Abstract

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 < 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.

Highlights

  • Major depressive disorder (MDD), which affects >300 million individuals worldwide, can severely impact functionality and quality of life (QoL) and may even be fatal [1, 2]

  • Results from the EQ-5D-5L health-related quality of life (HRQoL) questionnaire demonstrated that treatment-resistant depression (TRD) patients in comparison to non-TRD patients were significantly more impacted on the mobility, self-care, usual activities, pain/discomfort, anxiety/depression, and current health subscales

  • Depression severity scores on the Patient Health Questionnaire-9 (PHQ-9) were higher in TRD patients (P < 0.0001), with 40.2% of TRD patients characterized as having severe depression

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Summary

Introduction

Major depressive disorder (MDD), which affects >300 million individuals worldwide, can severely impact functionality and quality of life (QoL) and may even be fatal [1, 2]. Increases in depression severity are associated with an increased risk of suicidal ideation and suicide attempts [10, 11]. In one study, those with severe depression were 20 times more likely than those with no or mild depression to report suicidal ideation [10]. Those with severe depression were 20 times more likely than those with no or mild depression to report suicidal ideation [10] In another study, those with the most severe depression symptoms had an 8-fold increased risk of a suicide attempt [11]. Suicidal ideation and behavior can present significant treatment challenges, and identification of risk factors for suicide, including depression severity, is an important aspect of appropriate management of MDD patients [12]. 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

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