- Jul 2018
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europepmc.org europepmc.org
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On 2014 Oct 26, Nicholas Rosenlicht commented:
In evaluating the results of this trial it is important to note that the published results do not correspond to the primary outcomes specified in the trial’s original and updated registrations on ClinicalTrials.gov. The four primary outcome measures initially registered (10/7/2008) were: MADRS at 40 minutes, 120 minutes, 24 hours, and 7 days. These were expanded on 1/12/11 to include the MADRS at 240 minutes, 48 hours, 72 hours, biweekly for up to 4 weeks, and early termination. After publication (1/30/14) all Primary Outcomes except MADRS at 24 hours were removed from the ClincalTrials.gov registration. These changes can be tracked at: http://clinicaltrials.gov/archive/NCT00768430 It would be important to understand why the authors changed the outcome measures several times during the trial. These changes are not mentioned in the publication. The finding that ketamine, a dissociative anesthetic that is abused for its euphoric and other mind-altering properties, transiently suppresses MADRS scores is not surprising. It would be much more important clinically to demonstrate significant effects on the outcome measures at 2 to 4 weeks. These were not presented.
This comment, imported by Hypothesis from PubMed Commons, is licensed under CC BY.
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- Feb 2018
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europepmc.org europepmc.org
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On 2014 Oct 26, Nicholas Rosenlicht commented:
In evaluating the results of this trial it is important to note that the published results do not correspond to the primary outcomes specified in the trial’s original and updated registrations on ClinicalTrials.gov. The four primary outcome measures initially registered (10/7/2008) were: MADRS at 40 minutes, 120 minutes, 24 hours, and 7 days. These were expanded on 1/12/11 to include the MADRS at 240 minutes, 48 hours, 72 hours, biweekly for up to 4 weeks, and early termination. After publication (1/30/14) all Primary Outcomes except MADRS at 24 hours were removed from the ClincalTrials.gov registration. These changes can be tracked at: http://clinicaltrials.gov/archive/NCT00768430 It would be important to understand why the authors changed the outcome measures several times during the trial. These changes are not mentioned in the publication. The finding that ketamine, a dissociative anesthetic that is abused for its euphoric and other mind-altering properties, transiently suppresses MADRS scores is not surprising. It would be much more important clinically to demonstrate significant effects on the outcome measures at 2 to 4 weeks. These were not presented.
This comment, imported by Hypothesis from PubMed Commons, is licensed under CC BY.
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