Design Considerations for a Phase II Platform Trial in Major Depressive Disorder.

ABSTRACT: Major depressive disorder (MDD) is one of the leading causes of disability globally. Despite its prevalence, approximately one-third of patients do not benefit sufficiently from available treatments, and few new drugs have been developed recently. Consequently, more efficient methods are needed to evaluate a broader range of treatment options quickly. Platform trials offer a promising solution, as they allow for the assessment of multiple investigational treatments simultaneously by sharing control groups and by reducing both trial activation and patient recruitment times. The objective of this simulation study was to support the design and optimisation of a phase II superiority platform trial for MDD, considering the disease-specific characteristics. In particular, we assessed the efficie

SUBMITTER: Freitag MM 

PROVIDER: S-EPMC12384050 | biostudies-literature | 2025 Sep-Oct

REPOSITORIES: biostudies-literature