—Drs Kravitz and Fawcett point out some of the design issues that arise in clinical research on bipolar disorder. We elected to include patients without consideration of their prior treatment response. One reason for this is that for purposes of inclusion/exclusion criteria, establishing prior response to treatment is confounded by numerous factors (eg, compliance, adequacy of dosing, and recency of prior treatment) that, taken in the aggregate, weaken prior treatment response as an explicit criterion. Also, the effectiveness of divalproex compared with placebo had been demonstrated in a sample of patients who were refractory to lithium, so it was important to determine the efficacy in a more generally representative sample.1 The percentage assessed as having benefited from lithium is somewhat higher in this study than in the two other recent controlled clinical trials that reported this information; one study reported 46%2 and the other 41%3
Bowden CL. Efficacy of Divalproex vs Lithium and Placebo in Mania-Reply. JAMA. 1994;272(13):1006. doi:10.1001/jama.1994.03520130039028
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