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  Vol. 66 No. 1, January 2009 TABLE OF CONTENTS
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Concomitant Use of Lorazepam With Tamoxifen in Bipolar Mania Clinical Trials—Reply

Aysegül Yildiz, MD; Dost Ongur, MD, PhD; Perry Renshaw, MD, PhD

Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

In reply

We read with interest the letter by Drs Kruszewski and Paczynski regarding our study of tamoxifen in acute mania. The letter first points to the 3-week duration, single-site nature, provision of "individualized" food and recreation, and worsening with placebo as weaknesses of our study. We respectfully disagree with this characterization for the following reasons. First, a duration of 3 weeks is in fact typical for acute mania trials (31 of 34 placebo-controlled monotherapy trials in acute mania conducted to date are of 3 weeks' duration) (A.Y., E. Vieta, MD, PhD, and R. J. Baldessarini, MD, unpublished data, August 15, 2008). Because of drug-placebo separation between days 7 and 21, 3 weeks has been suggested as an optimum duration for acute mania trials.1 Second, there is little literature on the impact of single-site designs in acute mania . . . [Full Text of this Article]


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