Background: We report on two multi-center, prospective, observational studies (H6U-BC-LRAG and H6U-BL-LRAH) to determine the clinical profile of Latin American outpatients with major depressive disorder (MDD) and the relationship between depression severity, painful somatic symptoms, and quality of life.

Method: Patients (n = 989) with MDD were classified according to the presence (SS+) or absence (SS-) of painful somatic symptoms using the Somatic Symptom Inventory (SSI). Visual Analogue Scale (VAS) quantified pain severity, HAMD17 and CGI-S determined depression severity, while the Quality of Life in Depression Scale (QLDS) quantified subjective well-being.

Results: At baseline, patients had an average CGI score of 4.5 (+/- 0.8) and HAMD17 score of 24.9 (+/- 7.2). Of the patients studied, 72.6% reported painful somatic symptoms (95% CI: 69.8, 75.4), with women 2.7 times more likely to be SS+ than men (p < 0.0001). Adjusted mean HAMD17 (26.79) and CGI-S (4.53) scores for SS+ patients were significantly (p < 0.0001) higher than for SS- patients (HAMD(17): 22.87; CGI-S: 4.28). SS+ patients had greater severity of pain across all VAS measures (p < 0.0001). The presence of somatic symptoms had a significantly deleterious effect on quality of life (p < 0.0001).

Conclusion: Greater severity of painful somatic symptoms was associated with increased depression severity and reduced quality of life. We concluded that both emotional and physical manifestations of MDD must be addressed for successful treatment.

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