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Concomitant Use of Lorazepam With Tamoxifen in Bipolar Mania Clinical Trials
Stefan P. Kruszewski, MD;
Richard Paczynski, MD
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In the 2008 March issue of the Archives, the Tohen commentary "Clinical Trials in Bipolar Mania: Implications in Study Design and Drug Development"1 addressed the merits of the study by Yildiz et al "Protein Kinase C Inhibition in the Treatment of Mania: Double-blind Placebo-Controlled Trial of Tamoxifen"2 that appeared in the same issue. After careful review, we would like to add words of caution to Tohen's conclusion that the report by Yildiz et al
supports the findings of the preclinical, genetic, and clinical studies that demonstrated the role of PKC [protein kinase C] in bipolar disorder . . .
and that the study
represents an example of . . . improved understanding of the pathophysiology of bipolar disorder. . . .1(p253)
Tohen counterbalances his positive commentary by revealing certain weaknesses in the Yildiz et al study: a short-term trial lasting 3 weeks; a single-site, single-rater study; "individualized" (and therefore uncontrolled) food and . . . [Full Text of this Article]
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RELATED ARTICLE
Clinical Trials in Bipolar Mania: Implications in Study Design and Drug Development
Mauricio Tohen
Arch Gen Psychiatry. 2008;65(3):252-253.
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RELATED LETTER
Concomitant Use of Lorazepam With Tamoxifen in Bipolar Mania Clinical Trials—Reply
Aysegül Yildiz, Dost Ongur, and Perry Renshaw
Arch Gen Psychiatry. 2009;66(1):108-109.
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