Digital Mental Health: A Narrative Review of FDA-Authorized Products for Psychiatric Treatment and Diagnostic Support

Brain Sci · 2026 · PMC13296681

Europe PMC

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did not reach statistical significanceno p-value reported

Evidence: In Phase 3’s randomized controlled trial (the Mirai study; N = 386 ITT, n = 354 mITT), the primary mITT analysis showed a MADRS reduction of 9.03 points with Rejoyn versus 7.25 points with sham (difference −1.78; p = 0.057), which did not reach statistical significance.

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