Approximately one-third of patients with major depressive disorder (MDD) have treatment-resistant depression (TRD). The TRAL study will evaluate the prevalence and impact of TRD among patients with MDD in four Latin American countries. In this multicenter, prospective, observational study, patients with MDD were recruited from 33 reference sites in Mexico, Colombia, Brazil, and Argentina. Patients were assessed for TRD, defined as failure to respond to ≥ 2 antidepressant medications of adequate dose and duration. Demographics, previous/current treatments, depressive symptoms, functioning, healthcare resource utilization, and work impairment were also collected and evaluated using descriptive statistics, chi-square test, Fisher exact test, t-test for independent samples, or the Mann–Whitney nonparametric test, as appropriate. 1475 patients with MDD were included in the analysis (mean age, 45.6 years; 78% women); 89% were receiving relevant psychiatric treatment. 429 patients met criteria for TRD, and a numerically higher proportion of patients with TRD was present in public versus private sites of care (31% vs 27%). The mean Montgomery-Asberg Depression Rating Scale score was 25.0 among all MDD patients and was significantly higher for patients with TRD versus non-TRD (29.4 vs 23.3; P < 0.0001). Patients with TRD, versus those with non-TRD, were significantly more likely to be older, have a longer disease duration, have more comorbidities, be symptomatic, have a higher median number of psychiatric consultations, and report greater work impairment. Patients with TRD have a disproportionate burden of disease compared to those with non-TRD. Appropriate treatment for TRD is a substantial unmet need in Latin America. https://www.ClinicalTrials.gov identifier NCT03207282, 07/02/2017.

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BackgroundA large proportion of patients with major depressive disorder (MDD) have treatment-resistant depression (TRD). The TRAL study examines the impact of TRD on suicidality and health-related quality of life (HRQoL) among MDD patients in 4 Latin American countries.MethodsIn this multicenter, prospective, observational study, MDD patients were recruited from 33 sites in Mexico, Colombia, Brazil, and Argentina. Patients were assessed for TRD, defined as failure to respond to ≥2 antidepressant medications of adequate dose and duration. Other assessments included current disease status, Mini International Neuropsychiatric Interview (MINI), Columbia-Suicide Severity Rating Scale (C-SSRS), 5 Level EQ-5D (EQ-5D-5L), Patient Health Questionnaire-9 (PHQ-9), and Sheehan Disability Scale (SDS).Results1,475 MDD patients were included in the analysis (mean age, 45.6 years; 78% women), and 429 met criteria for TRD. Thoughts of suicide and suicide attempts were more common among TRD patients (38.7%) compared with non-TRD patients (24.9%; P &lt; 0.0001), according to the current disease status questionnaire. The C-SSRS showed that lifetime suicidal behavior was significantly more common among TRD patients than non-TRD patients (13.8 vs. 10.0%; P = 0.0384). Compared with non-TRD patients, TRD patients showed significantly greater adverse impacts on QoL (EQ-5D-5L), more severe depression (PHQ-9), and greater functional impairment (SDS).ConclusionTRD patients in clinical sites from Mexico, Colombia, Brazil, and Argentina were more likely to experience suicidality and negative effects on HRQoL than non-TRD patients.

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La prevalencia de la Depresión Resistente al Tratamiento (DRT) varía considerablemente entre regiones, y la Argentina carece de una epidemiología de la DRT. En función del estudio de Depresión resistente al tratamiento en América Latina (Treatment-Resistant Depression in Latin America, TRAL), en este documento se informa la epidemiología y la carga de la DRT en pacientes con trastorno depresivo mayor (TDM) en Argentina. Se incluyó una muestra de pacientes adultos con diagnóstico clínico de TDM (n = 396) de 5 centros en Argentina. Se excluyó a los pacientes con psicosis, esquizofrenia, trastorno bipolar, trastorno esquizoafectivo, demencia, dependencia química grave o que estaban participando en otro ensayo clínico. Los resultados informados por el paciente y las escalas de evaluación clínica se usaron como resultados. La prevalencia de la DRT en pacientes con TDM en Argentina es del 33,2%, basado en datos TRAL. Los pacientes con DRT son mayores en comparación con los pacientes sin DRT y es más evidente en pacientes con TDM que están casados o tienen una unión consensuada. En pacientes con DRT, se identificó una mayor tendencia suicida, mayor comorbilidad en MINI, los peores resultados en la escala MADRS y el cuestionario PHQ-9. La prevalencia identificada en el estudio TRAL para Argentina es  sustancial en comparación con otros países de Latinoamérica y con la prevalencia mundial. La DRT representa una carga desproporcionada para la sociedad. Se requieren esfuerzospara reducir la carga del TDM y la DRT en Argentina; para ello es necesario mejorar el diagnóstico temprano y el tratamiento terapéutico y garantizar que todos los pacientes tengan un mejor acceso a la atención de salud mental .