Background. Major Depressive Disorder represents a global burden disease with highly heterogenous clinical features. Approximately 30-50% of patients do not respond to first-line therapies, experimenting treatment-resistant depression (TRD). Recently Esketamine, an innovative and rapidly-acting agent, has been approved for the management of TRD. Esketamine efficacy has been widely investigated in several trials, but real-world studies are needed to validate RCT results in clinical practice. Besides, there is an urgent need to investigate potential markers able to predict treatment response to Methods. We design a protocol for a multicentric, retrospective, observational and real-world study to evaluate efficacy, safety and tolerability of Esketamine nasal spray treatment in a clinical and non-experimental sample of TRD patient, speculating on possible TRD subphenotypes with high response rates to Esketamine treatment. Anamnestic data and Psychometric assessment (MADRS, HAMD, BPRS, BDI) related to three different stages will be considered: baseline (T0), 1 month (T1) and three months (T2) from the treatment beginning. Discussion. This study will provide a real-world experience of Esketamine use in a clinical sample of TRD patients from several Italian Mental Health Services. Clinical settings will give a real-world sample, possibly characterized by several differences from the experimental sample of esketamine RCT (with probably higher rates of co-occurrent disorders, substance abuse, longer illness duration and more heterogenous therapies administered).Furthermore, we will couple psychometric assessments, anamnestic data and clinical response to Esketamine to identify possible clinical markers predictor of response. Identify TRD subphenotypes with high response rates to treatment may represent a relevant scientific development, considering the urgent need of “tailored” therapies to overcome resistance in TRD.
Esketamine in treatment resistant depression: a study protocol for a retrospective, real-life, multicentric study
Stefano Barlati;Antonio Vita;
2022-01-01
Abstract
Background. Major Depressive Disorder represents a global burden disease with highly heterogenous clinical features. Approximately 30-50% of patients do not respond to first-line therapies, experimenting treatment-resistant depression (TRD). Recently Esketamine, an innovative and rapidly-acting agent, has been approved for the management of TRD. Esketamine efficacy has been widely investigated in several trials, but real-world studies are needed to validate RCT results in clinical practice. Besides, there is an urgent need to investigate potential markers able to predict treatment response to Methods. We design a protocol for a multicentric, retrospective, observational and real-world study to evaluate efficacy, safety and tolerability of Esketamine nasal spray treatment in a clinical and non-experimental sample of TRD patient, speculating on possible TRD subphenotypes with high response rates to Esketamine treatment. Anamnestic data and Psychometric assessment (MADRS, HAMD, BPRS, BDI) related to three different stages will be considered: baseline (T0), 1 month (T1) and three months (T2) from the treatment beginning. Discussion. This study will provide a real-world experience of Esketamine use in a clinical sample of TRD patients from several Italian Mental Health Services. Clinical settings will give a real-world sample, possibly characterized by several differences from the experimental sample of esketamine RCT (with probably higher rates of co-occurrent disorders, substance abuse, longer illness duration and more heterogenous therapies administered).Furthermore, we will couple psychometric assessments, anamnestic data and clinical response to Esketamine to identify possible clinical markers predictor of response. Identify TRD subphenotypes with high response rates to treatment may represent a relevant scientific development, considering the urgent need of “tailored” therapies to overcome resistance in TRD.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
