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White Paper

Acceptance of Placebo-Controlled Trials in Acute Psychiatric Indications

Acceptance of Placebo-Controlled Trials in Acute Psychiatric Indications

Acceptance of Placebo-Controlled Trials in Acute Psychiatric Indications

IQVIA
Pages 11 Pages

Placebo-controlled trials remain central to evaluating psychiatric treatments but face ethical and regulatory challenges. Clinical equipoise allows placebo use only where no proven therapy exists or when justified by strong methodological reasons. Evidence shows high placebo response in depression (12–52%) and acute mania (35–40%), reinforcing their scientific value. Concerns can be addressed by safeguards such as mandatory short-term hospitalization, rescue medications, long-term open-label extensions, and ongoing safety monitoring. Regulatory acceptance improves when protocols emphasize patient protection, minimize harm, and provide comprehensive safety data.

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