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Open NIH: Proof of concept trial on the effect of Ketamine on Fatigue Study

Discussion in 'Recruitment into current ME/CFS research studies' started by Sly Saint, Jul 17, 2021.

  1. Sly Saint

    Sly Saint Senior Member (Voting Rights)

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    full details
    https://www.cc.nih.gov/sites/nihinternet/files/internet-files/recruit/pdfs/20_fatigue.pdf

    (this pdf seems to have been created last year?)
     
    Invisible Woman, Hutan, Barry and 3 others like this.
  2. James Morris-Lent

    James Morris-Lent Senior Member (Voting Rights)

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    Obvious question - why Ketamine?

    Also the wording: "research study on fatigue...not a treatment study for fatigue..." - huh??
     
    JemPD, Snow Leopard, Michelle and 9 others like this.
  3. Invisible Woman

    Invisible Woman Senior Member (Voting Rights)

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    Could be they want to learn something about how ketamine works or affects certain systems in the body? Or just compare the reaction of ketamine to the "active" placebo?

    So, the research is addressing a treatment for something rather than any of the diseases listed?

    Given that I am assuming they are assuming that fatigue experienced by all those groups is
    a) the same symptom & I'm not sure it is
    &
    b) it has similar causes & I'm not at all convinced about that.

    It might be interesting to see if medication targeted at "fatigue" experienced by different groups yields different effects but that certainly doesn't sound like that's happening here.
     
  4. rvallee

    rvallee Senior Member (Voting Rights)

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    It's been found potentially useful for depression, although that hasn't actually panned out. You can make the rest of leap yourself, it's a very short hoppity-hop.
     
    JemPD, Michelle, alktipping and 6 others like this.
  5. Invisible Woman

    Invisible Woman Senior Member (Voting Rights)

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    Yes, that too & in more ways than one. It's also been known to cause it. A neighbour's grand daughter experimented with it during her first year and uni. That was a few decades ago now.

    She went from a bright young thing with everything ahead of her to suffering from very severe depression, unable to hold down a job or maintain a relationship.
     
    JemPD, Trish, Michelle and 4 others like this.
  6. 5vforest

    5vforest Senior Member (Voting Rights)

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    So they won't fund legitimate ME/CFS research, but they *will* lump us together with other completely unrelated conditions in an exploratory study on "fatigue"? OK.
     
  7. Snow Leopard

    Snow Leopard Senior Member (Voting Rights)

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    https://clinicalstudies.info.nih.gov/ProtocolDetails.aspx?id=20-NR-0003

    I don't understand why they think this. Both ketamine and midazolam will increase central fatigue. Edit - I think the expected mechanism is an analgesic effect... In the paper mentioned below, the authors speculate about AMPAR activation, by glutamate selectively binding those receptors instead of NDMA receptors (one difference between NDMARs and AMPARs is that the former has ion channels permeable to both calcium and sodium ions, whereas the latter is only permeable by sodium ions). But if we are to entertain that argument, then we also need to consider Kainate receptors and metabotropic glutamate receptors. (and I still don't know how this is supposed to decrease fatigue.) Ketamine is also associated with a transient increase in blood pressure and this may mediate some of the effect.

    The principal author wrote a 2015 narrative review discussing potential causes of cancer related fatigue, with the following diagram:
    crf.jpg
    https://pubmed.ncbi.nlm.nih.gov/25975676/

    You've probably seen something like this before, only with "Chronic Fatigue Syndrome" at the centre, because the ideas are the same. It's very non-specific and doesn't actually explain anything.

    On the trial description page, they cite a general article authored by Sharpe (that if being polite, I can only describe as speculative) and a trial of the effect of ketamine on fatigue in Bipolar patients, also authored by the principal author of the aforementioned trial.
    https://pubmed.ncbi.nlm.nih.gov/26807672/
    Note, they do discuss that the effect may be biased due to lack of an active placebo (and thus the results are simply reporting biases), hence the use of midazolam in the proposed trial.

    The good news is that in the proposed trial, they're not merely relying on questionnaires, but actigraphy as well, so there is less chance of a false positive result due to study biases.

    There was also a recent study of Ketamine for MS-related fatigue, with a null primary outcome, but a modest effect on a 28 day outcome:
    https://journals.sagepub.com/doi/abs/10.1177/1352458520936226
     
    Last edited: Jul 19, 2021
  8. cfsandmore

    cfsandmore Senior Member (Voting Rights)

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    This will count as spending research funding on ME/CFS. NIH is increasing spending on MECFS will be their comment when questioned. This is a big government playing a game.
     
  9. rvallee

    rvallee Senior Member (Voting Rights)

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    True but I'd frame this more as medicine playing a game, this decision is entirely out of the hands of politicians, it's made by medical professionals and scientists. Governments rely on advisers to make decisions, some they leave to the experts. The advice they are getting is this, wasting is a feature, not a bug.
     
    cfsandmore, JemPD and Peter Trewhitt like this.
  10. Wonko

    Wonko Senior Member (Voting Rights)

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    UK
    Pain is fatiguing, or at least quite draining.

    If, as it may do, ketamine reduces pain, then that would have an effect on energy levels/activity - appearing to help fatigue, when in reality it's done sod all about fatigue, just reduced pain.

    I really find it quite mystifying why 'experts' wouldn't know that ketamine can reduce pain, and that pain can cause people to have less oomph, so reducing it would, logically, give them more.

    Of course dosage would be critical, take too much and your asleep, or doing naughty things with axes. ;)
     

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