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Concomitant Use of Lorazepam With Tamoxifen in Bipolar Mania Clinical Trials—Reply
Ay egül Yildiz, MD;
Dost Ongur, MD, PhD;
Perry Renshaw, MD, PhD
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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trials in acute mania conducted to date are of 3 weeks' duration) (A.Y., E. Vieta, MD, PhD, and R. J. Baldessarini, MD, unpublished data, August 15, 2008).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] AUTHOR INFORMATION
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