Treatment-Resistant Depression in America Latina study: one-year follow-up of treatment resistant depression patients under standard of care reveals insights on quality of life, disability, work impairment, and depressive symptoms.

Introduction: Depressive Disorders are on the rise worldwide. This is also the case in Latin America (LatAm). Treatment-Resistant Depressive Disorder (TRD) poses additional burden to patients with depression. Impacts quality of life (QoL) and other dimensions, and standard of care (SOC) is insufficient to achieve the desired clinical outcomes. Evidence from LatAm is, however, lacking. The present study was devised as a 1-year follow-up of the SOC in TRD patients in LatAm to explore the burden of TRD. Methods: This was an observational, multinational, longitudinal study. Patients with clinical diagnosis of TRD in LatAm were included in a 1-year follow-up with SOC. Beyond the Sociodemographic characterization, outcome measures were QoL (EQ-5D-5L), disability (Sheehan Disability Scale - SDS), work productivity (Work Productivity and Activity Incapacity Questionnaire: depression - WPAI:D) and depression severity (Patient Health Questionnaire-PHQ9). Patients were assessed every 3-months and comparison was performed based on change from baseline to each visit and end of study (EOS - 12 months). Results: Patients averaged 48 (± 13.12) years, mostly female (80.9%) and married/consensual union (42.5%) or single patients (34.4%). Despite the SOC treatment, three-quarters of the patients remained symptomatic at EOS, regardless of the significant longitudinal decrease (p ≤ 0.001). Similar trends were found for disability (p ≤ 0.001) -82.2% of the patients reporting work/school disruption at EOS-, percentage of work (34%) and activity impairment (40%) at EOS (p ≤ 0.001) and only 29.2% of patients with depressive severity "none" at EOS (p ≤ 0.001). The results portray the need to improve clinical outcomes in this complex and burdensome disease in LatAm. Discussion: Here we show that the burden of TRD remains significant in essential dimensions of everyday life at EOS underlining the need for better therapeutic solutions. The improvements in most patients do not provide the desired outcome of return to the state before the condition. Further research should focus on identifying which treatments provide better outcomes in a real-world context.

Treatment-Resistant Depression in Argentina: results from a longitudinal analysis of the TRAL Study / Depresión resistente al tratamiento en Argentina: resultados de un análisis longitudinal del estudio TRAL.

Literature concerning patients with Treatment-Resistant Depression (TRD) treatment response and patient report outcomes (PROs) -such as QoL or disability- in Argentina is scarce. In the scope of the Treatment-Resistant Depression in America Latina (TRAL) study which previous results highlighted the burden of TRD compared to non-TRD patients as well as essential epidemiological data in the region, this paper reports on the outcomes of Standard-of-Care (SOC) over a 1-year follow-up of TRD patients in the subsample for Argentina. From a sample of 220 MDD patients identified in 5 sites in Argentina, 72 patients were diagnosed with TRD. Exclusion criteria included patients with psychosis, schizophrenia, bipolar disorder, schizoaffective disorder, dementia, with severe chemical dependence or currently participating in another clinical trial. MADRS, PHQ-9 and PROs (EQ-5D and SDS) were used as outcomes. Patients' mean age was 54.7 years and 70.3% of the patients were female. Around 61% of the patients achieved a response (reduction of MADRS score ≥ 50%), but over 33% did not achieve a remission (MADRS total score ≤12). Almost 67% of the patients still felt anxious/depressed at the end of the study (EQ-5D), while disruption affected patients in diverse areas -71% in work/school, 69.7% in social life/leisure and 66.6% in their family life/personal responsibilities. The burden of TRD is significant in Argentina, and more effort should be put in the implementation of treatment protocols with better outcomes.

La literatura disponible en relación a la respuesta al tratamiento de los pacientes con Depresión Resistente al Tratamiento (TRD) y los resultados del informe del paciente (PRO) -como la calidad de vida o la discapacidad- es escasa en Argentina. A partir de la submuestra de Argentina del estudio de depresión resistente al tratamiento en América Latina (TRAL), cuyos resultados anteriores destacaron la carga de TRD en comparación con los pacientes sin DRT, así como datos epidemiológicos esenciales en la región, este documento informa sobre los resultados del estándar de atención (Standard-of-Care, SOC) durante un seguimiento de 1 año de pacientes con DRT De una muestra de 220 pacientes con TDM de 5 centros de Argentina, 72 pacientes fueron diagnosticados con DRT. El criterio de exclusión excluyó a los pacientes con psicosis, esquizofrenia, trastorno bipolar, trastorno esquizoafectivo, demencia, dependencia química grave o que estaban participando en otro ensayo clínico. La MADRS, el PHQ-9 y los PRO (EQ-5D y SDS) se utilizaron como resultados. La edad media de los pacientes fue de 54,7 años y el 70,3 % de los pacientes eran mujeres. Alrededor del 61 % de los pacientes lograron una respuesta (reducción del ≥50 % en el puntaje total de MADRS), pero más del 33 %  no logró una remisión (puntuación total MADRS ≤12). Casi el 67 % de los pacientes seguían sintiéndose ansiosos/ deprimidos al final del estudio (EQ-5D), mientras que dicho trastorno afectó a los pacientes en diversas áreas: el 71 % en el trabajo/la escuela, el 69,7 % en la vida social/el tiempo libre y el 66,6 % en su vida familiar/las responsabilidades personales. La carga de la DRT es significativa en Argentina, y se debe hacer más esfuerzo en la implementación de protocolos de tratamiento con mejores resultados.

Gravidade da depressão, resposta ao tratamento e PRO (incapacidade e QoL) em pacientes com DRT em um ano de acompanhamento com tratamento padrão: análise do subgrupo brasileiro do estudo observacional multinacional TRAL / Depression severity, treatment response and PRO (disability and QoL) in TRD patients over a 1-year follow-up with standard of care: Analysis of the Brazilian subset of the multicenter, observational TRAL study

Objetivo: A depressão resistente ao tratamento (DRT) é uma preocupação primária no Brasil devido à sua natureza onerosa e complexa, enquanto o diagnóstico e o tratamento geralmente são desafiadores. O presente manuscrito apresenta os resultados clínicos de um ano de acompanhamento em pacientes com DRT em tratamento padrão (SOC) no subgrupo brasileiro do estudo de Depressão Resistente ao Tratamento na América Latina (TRAL). Métodos: Essa fase longitudinal do estudo TRAL tinha como meta caracterizar alterações nos resultados clínicos e outras variáveis de interesse (p. ex., qualidade de vida, incapacidade) em um ano de acompanhamento em pacientes com DRT em 10 centros no Brasil. Os pacientes incluídos tinham diagnóstico clínico de DRT com base nos critérios DSM-5 e confirmado por MINI. A Escala de Depressão de Montgomery-Asberg (MADRS) era usada para avaliar a gravidade da doença e os resultados clínicos. Outras escalas de depressão e instrumentos classificados pelo paciente eram usadas para medir resultados correlacionados. Resultados: Cento e cinquenta e oito pacientes com DRT, na maioria mulheres (84,4%) com idade média de 48,55 anos, foram incluídos na análise. Apenas 31,4% dos pacientes apresentaram uma resposta clinicamente significativa, 10,3% tiveram recidiva e 26,7% alcançaram remissão, conforme medido pela MADRS no final do estudo (EOS). Aproximadamente 55% dos pacientes apresentavam depressão grave/moderadamente grave no EOS. Problemas de mobilidade, cuidados pessoais, problemas nas atividades usuais e dor e desconforto foram relatados pela maioria dos pacientes no EOS, assim como comprometimento marcado/extremo das atividades no trabalho/escola e da vida social/das atividades de lazer no EOS. Conclusões: Os resultados clínicos alcançados atualmente ainda são notavelmente insatisfatórios para DRT. Portanto, o envolvimento de todas as partes interessadas é essencial para implementar protocolos de tratamento mais eficazes no Brasil.

Objective: Treatment-resistant depression (TRD) is a primary concern in Brazil due to its burdensome and complex nature, while diagnosis and treatment is often challenging. The current manuscript presents the clinical outcomes in a one-year follow-up of TRD patients under Standard-of-care (SOC) in the Brazilian subset of the Treatment-Resistant Depression in America Latina (TRAL) study. Methods: This longitudinal phase of TRAL aimed to characterize changes in the clinical outcomes and other variables of interest (e.g. quality of life, disability) in a one-year follow-up of TRD patients in 10 centers in Brazil. Included patients were clinically diagnosed with TRD based on DSM-5 criteria and confirmed by MINI. Montgomery-Asberg Depression Rating Scale (MADRS) was used to assess disease severity and clinical outcomes. Other depression scales and patient rated instruments were used to measure correlated outcomes. Results: One hundred fifty-eight TRD patients, mostly female (84.4%), averaging 48.55 years, were included in the analysis. Only 31.4% of the patients showed a clinically significant response, 10.3% had a relapse and 26.7% achieved remission, as measured through MADRS at end-of-study (EOS). Almost 55% of the patients showed moderately severe/severe depression at EOS. Mobility issues, self-care, problems with usual activities and pain and discomfort were reported by the majority of the patients at EOS, as well as marked/extreme disruption of school/work and social life/leisure activities at EOS. Conclusions: Currently achieved clinical outcomes are still remarkably unsatisfactory for TRD. Therefore, the involvement of all relevant stakeholders is essential to implement more effective treatment protocols in Brazil.

The management of adult psychiatric emergencies in low-income and middle-income countries: a systematic review.

The aim of this Review is to identify effective interventions and treatment guidelines to manage common types of psychiatric emergencies in non-specialist settings in low-income and middle-income countries. Mental health specialist services in low-income and middle-income countries are scarce. We did a systematic review of interventions for psychiatric emergencies and a literature search for low-income and middle-income-specific treatment guidelines for psychiatric emergencies. A dearth of high-quality guidelines and contextualised primary evidence for management of psychiatric emergencies in low-income and middle-income countries exists. Filling these gaps in present guidelines needs to be an urgent research priority in view of the adverse health and social consequences of such presentations and the present drive to scale up mental health care.