Abstract
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.
Highlights
Major depressive disorder (MDD) is a worldwide health concern, affecting over 300 million people
Patients were from 33 centers in four countries: Mexico (n = 697; 47% of all patients), Colombia (n = 162; 11%), Brazil (n = 396; 27%), and Argentina (n = 220; 15%)
The lowest prevalence of treatment-resistant depression (TRD) was observed in Mexico (21%) and the highest was observed
Summary
Major depressive disorder (MDD) is a worldwide health concern, affecting over 300 million people. The impact of MDD on disability is due, in part, to a substantial proportion of patients with MDD who do not respond to current treatments despite available antidepressants and augmentation strategies [4]. An estimated one-third of patients with MDD have treatment-resistant depression (TRD), usually defined as a failure to respond to ≥ 2 antidepressant medications of adequate dose and duration [5,6,7]. Compared to patients with MDD who are not resistant to treatment, those with TRD have more comorbidities, poorer health-related quality of life, greater risk of suicide, greater direct and indirect healthcare resource utilization, and greater costs [8,9,10,11,12,13,14]. In the United States, only fluoxetine/olanzapine was approved for the treatment of TRD until March 2019, when intranasal esketamine was approved [15,16,17]
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