How many subjects with major depressive disorder meet eligibility requirements of an antidepressant efficacy trial?
OBJECTIVE
To evaluate the generalizability of the results of antidepressant efficacy trials by determining how many subjects with DSM-IV major depressive disorder who apply for entry into such trials are ultimately enrolled.


METHODS
The screening results of 378 subjects who inquired about participating in 1 of 2 separate antidepressant efficacy trials performed at Rhode Island Hospital between 1997 and 2002 were reviewed. The number of subjects who enrolled, as well as the reasons for exclusion of those who did not meet eligibility requirements, were determined.


RESULTS
Of the 378 inquiries, 186 subjects expressed interest and received a current major depressive disorder diagnosis. From this sample, 27 (14.5%) were ultimately enrolled in 1 of the 2 antidepressant trials. The most common reasons for exclusion were bipolar disorder (17.2%), drug or alcohol abuse (15.6%), mild depression (14.0%), medical contraindication (12.9%), and the use of prohibited psychotropic medications (12.4%).


CONCLUSIONS
The majority of subjects with major depressive disorder who apply to participate in an antidepressant efficacy trial do not meet eligibility requirements. When prescribing antidepressants, clinicians should bear in mind that the results of these trials may only be directly applicable to a small subset of patients treated in clinical practice.
Keitner
Gabor I
GI
Department of Psychiatry and Human Behavior, Brown University School of Medicine, Rhode Island Hospital, 593 Eddy St., Providence, RI 02903, USA. gkeitner@lifespan.org
Posternak
Michael A
MA
Ryan
Christine E
CE
D000928:Antidepressive Agents / Q000627:therapeutic use*; D015897:Comorbidity; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D004311:Double-Blind Method; D004608:Eligibility Determination / Q000706:statistics & numerical data; D006801:Humans; D010352:Patient Dropouts / Q000706:statistics & numerical data; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D012189:Retrospective Studies; D012237:Rhode Island; D016896:Treatment Outcome
D000928:Antidepressive Agents