TY  - JOUR
T1  - INappropriate data and measures lead to questionable conclusions
AU  - Spielmans GI, Jureidini J, Healy D, Purssey R
Y1  - 2013/01/01
N1  - 10.1001/jamapsychiatry.2013.747
JO  - JAMA Psychiatry
SP  - 121
EP  - 123
VL  - 70
IS  - 1
N2  - 
Though their article purported to include data regarding patients with major depressive disorder, not all trials included patients with a primary diagnosis of depression. For example, in the LYAQ fluoxetine trial, participants either (1) met DSM-IV criteria for attention-deficit/hyperactivity disorder and had concurrent anxious/depressive symptoms or (2) met criteria for an anxiety or depressive disorder and had concurrent attention-deficit/hyperactivity disorder symptoms. Further, all participants taking fluoxetine were also taking atomoxetine hydrochloride, rendering the trial incapable of assessing potential fluoxetine-related suicidality; thus, this study does not provide evidence regarding either the efficacy or safety of fluoxetine relative to placebo.3 We would have gladly combed through descriptions of the remaining studies to assess for similar problems, but most of them are difficult or impossible to obtain. Readers should not have to attempt a search of manufacturer clinical trial databases, which are far from inclusive, to find basic descriptions of included studies; at the very least, for each included trial, a clearer description of participants' diagnoses, concurrent treatment, reports of suicide-related events, and change on depression rating scales is needed to better understand the nature of the data underlying the claims of Gibbons et al.

SN  - 2168-622X
M3  - doi: 10.1001/jamapsychiatry.2013.747
UR  - http://dx.doi.org/10.1001/jamapsychiatry.2013.747
ER  -