Assessing Onset of Treatment Benefit in Depression and Anxiety: Conceptual Considerations
J Clin Psychiatry 2009;70(8):1138-1145
© Copyright 2015 Physicians Postgraduate Press, Inc.
Purchase This PDF for $40.00
If you are not a paid subscriber, you may purchase the PDF.
(You'll need the free Adobe Acrobat Reader.)
Receive immediate full-text access to JCP. You can subscribe to JCP online-only ($86) or print + online ($156 individual).
With your subscription, receive a free PDF collection of the NCDEU Festschrift articles. Hurry! This offer ends December 31, 2011.
If you are a paid subscriber to JCP and do not yet have a username and password, activate your subscription now.
As a paid subscriber who has activated your subscription, you have access to the HTML and PDF versions of this item.
Click here to login.
Did you forget your password?
Still can't log in? Contact the Circulation Department at 1-800-489-1001 x4 or send email
Objective: Methods for characterizing the
onset of treatment benefit in major depressive
disorder and generalized anxiety disorder have been studied for some time, yet there is no universal agreement as to the best approaches. Our purpose is to summarize the conceptual framework underlying modern methods for characterizing onset and detailed approaches for which there is consensus from the perspective of a clinician, clinical researcher, and statistician. Possible alternatives
to unresolved issues are discussed.
Participants: There were 17 experts from academia, the pharmaceutical industry, and the US Food and Drug Administration who met on April 19, 2007, to consider the issues. Many others from sponsoring firms observed the proceedings.
Evidence: A series of papers was presented
at a consensus meeting and, after discussions, a sense of the participants was obtained. A small group subsequently reviewed the material and
articles from the literature and prepared this article, which was reviewed by all of the participants.
Conclusions: The elements that form the basis for describing onset of treatment benefit include defining a clinical event or measurable threshold that validly signals that a treatment has begun to provide clinically meaningful and sustained improvement and utilizing methods for estimating the probability of crossing the onset threshold, the distribution of time to onset for those who do cross, and when to alter or change interventions if the treatment is unsuccessful.
Submitted: February 11, 2009; accepted April 21, 2009.
Corresponding author: Eugene M. Laska, PhD, Nathan S. Kline Institute for Psychiatric Research, 140 Old Orangeburg Rd, Orangeburg, NY 10962 (email@example.com).