Today’s research published in World Psychiatry shows that patients with severe depression who use antidepressants are underrepresented in clinical trials. This means we have relatively little knowledge about the treatment effects of antidepressants in the real world.
Clinical trials (RCTs) form the basis of current clinical treatment guidelines for depression. However, these studies exclude many patients because of their strict selection criteria, which means that the results may not always be representative of the people treated in clinical practice. For the first time for depression, it has now been examined to what extent the people with depression in the real world are represented in such research. In this large-scale study, researchers investigated how many people with major depressive disorder (MDD) who use antidepressants in routine care would not be eligible to participate in RCTs.
The researchers, led by psychiatrist Jurjen Luykx, with contributions from prof. dr. Christiaan Vinkers, and prof. dr. Brenda Penninx from Amsterdam UMC, analysed data from over 200,000 adults with MDD who use antidepressants. Using a standardised list of selection criteria, they determined who would and would not be eligible to participate in RCTs. They then examined hospital admissions, psychiatric problems, suicide attempts, mortality, and changes in treatment in these adults over a six month period.
Findings
The study shows that one third to half of the patients with depression would not qualify to participate in RCTs, mainly due to physical and psychiatric conditions. Moreover, the group that would be excluded had more than twice the risk of severe outcomes, such as hospital admissions or suicide attempts, compared with the group that would be eligible for RCTs.
These findings demonstrate that current RCTs do not always provide an accurate picture of the broad population of patients who use antidepressants in clinical practice. The authors therefore argue for broader selection criteria for RCTs, and a better integration of scientific research with real-world clinical data. So that treatment guidelines better reflect the reality of people living with depression. This could ultimately help make the treatment of depression more personalized and better suited to individual patients’ needs.