Short-term preliminary PROs results 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, J. Vendrell Serres, R. Gómez-JuanesIntroduction
Treatment-resistant depression (TRD), defined as failure to achieve remission after two or more antidepressant treatments, affects an estimated 55% of individuals with major depression disorder (MDD). TRD patients experience a higher burden of illness, including diminished cognitive functioning, decreased workplace performance, increased suicide risk, and higher likelihood of developing comorbidities. Furthermore, TRD is associated with an elevated socioeconomic burden due to increased healthcare resource utilization (HRU) and the need for more intensive treatments.
Objectives
To report the initial PROs results of HIPOCRAT-ESK, the first real-world, prospective study evaluating functional remission of TRD patients treated with ESK NS based 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 including 300 TRD patients with a prospective 12-months follow up where the patient’s perspective about clinial and quaility of life impact is colleted with PHQ-9 and EQ-5D-5L questionnaires. We present the short-term results of these two PROs over the first months of treatment of the first 25% of total sample recruited.
Results
83 patients were included in the ITT analysis. Baseline characteristics show a severely impacted (both at clinical and QoL level) sample as noted by the basal mean PHQ-9 score (20.64) and EQ-5D-5L (36.45). Despite the worsened prognosis of TRD population, patients treated with ESK NS as per clinicla practice, reported positive evolution soon after treatment initiation. The percentage of patients auto-classified as severely depressed in the beginning decreased from 63.83% to 32.86% by day 28 (end of ESK NS induction; Table 1). In parallel, no/minimal depressed and mildly depressed categories increased from 0% to 4.29% and from 1.20% up to 14.29%, respectively. QoL results (reported by EQ-5D-5L), showed a marked positive impact in QoL after ESK NS treatment initiation, with increasing number of patients reporting no problems/slight problems in every of the 5 questionnaire’s dimension during the induction phase.
PHQ-9 total score evolution Table 1. Long description.