief. Additionally, ketamine has shown rapid effects in other conditions such as depression, suggesting it could provide quicker results for fatigue compared to conventional treatments. This potential for fast-acting relief and a novel approach to managing fatigue makes ketamine a promising candidate that researchers are keen to explore further.
What evidence suggests that ketamine might be an effective treatment for fatigue?
Research has shown that ketamine can reduce tiredness in people with certain conditions. One study found that ketamine noticeably reduced tiredness within 40 minutes, with the strongest effects by the second day. It lowered tiredness levels compared to a placebo from 40 minutes after treatment and continued to do so for up to 14 days. Another study found that ketamine also improved pain and physical function for up to six months. In this trial, participants will receive both ketamine and midazolam in different sequences. Midazolam, primarily used for sedation, does not have known effects on reducing tiredness. This suggests that ketamine might be more effective for reducing tiredness.678910
Who Is on the Research Team?
Leorey N Saligan, C.R.N.P.
Principal Investigator
National Institute of Nursing Research (NINR)
Are You a Good Fit for This Trial?
Adults aged 18-70 with chronic fatigue due to cancer survival or illnesses like lupus, who've had persistent fatigue for over six months. They must be able to consent and have someone accompany them post-drug infusion. Women of childbearing age should use effective birth control.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Phase 1
Participants receive a single dose of either ketamine or midazolam through an IV line over 40 minutes, followed by assessments including fatigue questionnaires, cognitive tests, and physical activity monitoring.
Washout
A two-week washout period where no active treatment is administered to allow the effects of the first drug to dissipate.
Treatment Phase 2
Participants receive the alternate study drug (either ketamine or midazolam) through an IV line over 40 minutes, followed by similar assessments as in Phase 1.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including follow-up visits and phone calls.
What Are the Treatments Tested in This Trial?
Interventions
- Ketamine
- Midazolam
- Midazolam (placebo)
Ketamine is already approved in United States, European Union, Canada for the following indications:
- Anesthesia
- Treatment-resistant depression
- Anesthesia
- Treatment-resistant depression
- Treatment-resistant depression
- Treatment-resistant depression
- Treatment-resistant depression
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Nursing Research (NINR)
Lead Sponsor