Clinical studies are a cornerstone of bringing safe, effective drugs for major depressive disorder (MDD) to market. In both the US and the EU, regulators require randomized, double-blind, placebo controlled, parallel group studies to demonstrate short-term efficacy for acute MDD. Long-term studies may also be required to demonstrate that initial response to treatment is maintained or to assess the ability of the investigational product to reduce the rate of recurrence of depression. Due to their larger size, duration, and scope, these maintenance studiers require careful planning and disciplined execution.
In this guide, we explore key considerations to designing and operationalizing maintenance studies to evaluate the long-term efficacy and safety of drugs to treat MDD.