Consistency of the Antidepressant Effect of Intranasal Esketamine in Phase 3 Clinical Trials
Journal of Psychiatric Practice March 1, 2021 Sheldon H. Preskorn 3 citations
This column reviews the development of intranasal esketamine, focusing on the consistency of clinical trial results. It illustrates methodological issues important to the U.S. Food and Drug Administration approval process, including study design, the nature of the comparator, and the prespecified statistical analysis plan. The column discusses what constitutes a positive versus a supportive study, differences between phase 2 and phase 3 studies, and the rationale for including both in development. While especially relevant to intranasal esketamine, it also serves as a general example of drug development and approval.