MSGID: 1:317/3 64b220f3   
   PID: hpt/lnx 1.9.0-cur 2019-01-08   
   TID: hpt/lnx 1.9.0-cur 2019-01-08   
    Ketamine effective for treatment-resistant depression, study suggests   
      
      
     Date:   
         July 14, 2023   
     Source:   
         University of New South Wales   
     Summary:   
         Promising results in a trial of ketamine for severe depression   
         could lead to treatment becoming more affordable.   
      
      
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   A low-cost version of ketamine to treat severe depression has performed   
   strongly in a double-blind trial that compared it with placebo.   
      
   In research published today in the British Journal of Psychiatry,   
   researchers led by UNSW Sydney and the affiliated Black Dog Institute   
   found that more than one in five participants achieved total remission   
   from their symptoms after a month of bi-weekly injections, while a   
   third had their symptoms improve by at least 50 per cent. The study   
   was a collaboration between six academic clinical mood disorder units   
   in Australia and one in New Zealand and was funded by the Australian   
   National Health and Medical Research Council (NHMRC).   
      
   "For people with treatment-resistant depression -- so those who have   
   not benefitted from different modes of talk-therapy, commonly prescribed   
   antidepressants, or electroconvulsive therapy -- 20 per cent remission   
   is actually quite good," lead researcher Professor Colleen Loo says.   
      
   "We found that in this trial, ketamine was clearly better than the   
   placebo - - with 20 per cent reporting they no longer had clinical   
   depression compared with only 2 per cent in the placebo group. This is   
   a huge and very obvious difference and brings definitive evidence to   
   the field which only had past smaller trials that compared ketamine with   
   placebo."  How the trial worked The researchers recruited 179 people with   
   treatment-resistant depression. All were given an injection of either a   
   generic form of ketamine that is already widely available in Australia as   
   a drug for anaesthesia and sedation -- or placebo. Participants received   
   two injections a week in a clinic where they were monitored for around two   
   hours while acute dissociative and sedative effects wore off -- usually   
   within the first hour. The treatment ran for a month and participants were   
   asked to assess their mood at the end of the trial and one month later.   
      
   As a double-blind trial, neither participants nor researchers   
   administering the drug were aware which patients received generic ketamine   
   or placebo, to ensure psychological biases were minimised. Importantly,   
   a placebo was chosen that also causes sedation, to improve treatment   
   masking. Midazolam is a sedative normally administered before a general   
   anaesthetic, while in many previous studies the placebo was saline.   
      
   "Because there are no subjective effects from the saline, in previous   
   studies it became obvious which people were receiving the ketamine and   
   which people received placebo," Prof. Loo says.   
      
   "In using midazolam -- which is not a treatment for depression, but does   
   make you feel a bit woozy and out of it -- you have much less chance   
   of knowing whether you have received ketamine, which has similar acute   
   effects."  Other features of the recent trial that set it apart from   
   past studies included accepting people into the trial who had previously   
   received electroconvulsive therapy (ECT).   
      
   "People are recommended ECT treatment for their depression when all   
   other treatments have been ineffective," Prof. Loo says.   
      
   "Most studies exclude people who have had ECT because it is very hard   
   for a new treatment to work where ECT has not."  Another difference about   
   this trial was that the drug was delivered subcutaneously (injected into   
   the skin) rather than by drip, thus greatly reducing time and medical   
   complexity. The study is also the largest in the world to date that   
   compares generic ketamine with placebo in treating severe depression.   
      
   Much more affordable Apart from the positive results, one of the standout   
   benefits of using generic ketamine for treatment-resistant depression   
   is that it is much cheaper than the patented S-ketamine nasal spray   
   currently in use in Australia. Where S-ketamine costs about $800 per dose,   
   the generic ketamine is a mere fraction of that, costing as little as $5,   
   depending on the supplier and whether the hospital buys it wholesale. On   
   top of the cost for the drug, patients need to pay for the medical care   
   they receive to ensure their experience is safe -- which at Black Dog   
   Institute clinics, comes to $350 per session.   
      
   "With the S-ketamine nasal spray, you are out of pocket by about $1200   
   for every treatment by the time you pay for the drug and the procedure,   
   whereas for generic ketamine, you're paying around $300-350 for the   
   treatment including the drug cost," Prof. Loo says.   
      
   She adds that for both S-ketamine and generic ketamine treatments, the   
   positive effects often wear off after a few days to weeks, so ongoing   
   treatment may be required, depending on someone's clinical situation. But   
   the prohibitive costs of the drug and procedure make this an unsustainable   
   proposition for most Australians.   
      
   "This is why we're applying for a Medicare item number to fund this   
   treatment now, because it's such a powerful treatment.   
      
   "And if you consider that many of these people might spend many months   
   in hospital, or be unable to work and are often quite suicidal, it's   
   quite cost effective when you see how incredibly quickly and powerfully   
   it works. We've seen people go back to work, or study, or leave hospital   
   because of this treatment in a matter of weeks."  The researchers will   
   next be looking at larger trials of generic ketamine over longer periods,   
   and refining the safety monitoring of treatment.   
      
   Participating trial sites   
       * UNSW / Black Dog Institute * Royal Prince Alfred Hospital /   
       University of Sydney * NeuroCentrix Research Institute * Royal   
       Adelaide Hospital / University of Adelaide * Monash Alfred Psychiatry   
       Research Centre / Monash University * University of Otago * Gold   
       Coast University Hospital   
   Institutions of non-site collaborators   
       * Deakin University * University of Newcastle * The George Institute   
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   Materials provided by University_of_New_South_Wales. Original written   
   by Lachlan Gilbert. Note: Content may be edited for style and length.   
      
      
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   Journal Reference:   
      1. Colleen Loo, Nick Glozier, David Barton, Bernhard T. Baune,   
      Natalie T.   
      
         Mills, Paul Fitzgerald, Paul Glue, Shanthi Sarma, Veronica   
         Galvez-Ortiz, Dusan Hadzi-Pavlovic, Angelo Alonzo, Vanessa Dong,   
         Donel Martin, Stevan Nikolin, Philip B. Mitchell, Michael Berk,   
         Gregory Carter, Maree Hackett, John Leyden, Sean Hood, Andrew   
         A. Somogyi, Kyle Lapidus, Elizabeth Stratton, Kirsten Gainsford,   
         Deepak Garg, Nicollette L. R. Thornton, Ce'lia Fourrier, Karyn   
         Richardson, Demi Rozakis, Anish Scaria, Cathrine Mihalopoulos,   
         Mary Lou Chatterton, William M. McDonald, Philip Boyce, Paul   
         E. Holtzheimer, F. Andrew Kozel, Patricio Riva-Posse, Anthony   
         Rodgers. Efficacy and safety of a 4-week course of repeated   
         subcutaneous ketamine injections for treatment-resistant depression   
         (KADS study): randomised double-blind active-controlled trial. The   
         British Journal of Psychiatry, 2023; 1 DOI: 10.1192/bjp.2023.79   
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   Link to news story:   
   https://www.sciencedaily.com/releases/2023/07/230714114752.htm   
      
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