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Implications in Study Design and Drug Development

Mauricio Tohen, MD, DrPH

Arch Gen Psychiatry. 2008;65(3):252-253.

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

In this issue of the Archives, Yildiz et al¹ report a 3-week, randomized, double-blind, placebo-controlled clinical trial to determine the antimanic efficacy of the centrally active protein kinase C (PKC) inhibitor tamoxifen citrate. The study was conducted in the inpatient psychiatric unit of a university medical center in Izmir, Turkey, and included 35 patients randomly assigned to tamoxifen and 31 to placebo. Patients were aged 18 to 60 years; had a diagnosis of bipolar disorder, currently in a manic or mixed state, with or without psychotic features (based on the Structured Clinical Interview for DSM-IV); and had Young Mania Rating Scale (YMRS) scores of more than 20 at baseline. Use of concomitant lorazepam was allowed up to 5 mg/d throughout the 3-week study duration. The study was completed by 83% of patients randomly assigned to tamoxifen and 68% of those who received placebo. Tamoxifen-treated patients . . . [Full Text of this Article]

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Concomitant Use of Lorazepam With Tamoxifen in Bipolar Mania Clinical Trials
Stefan P. Kruszewski and Richard Paczynski
Arch Gen Psychiatry. 2009;66(1):107-108.
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Protein Kinase C Inhibition in the Treatment of Mania: A Double-blind, Placebo-Controlled Trial of Tamoxifen
Aysegül Yildiz, Sebnem Guleryuz, Donna Pauler Ankerst, Dost Öngür, and Perry F. Renshaw
Arch Gen Psychiatry. 2008;65(3):255-263.
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THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Concomitant Use of Lorazepam With Tamoxifen in Bipolar Mania Clinical Trials
Kruszewski and Paczynski
Arch Gen Psychiatry 2009;66:107-108.
FULL TEXT