Besides apprising us of the height at which FDA currently sets the bar for approval of new drugs in psychiatry, the recent approval of the s-enantiomer of ketamine for treatment-resistant depression provides grist for conjecture about what may be an increasing resemblance between criteria for approval of prescription drugs, which traditionally have required compelling evidence (before approval) of both safety … Read the rest
This review, published on line by the FDA reviewers who voted (without unanimity) to approve esketamine for treatment-resistant depression (Jean Kim and colleagues, New England Journal of Medicine, published on line, ahead of print, on July 4, 2019), illustrates potential adversity that may devolve from confirmation bias with good intentions. We do not know whether the authors submitted it … Read the rest
Little is known about long-term outcome of persons diagnosed with and treated for attention deficit/hyperactivity disorder (ADHD) in childhood or adolescence.
That approximately half of the children and adolescents who begin stimulant pharmacotherapy are no longer receiving it ten years later broaches a possibility that ADHD may represent a self-limited anomaly of neurodevelopment—a normal variant that some youth “out-grow.” … Read the rest
The authors of this 39-site, Janssen-sponsored, double-blind, placebo-controlled study (Vanina Popova and colleagues, American Journal of Psychiatry 176:6:428-438, 2019) submitted its findings to FDA in support of its (now successful) application for approval of intranasal S-ketamine (Esketamine) for treatment-resistant depression.
A structural and pharmacodynamic analogue of phencyclidine (PCP), S-ketamine is withal documented to act across a broad spectrum … Read the rest
While a preponderance of studies of antidepressant-treated bipolar depression have observed equivocal long-term outcomes characterized by non-robust antidepressant response and insufficient reprise of quality of life, a recent English-language study, published in a Polish medical journal by University of Pennsylvania researcher Jay Amsterdam and Indiana University colleague L. Lorenzo-Luaces (JD. Amsterdam and L. Lorenzo-Luaces, Psychiatria Polska 52(6):957-969, 2019), attributes diminishing … Read the rest