The subcutaneous esketamine KAP trial will draw published methodological critique (editorial or letter) demanding randomized/blinded confirmation before any regulatory claim.

A study combining esketamine (a nasal-spray anesthetic used as a psychedelic-assisted therapy) with talk therapy didn't randomly assign patients to different groups, which makes it impossible to tell whether the drug, the therapy, or both together caused any improvements. Other scientists are likely to write criticism in medical journals demanding a more rigorous test before anyone claims this works. This matters because weak study designs can lead doctors and patients to trust treatments that haven't really been proven.

Non-randomized adjunctive designs cannot separate drug from psychotherapy. My review experience says peer reviewers pounce on this exact confound within weeks.