28 Of two monotherapy trials for acute depression, only one found significantly greater improvement on the primary outcome 23 ; in the other, the efficacy of LTG compared with placebo approached significance based on LOCF with a dose of 200 mg/day, but not 50 mg/day. 20 There is little published data on efficacy for acute mania, and no strong evidence from placebo-controlled trials.
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Efficacy and safety of lamotrigine in the treatment of bipolar disorder across the lifespan: a systematic review.
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No significant differences in response rate at 16 weeks were found between any of the groups (LTG 23%, risperidone 6.4%, inositol 17.4%), despite a positive trend in favour of LTG.
These results were reflected in the p values for manic/mixed and depressive relapse which did not reach statistical significance and led the authors to conclude that the data did not support LTG monotherapy for either indication.