Restoring STAR*D: A Reanalysis of Drug-Switch Therapy After Failed SSRI Treatment Using Patient-Level Data with Fidelity to the Original STAR*D Research Protocol.

ABSTRACT:

Background

The Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial was designed to give guidance in selecting the best next-step treatment for depressed patients who did not remit during their first, and/or subsequent, antidepressant trial, with up to four trials per patient. Our prior research documented protocol violations which inflated STAR*D's reported cumulative remission rate by 91.4%. A similar reanalysis of the step-2 drug-switch trial has not been done until now.

Methods

We reanalyzed the patient-level dataset of STAR*D's drug-switch treatment therapies-with fidelity to the original research protocol and related publications-to determine whether there were clinically-relevant differences in results compared to the original publicatio

SUBMITTER: Xu C 

PROVIDER: S-EPMC11844611 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature