New treatments for mental disorders should be routinely compared to psychotherapy in trials conducted for regulatory purposes

Treatments for mental disorders stem from various intervention classes, such as pharmacological, psychosocial, and physical. However, whereas drugs, biologics, and devices are formally regulated by public agencies, such as the US Food and Drug Administration or the European Medicines Agency, psychotherapies are largely unregulated.1 We are concerned that regulatory trials for the treatment of mental disorders exclude or do not evaluate psychotherapies, even when one is ostensibly a constituent of the combination therapy submitted for approval.