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In the second monotherapy study (Frye et al 2000) (Table 2), lamotrigine was compared with gabapentin and placebo in a double-blind, randomized, crossover trial on 31 patients with refractory unipolar and bipolar affective illness requiring hospitalization. The diagnostic distribution of these patients was 6 unipolar illness, 11 bipolar I and 14 bipolar II disorder, the majority of the bipolar group (23 out of 25) had a rapid cycling course. Patients were randomized, with stratification by diagnostic classification, to receive sequential 6-week trials of each of the 3 treatment arms. Maximum tolerated doses of lamotrigine and gabapentin were used with mean daily doses being 274 mg and 3987 mg, respectively. Using the CGI for bipolar illness as primary outcome measure, 52% of the lamotrigine group had a rating of вmuch improvedв or вvery much improvedв, compared with 26% of the gabapentin and 23% of the placebo groups (p = 0.031). When response rates were analysed by affective episode types, both mania (lamotrigine 44%, gabapentin 20%, placebo 32%) and depression (lamotrigine 45%, gabapentin 26%, placebo 19%) showed similar non-significant trends. In an extension to this study with a bigger sample size (N = 45), of which there were 35 bipolar and 10 unipolar treatment-refractory patients, response rates of 53% for lamotrigine, 28% for gabapentin and 22% for placebo (p = 0.01), were reported (Obrocea et al 2002). Response to lamotrigine monotherapy was significantly correlated with a diagnosis of bipolar disorder, the male gender, exposure to fewer prior medication trials and a history of fewer prior hospitalizations for depression, although only the last two survived logistic regression. 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