The study, with the participation of Clínic-IDIBAPS researchers, examined data from health records in Finland and Sweden including over 200,000 people with major depression and undergoing maintenance antidepressant treatment.
The results are clear: over a third of patients in real clinical practice did not meet the inclusion criteria for regular clinical trials, which usually exclude people with medical comorbidities, other psychiatric disorders, or substance use. In some cases, the proportion was even higher when broader definitions for somatic disorders were applied.
According to the study, those patients who would be excluded from clinical trials face more than twice the risk of psychiatric hospitalisation, attempted suicide, or death during the six months of follow-up, compared to those who would be eligible to participate.
For Joaquim Raduà, head of the IDIBAPS Imaging of mood- and anxiety-related disorders (IMARD) research group and co-author of the study, these results highlight a structural problem: “Clinical trials are essential. However, they often exclude the more complex patients that we also deal with every day, who often have needs that are not as well covered. This means that the clinical guidelines are based on data that, in part, do not reflect the reality of many people with depression. This situation can limit the adaptation of treatments to the circumstances of the most vulnerable patients."
According to Eduard Vieta, head of the Clínic Psychiatry and Psychology Service and leader of the IDIBAPS Bipolar and depressive disorders group: “We advocate the designing of trials with less restrictive inclusion criteria, the extending of the follow-up periods, and the systematic integration of data from actual clinical practice to ensure that clinical recommendations are applicable to the diversity of profiles of patients with major depression.”
