Treatment-Resistant Depression in Colombia: Results From a Longitudinal Analysis of the TRAL Study

This manuscript reports on the clinical outcomes (response, remission and relapse) in TRD patients in Colombia under Standard-of-Care (SOC), and patient reported outcomes (PROs) - QoL, disability, depression severity - over a 1-year follow-up.

From a sample of 162 MDD patients from 4 centres in Colombia, 52 had a formal diagnosis of TRD and were included in the 1-year follow-up. Exclusion criteria were patients with psychosis, schizophrenia, bipolar disorder, schizoaffective disorder, dementia, with severe chemical dependence or currently participating in another clinical trial. Clinical outcomes were measured with MADRS and PHQ-9, while PROs included EQ-5D (QoL) and Sheehan Disability Scale (SDS - disability).

Patients' mean age was 41.88 years, 80.8% of which were female, 37.3% were married or on consensual union and 42.3% had at least 13 years of formal education. Half of the sample achieved clinical response after 1-year of follow-up, while remission was not achieved by 57.9% of the participants (MADRS). Over 60% of the patients had mild to severe depression at the end of study (PHQ-9), while 57.9% reported feeling anxious/depressed (EQ-5D). Over three-quarters of the sample reported disruption in work/school, social life/leisure and family/home responsibilities (SDS).

Present results for Colombia underline the burden of TRD in most aspects of daily living. Current SOC fails to deliver the necessary clinical outcomes and patient centric approach, which suggests the need to improve treatment protocols, while increasing access to specialists, foster earlier diagnosis and the implementation on a nationwide programme for mental health.