Abstract
The first trial was not a randomised controlled trial and was designed to answer the question what happens to people with depression who are treated with citalopram in routine clinical practice and what are the important prognostic indicators.1 The potential participants were 4041 outpatients aged 18–75 with DSM-IV defined non-psychotic major depressive disorder referred into the trial by their clinicians. Participants were recruited from 41 clinical sites in the USA which involved 18 primary care clinics (38% of participants) and 23 specialty psychiatric settings (62% of participants). People were not eligible if they had already had an adequate trial of the treatments in the first two levels of the STAR*D study. Of the 4041 potential participants, 1165 were excluded because they either did not meet the study requirements of having “moderate” depression—that is, a score on the 17-item HAM-D of 14 or more, (931 people) or they chose not to participate, leaving 2876 in the trial. Of these, two thirds were women with an average age of 41; for 25% the current episode of depression had lasted for at least two years; and 18% had a history of attempted suicide. Of note here is that a major incentive for patients taking part in this trial is that they got free healthcare within their local health system.

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