Open‐label study with the monoamine stabilizer (‐)‐OSU6162 in myalgic encephalomyelitis/chronic fatigue syndrome, Haghighi et al, 2021

Discussion in 'ME/CFS research' started by Andy, Feb 3, 2021.

  1. Andy

    Andy Committee Member

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    Open access, https://onlinelibrary.wiley.com/doi/full/10.1002/brb3.2040
     
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  2. Jaybee00

    Jaybee00 Senior Member (Voting Rights)

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  3. leokitten

    leokitten Senior Member (Voting Rights)

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    This paper is definitely better than the Abilify retrospective paper, even though it too has limitations being single-arm open label. OSU6162 and Abilify are quite similar drugs and are dopamine and serotonin system stabilizers.

    What do people think about the various endpoints? I don’t feel I have enough experience on the various ratings scales to form an opinion, but they used a number of diverse endpoints.

    In 2017, some of the same group of Swedish researchers as this study conducted a small double-blind RCT of OSU6162

    https://www.s4me.info/threads/a-ran...-treatment-of-me-cfs-2017-nilsson-et-al.1439/

    But that RCT found a null result which I believe was due to a major flaw in their design, they gave the drug (or placebo) for only 2 weeks. Big mistake. Testimonials on Abilify show that it only starts to show results at 2 weeks, and benefits seem to continue to increase for weeks afterward.

    I believe that’s why they did this new study where they gave the drug for 12 weeks and had a higher dosage level (45 mg bid) than the earlier RCT. I really wish they had done this study as a double-blind RCT.
     
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