February 21, 2020 | Medscape
Suicidal Patients Often Excluded From Antidepressant Trials
Clinical trials of antidepressants that inform US Food and Drug Administration (FDA) approval decisions often exclude suicidal patients, leaving clinicians uncertain of the efficacy of these drugs in this patient population, new research shows.
Commenting on the study for Medscape Medical News, Dominic Sisti, PhD, director of the Scattergood Program for Applied Ethics in Behavioral Health Care at the University of Pennsylvania in Philadelphia, called the exclusion of individuals with suicidality from antidepressant research "an issue of justice."
"Individuals with serious, even terminal medical conditions are not excluded from potentially beneficial research without a specific reason [and] when mental illness is correctly understood as equivalent to medical illness, the default exclusion of suicidal people in antidepressant research appears to be arbitrary and unjustified."
Sisti, who was not involved with the study, added that many researchers "may be unaware that the FDA has stated that suicidal ideation or behavior need not be exclusion criteria in psychiatric research."