11:30am - 12:00pm
Track 4: Rudolf-Virchow Room
Treatment Resistant Depression (TRD): A Regulatory Perspective on Recent Therapeutic Developments
Treatment resistant depression is still a therapeutic area of substantial unmet medical need. The regulatory requirements for the development of medicinal products in difficult to treat patients with Major Depressive Disorder (MDD) will be outlined with a special focus on medicinal products with new mechanisms of action and/or rapid onset of effect. A recent example (intranasal esketamine) and implications on study designs will be discussed.