Representation and outcomes of individuals with major depression in routine care who are ineligible for randomized controlled trials: a nationwide register‐based study

作者：Aleksi Hamina, Justo Pinzón‐Espinosa, Heidi Taipale, Johannes Schneider‐Thoma, J. Radua, Orestis Efthimiou, Narcis Cardoner, Christoph U. Correll, Paolo Fusar‐Poli, E. Mittendorfer‐Rutz, Brenda W.J.H. Penninx, Henricus G. Ruhe, Antti Tanskanen, C. Vinkers, S Leucht, Eduard Vieta, Cipriani Andrea, J. Tiihonen, Jurjen J. Luykx · 发表于：World Psychiatry · 年份：2026 · DOI：10.1002/wps.70013 · 被引用次数：5 · 研究领域：Treatment of Major Depression、Advanced Causal Inference Techniques、Mental Health Treatment and Access

Randomized controlled trials (RCTs) are the foundation of current clinical treatment guidelines. However, they may not reflect real-world populations, due to strict eligibility criteria. We determined the proportion of individuals with major depressive disorder (MDD) receiving maintenance antidepressant treatment in routine care who would be ineligible for RCTs, and compared their outcomes with those who were eligible. Utilizing specialized health care registers in Finland (2004-2018) and Sweden (2006-2021), we identified adults diagnosed with non-psychotic MDD (ICD-10: F32, F33) who were stabilized on maintenance antidepressant monotherapy. Through multidisciplinary expert consensus on latest meta-analytic evidence, we derived a standardized list of RCT inclusion and exclusion criteria. These criteria were systematically applied to classify individuals as RCT-eligible or RCT-ineligible. We then used Cox proportional models to derive hazard ratios (HRs) of a composite primary outcome of hospitalization due to any psychiatric reason or suicide attempt, and all-cause mortality, during a 6-month follow-up. Secondary outcomes were treatment changes (i.e., discontinuation, switch or augmentation) and psychiatric sick leave ≥2 weeks. A total of 73,720 individuals in Finland and 135,092 in Sweden were included. More than one third of patients with MDD (33.5% in Finland and 35.3% in Sweden) were found to be ineligible for RCTs. The most common reasons for ineligibility were comorbidi...