A year of standard of care (SOC) therapy for treatment resistant depression (TRD) had suboptimal effects on symptoms of depression and suicidality. These findings were published in the the Revista de Psiquiatría y Salud Mental (Journal of Psychiatry and Mental Health).

The Treatment-resistant Depression in America Latina (TRAL) study was conducted at centers in Argentina, Brazil, Colombia, and Mexico between 2017 and 2018. In this analysis, outcomes of SOC for TRD were evaluated at 1 year. Symptoms of depression were assessed with the Montgomery-Åsberg Depression Rating Scale (MADRS) and suicidality by the Columbia-Suicide Severity Rating Scale (C-SSRS) every 3 months during the follow-up period.

The study cohort comprised 430 patients, aged mean 48.49 (range, 18.00-83.00) years, 80.9% were women, they were diagnosed with major depressive disorder (MDD) at 37.29 (range, 5.00-77.00) years of age, 9.8% were hospitalized for MDD in the previous year, and the average length of hospital stay was 54.19 (range, 1.00-430.00) days.


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Compared with baseline, fewer patients endorsed empty feelings (98.6% vs 65.2%), pessimism (90.7% vs 56.2%), guilt (83.0% vs 52.9%), irritability (81.5% vs 49.2%), loss of interest (95.6% vs 55.8%) fatigue (96.7% vs 66.1%), difficulty concentrating (92.1% vs 60.9%), sleep problems (83.0% vs 42.4%), abnormal eating (75.3% vs 39.1%), suicidal ideation (38.6% vs 14.2%), and persistent pain (56.7% vs 43.8%) at the 1-year follow-up.

At 1 year, the average MADRS score had decreased from 29.34 to 17.47 (β, -0.951; P <.0001). The proportion of patients who had treatment response, as defined by a ≥50% reduction in MADRS score, was 18.8% at visit 2, 24.1% at visit 3, 34.3% at visit 4, and 44.1% at the final follow-up. The proportion of patients in remission, as defined by a MADRS score ≤12, was 18.5% at visit 2, 22.1% at visit 3, 32.2% at visit 4, and 40.2% at the final follow-up.

The average suicidal ideation score decreased from 3.93 at baseline to 0.56 at the 1-year follow-up. The proportion of patients who had active suicidal ideation with specific plans was lowest at the third visit (10.6%), increasing at the fourth (21.3%) and final (28.3%) visits.

This study was limited by the heterogeneity of treatment protocols across study sites.

The study authors concluded, “SOC offers some relevant clinical benefits but fails to deliver on the overall unmet need in the treatment of TRD patients in Latin America. The persistence of symptoms observed among TRD patients after 1 year under SOC underlines the burden of the disease. Beyond the most common and manageable symptoms of depression, current treatment protocols fail to deliver on the management of this life-threatening condition as suicidality is not fully addressed and remains significant over time.”

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

Reference

Caldieraro MA, Teng CT, Baena LMA, et al. Depression and suicidality severity among TRD patients after 1-year under standard of care: Findings from the TRAL study, a multicenter, multinational, observational study in Latin America. Rev Psiquiatr Salud Ment. Published online June 26, 2022. doi:10.1016/j.rpsm.2022.06.002