, Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM), FDA. Briefing Information for the February, vol.12, 2019.

, Joint Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM), FDA. Briefing Information for the November, vol.2, 2018.

U. Administration and . Breakthrough, , 2018.

S. Meltzer-brody, H. Colquhoun, and R. Riesenberg, Brexanolone injection in postpartum depression: two multicentre, double-blind, randomised, placebo-controlled, phase 3 trials, The Lancet, vol.392, pp.1058-70, 2018.

C. R. Conway, M. S. George, and H. A. Sackeim, Toward an Evidence-Based, Operational Definition of Treatment-Resistant Depression: When Enough Is Enough, JAMA Psychiatry, vol.74, issue.1, pp.9-10, 2017.

A. Cipriani, T. A. Furukawa, and G. Salanti, Comparative efficacy and acceptability of 21 antidepressant drugs for the acute treatment of adults with major depressive disorder: a systematic review and network meta-analysis, The Lancet, vol.391, pp.1357-66, 2018.

S. J. Curry, A. H. Krist, and D. K. Owens, Interventions to Prevent Perinatal Depression: US Preventive Services Task Force Recommendation Statement, Jama, vol.321, issue.6, pp.580-587, 2019.

J. A. Kopec, M. Abrahamowicz, and J. M. Esdaile, Randomized discontinuation trials: utility and efficiency, Journal of clinical epidemiology, vol.46, issue.9, pp.959-71, 1993.

S. Stephens, E. Ford, P. Paudyal, and H. Smith, Effectiveness of Psychological Interventions for Postnatal Depression in Primary Care: A Meta-Analysis, Annals of family medicine, vol.14, issue.5, pp.463-72, 2016.

S. Van-bronswijk, N. Moopen, L. Beijers, H. G. Ruhe, and F. Peeters, Effectiveness of psychotherapy for treatment-resistant depression: a meta-analysis and meta-regression, Psychological Medicine, vol.49, issue.3, pp.366-79, 2019.

R. V. Milev, P. Giacobbe, and S. H. Kennedy, Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 Clinical Guidelines for the Management of Adults with Major Depressive Disorder: Section 4. Neurostimulation Treatments, Canadian journal of psychiatry Revue canadienne de psychiatrie, vol.61, issue.9, pp.561-75, 2016.

J. Puthumana, J. D. Wallach, and J. S. Ross, Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy DesignationClinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy DesignationLetters, Jama, vol.320, issue.3, pp.301-304, 2018.

E. H. Turner, A. M. Matthews, E. Linardatos, R. A. Tell, and R. Rosenthal, Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy, New England Journal of Medicine, vol.358, issue.3, pp.252-60, 2008.