Short-term preliminary clinical & functional results by TRD stage from HIPOCRAT-ESK study: a cohort, non-interventional, prospective, real-world study of functional remission in TRD patients treated with Esketamina nasal spray
T. Caraballo Lopez, M. García Dorado, N. Cardoner Álvarez, Á. Ibáñez Cuadrado, S. Benavente López, P. Alonso OrtegaIntroduction
Treatment-resistant depression (TRD) patients experience a higher burden of illness and worse clinical prognosis. The potential for functional improvement decreases with symptom chronicity and treatment failure.
Objectives
To report the initial functional results of HIPOCRAT-ESK aims to assess functional remission rates in TRD patients under ESK NS treatment at different TRD stages, evaluating if early intervention relates to more beneficial functional and clinical outcomes in Spanish clinical practice.
Methods
HIPOCRAT-ESK is a cohort, non-interventional, prospective, real-world study evaluating functions remission as a primary endpoint in TRD patients treated with ESK NS as per the Spanish clinical practice. It aims to include a total sample of 300 TRD patients and complete a prospective follow-up of 12 months. The study will explore the impact of TRD stage (TRD4, TRD5 or TRD6+, depending on the number of prior failed antidepressants) upon functional and clinical response and remission rates. We present the short-term clinical and functional results by TRD stage.
Results
Clinical evolution results show that an earlier use of ESK NS correlates with higher MADRS response and remission rates (Table 1). Functional remission rates also were higher in those patients with a lesser number of prior failed antidepressant therapies (TRD4 and TRD% cohorts) in comparison with more chronic patients (TRD6+ cohort) (Table 2). PROs (PHQ-9 and EQ-5D-5L) results also pointed to a more beneficial clinical and impact perception from the patients when ESK NS was introduced as earlier treatment lines. In the case of PHQ-9 is especially relevant the amelioration of Pain/discomfort and anxiety/depression items in patients in the earlier cohorts (TRD4).
MADRS score evolution by TRD Stage Table 1. Long description.