A Randomized Double Blind Placebo Controlled Trial of Lurasidone in Improving Cognitive Impairment in Euthymic Patients With Bipolar Disorder

Background 5-HT7 receptor antagonists have been shown to modulate cognitive function in pre-clinical studies. In a pilot RCT, we have previously demonstrated that lurasidone add-on significantly improves cognitive function in patients with bipolar disorder (BD) compared with treatment as usual. Aims & Objectives in a large RCT, we assessed the efficacy of lurasidone vs placebo adjunctive therapy in improving cognitive function in euthymic patients with BD who had cognitive impairment at study entry. Method 100 patients with BD were recruited and randomized to lurasidone or placebo adjunctive therapy from Canada, Japan, the US and the UK. All patients were euthymic at study entry and had cognitive impairment at least 0.5 SD below the expected norm. Primary outcome was composite cognitive score change from baseline to end point using the ISBD-BANC. Results Of the 100 recruited, 2 dropped out without completing the post-baseline ISBD-BANC, leaving 98 eligible patients for analysis. Majority of patients were recruited from 5 sites in Japan, Vancouver and London. The results are being analyzed and will be presented at the conference. Discussion & Conclusions ​This will be the first large double blind RCT to assess the efficacy of Lurasidone in euthymic bipolar patients. The results will provide important insights into the role of 5-HT7 receptor antagonists in cognition.