Category Archives: Evidence Review

An opioid adjunct for treatment-resistant depression

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

Confirmation bias and esketamine approval

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

Partial Tolerance to Methylphenidate in ADHD?

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

Olanzapine for Anorexia Nervosa

With the arguable exception of clozapine, olanzapine confers the highest risk of weight gain, obesity, and metabolic adverse effects among the second-generation, atypical neuroleptics. Yet, might that adverse effect become a therapeutic one in persons with anorexia nervosa? So wondered clinical researchers Evelyn Attia and colleagues, of Columbia University (American Journal of Psychiatry 176:6:449-456, 2019), who randomly and … Read the rest

Ketamine: antidepressant or opioid mood-elevator?

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