FDA Shakes Up Guidance on Antidepressant Trial Design


From MedPage Today: “The FDA released new draft guidance for development and testing new pharmacologic agents indicated to treat major depressive disorder (MDD).

For example, the new guidance offers specifics on testing the emerging classes of rapid-action antidepressants such as ketamine and its analogues. It also notes that because placebo effects in depression are so strong, traditional non-inferiority trials comparing two active drugs are impossible, and thus all trials of new agents must include a placebo group.

The FDA is currently accepting comments and suggestions on this draft over the next 60 days.”

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