A reanalysis in BMJ challenged the original findings of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study by the National Institute of Mental Health (NIMH), suggesting significant protocol violations in the STAR*D data. The STAR*D study initially reported a cumulative remission rate of 67% after up to four antidepressant treatments. However, the BMJ analysis adjusted this figure to 35%, using protocol-stipulated criteria, thereby halving the reported efficacy. This revelation potentially necessitates a review and possible revision of clinical practices and policies established based on the original STAR*D findings.

The BMJ reanalysis, part of the Restoring Invisible and Abandoned Trials initiative, scrutinized the STAR*D level 1 data provided by the NIMH. The authors noted crucial deviations from the original protocol, such as the inclusion of patients who should have been excluded and the use of a non-blinded primary outcome measure contrary to the predefined blinded Hamilton Rating Scale for Depression. These findings suggest that the actual effectiveness of standard antidepressant therapies might be lower than previously thought, emphasizing the need for continued research and development of novel treatments for depression.

Reference: Miller J. STAR*D Dethroned? Psychiatric Times. Published December 12, 2023. Accessed March 22, 2024. https://www.psychiatrictimes.com/view/star-d-dethroned