NSI-189: what does this study show?
220 adults with major depressive disorder randomized to oral NSI-189 40 mg daily, 80 mg daily or placebo for 12 weeks.
Neither dose significantly improved the primary clinician-rated depression outcome versus placebo. Some secondary self-report and cognitive measures favored 40 mg, but the Cogstate cognitive test did not. Both doses were described as well tolerated.
Secondary signals do not reverse the negative primary result. Findings in depression do not establish enhancement in healthy adults.
These findings apply to the population and methods described above.
What might this mean, and what would change the interpretation?
Secondary signals do not reverse the negative primary result. Findings in depression do not establish enhancement in healthy adults.
What would clarify this: Independent replication with clinically meaningful outcomes and longer safety follow-up.
Findings reviewed · abstract
Checked Sep 23, 2026 against the linked abstract. This reading note is not a formal risk-of-bias appraisal.