Schizophrenia drug development is at a crossroads. Placebo response in acute schizophrenia trials has been rising for decades while the observed treatment benefit is in decline, narrowing the gap between active treatment and placebo, making it harder to demonstrate statistical effect. A 2020 FDA review found that PANSS placebo response scores increased from -6.4 to -10.5 over 18 years, while study success rates fell from 78% to 57%. The result is a catalogue of drug failures where effective therapies may fail because the study cannot reliably detect their effect. The goal should not be to eliminate placebo response entirely, it should be to maximize detection of the true treatment effect through smarter trial design, better site selection, and emerging tools like AI-based predictive models.
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