Asset profile

Forvisirvat

Small molecule

Negativelead readout

Evidence outlook · lead readout

NCT04479852 · Major Depressive Disorder

The lead readout missed its primary endpoint. The grade and rationale below record what the trial was designed to show and what it found.

NCT04479852: The study randomized 319 participants to SP-624 or placebo and used quadruple masking, with 132 SP-624 and 125 placebo participants included in the primary analysis. Its clinical primary endpoint, change in MADRS score at Week 4, was not statistically significant (p=0.133), so the results provide well-controlled but inconclusive evidence of benefit.

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