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This randomized clinical trial evaluated LB-102, an investigational antipsychotic, in 359 adults with acute schizophrenia assigned to placebo or one of three dose groups. After four weeks, the mean reduction in Positive and Negative Syndrome Scale (PANSS) total score was 9.3 points with placebo, compared with 14.3 points with LB-102 50 mg (\(p<0.001\); Hedges’ \(g=0.61\)) and 14.0 points with 75 mg (\(p=0.002\); Hedges’ \(g=0.41\)). The 100-mg group showed a reduction of 16.1 points, although this dose was not included in the formal multiplicity-controlled primary comparison. Treatment-emergent adverse events occurred in 69% of participants receiving 50 mg, 57% receiving 75 mg, 75% receiving 100 mg and 56% receiving placebo. The trial demonstrated short-term efficacy, but longer-term studies are needed to establish durability, comparative effectiveness and safety.
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This randomized clinical trial evaluated LB-102, an investigational antipsychotic, in 359 adults with acute schizophrenia assigned to placebo or one of three dose groups. After four weeks, the mean reduction in Positive and Negative Syndrome Scale (PANSS) total score was 9.3 points with placebo, compared with 14.3 points with LB-102 50 mg (\(p<0.001\); Hedges’ \(g=0.61\)) and 14.0 points with 75 mg (\(p=0.002\); Hedges’ \(g=0.41\)). The 100-mg group showed a reduction of 16.1 points, although this dose was not included in the formal multiplicity-controlled primary comparison. Treatment-emergent adverse events occurred in 69% of participants receiving 50 mg, 57% receiving 75 mg, 75% receiving 100 mg and 56% receiving placebo. The trial demonstrated short-term efficacy, but longer-term studies are needed to establish durability, comparative effectiveness and safety.
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