Unit:
Κατεύθυνση Κλινικές Μελέτες: Σχεδιασμός και ΕκτέλεσηLibrary of the School of Health Sciences
Supervisors info:
Καστρίτης Ευστάθιος, Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Μίγκου Μαγδαληνή, Εξωτερική Συνεργάτης, Ιατρική Σχολή, ΕΚΠΑ
Ιστίκογλου Χρήστος, Εξωτερικός Συνεργάτης, Ιατρική Σχολή, ΕΚΠΑ
Original Title:
Βιβλιογραφική ανασκόπηση στις κλινικές μελέτες για τα αντικαταθλιπτικά: δευτερεύοντα καταληκτικά σημεία και στατιστική σημαντικότητα τους
Translated title:
Literature review of clinical trials in antidepressants: secondary endpoints and statistical significance
Summary:
Major Depressive Disorder (MDD) is one of the most common psychiatric disorders. It is considered chronic, recurrent and multifactorial. It is associated with multiple and different genetic, biological and psychosocial factors that interact in several ways.
The mechanism of action of antidepressant drugs are complex but the general principle is the same.
Patients suffering from MDD who receive therapy will improve. To date, the ultimate purpose of antidepressant therapy is the complete remission, the maintenance of remission for a long time and the avoidance of recurrence.
An explosion of potential therapeutic choices using innovative designs are being investigated in MDD using multiple protocols. Having so many choices, deciding on the best drug is often difficult.
FDA and EMA in USA and Europe are responsible for the development, the conduction and the documentation of the safety and the efficacy of the new drugs upon their approval marketing.
Developing medicinal products to treat depression come across certain concerns. In mental health disorders design and conduction of clinical trials are challenging. The right choice, the hierarchy and the analysis of endpoints are extremely important and complicated.
The purpose of this dissertation is to review the basic principles in clinical trials in antidepressants focusing on clinical endpoints and to highlight the existing gap and the need for improvement in order to develop and update the existing endpoints but also to develop and register new, more sensitive endpoints that will have sufficient power to help in the approval of new medication to treat this multidimensional disorder.
Main subject category:
Health Sciences
Keywords:
Depression, Clinical trials, Endpoints, Statistical analysis
File:
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Kentroti_Dimitra_MSc.pdf
2 MB
File access is restricted only to the intranet of UoA.
