Criste, I. Halvorsen, I. Cosgrove, L. Naudet, F. (2022). Lancet Psychiatry, Volume 9, ISSUE 12, P934-936, December 2022, DOI:https://doi.org/10.1016/S2215-0366(22)00340-6
Abstract:
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. 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. In trials conducted for the regulatory approval of drug-assisted psychotherapies, such as 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder (PTSD) and psilocybin-assisted therapy for treatment-resistant depression, there were no specific requirements for or an evaluation of the psychotherapy component. In the MDMA trial, both the treatment and the comparator groups received a bespoke psychological intervention, not previously tested in independently conducted randomised trials, instead of one of several evidence-based alternatives. Read more …