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How to Optimize Success in Clinical Trials of Antidepressants
By Paula Jacobsen, Ph.D., and Nick DeMartinis, M.D., Praxis Precision Medicines
This is an exceptionally exciting time to be developing therapies for patients suffering from depressive disorders. Advances in antidepressant pharmacology have led to diverse and promising therapeutic options. However, it is important to acknowledge the challenges of conducting clinical trials for major depressive disorder (MDD).
Chief among these challenges is the sensitivity of clinical trial methodology for demonstration of efficacy in MDD. A meta-analysis of antidepressant programs that included FDA-approved antidepressant clinical trial data from randomized, double-blind, placebo-controlled acute treatment studies conducted between 1995 and 2008 revealed that only 50% were successful despite the inclusion of only studies that evaluated doses in the approved therapeutic range.