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This phase 2b randomized clinical trial evaluated liafensine, a triple reuptake inhibitor, in patients with treatment-resistant depression who tested positive for the ANK3 pharmacogenomic biomarker. Of 1,967 patients screened, 189 ANK3-positive participants were randomized to once-daily liafensine 1 mg (n=62), liafensine 2 mg (n=62), or placebo (n=64); 188 received treatment, and 186 had at least one postrandomization efficacy assessment. The primary endpoint was change in MADRS total score from baseline to day 42. At week 6, mean MADRS scores decreased by 15.4 points (SE, 0.9) with the combined liafensine doses compared with 11.0 points (SE, 1.3) with placebo, yielding a treatment difference of −4.4 points (95% CI, −7.6 to −1.3; P=0.006; Cohen d=0.42). The individual doses also significantly improved MADRS scores versus placebo, with a treatment difference of −4.4 points for 1 mg (95% CI, −7.9 to −0.8; P=0.02; Cohen d=0.41) and −4.5 points for 2 mg (95% CI, −8.1 to −0.9; P=0.02; Cohen d=0.44). Secondary outcomes favoured liafensine, including Clinical Global Impression–Severity scores (treatment difference, −0.4; 95% CI, −0.8 to −0.1; nominal P=0.02) and Sheehan Disability Scale scores (difference, −2.4; 95% CI, −4.8 to −0.1; nominal P=0.04). Adverse events leading to treatment discontinuation occurred in 5 liafensine-treated participants (4.0%) and 9 placebo recipients (14.1%). Liafensine significantly improved depressive symptoms in this biomarker-selected population, supporting further investigation of pharmacogenomic approaches to treatment selection; however, independent replication and phase 3 evaluation are needed before routine clinical use
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This phase 2b randomized clinical trial evaluated liafensine, a triple reuptake inhibitor, in patients with treatment-resistant depression who tested positive for the ANK3 pharmacogenomic biomarker. Of 1,967 patients screened, 189 ANK3-positive participants were randomized to once-daily liafensine 1 mg (n=62), liafensine 2 mg (n=62), or placebo (n=64); 188 received treatment, and 186 had at least one postrandomization efficacy assessment. The primary endpoint was change in MADRS total score from baseline to day 42. At week 6, mean MADRS scores decreased by 15.4 points (SE, 0.9) with the combined liafensine doses compared with 11.0 points (SE, 1.3) with placebo, yielding a treatment difference of −4.4 points (95% CI, −7.6 to −1.3; P=0.006; Cohen d=0.42). The individual doses also significantly improved MADRS scores versus placebo, with a treatment difference of −4.4 points for 1 mg (95% CI, −7.9 to −0.8; P=0.02; Cohen d=0.41) and −4.5 points for 2 mg (95% CI, −8.1 to −0.9; P=0.02; Cohen d=0.44). Secondary outcomes favoured liafensine, including Clinical Global Impression–Severity scores (treatment difference, −0.4; 95% CI, −0.8 to −0.1; nominal P=0.02) and Sheehan Disability Scale scores (difference, −2.4; 95% CI, −4.8 to −0.1; nominal P=0.04). Adverse events leading to treatment discontinuation occurred in 5 liafensine-treated participants (4.0%) and 9 placebo recipients (14.1%). Liafensine significantly improved depressive symptoms in this biomarker-selected population, supporting further investigation of pharmacogenomic approaches to treatment selection; however, independent replication and phase 3 evaluation are needed before routine clinical use
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