Efficacy and Safety of Seltorexant as Adjunctive Therapy in Major Depressive Disorder: A Phase 2b, Randomized, Placebo-Controlled, Adaptive Dose-Finding Study.

Nevertheless, it is noteworthy that the sigE max model approached significance, indicating a potential plateauing of effects at the seltorexant 20-mg and 40-mg doses; this prespecified model profile provided the closest fit to the actual results, in which 20 mg showed clearly greater efficacy than 10 mg (which showed no benefit) and a trend toward greater efficacy than 40 mg (which showed modest evidence of benefit) on the mean change in MADRS scores.

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The study did not achieve significance in its primary analysis of MCP Mod because the pre-specified models did not fit the actual observed dose-response relationship characterized by better outcomes with the seltorexant 20-mg dose than the 40-mg dose.

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