MAt least five patients would need to be screened to enroll just one patient meeting the typical inclusion and exclusion criteria for antidepressant registration trials (ARTs), suggests the new research by Drs. Sheldon Preskorn and Matthew Macaluso of University of Kansas School of Medicine-Wichita and Dr. Madhukar Trivedi of Southwestern Medical School, Dallas. The study highlights some major differences between patients with depression seen in everyday clinical practice and those enrolled in ARTs–the studies of antidepressants that lead to FDA drug approval.
Most Patients with Major Depression Aren’t Eligible for ARTs
Antidepressant registration trials use certain inclusion and exclusion criteria to create a group of patients with similar characteristics. These criteria increase the chances of detecting true drug effects, while reducing “false signals” of safety problems or side effects. For example, ARTs commonly exclude patients with other medical problems–if their illness worsened during the study, it might raise inaccurate safety concerns about the drug being studied.
To find out how these inclusion and exclusion criteria affect patient selection for ARTs, the researchers analyzed more than 4,000 patients from the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study. Funded by the National Institute of Mental Health, STAR*D was the largest and longest study of depression treatment ever conducted. To ensure that the “real world” population of patients with depression was represented, STAR*D used minimal exclusion criteria.