Anxiety and somatic symptoms as predictors of treatment-related adverse events in major depressive disorder.

The purpose of this study was to examine the relationship between the degree of anxiety or somatic symptoms present before treatment with the subsequent diagnosis of treatment-related adverse events (TRAEs) in patients with major depressive disorder (MDD) enrolled in an 8-week open trial of fluoxetine (20 mg). Baseline symptom questionnaires (SQ) were completed by 170 MDD patients enrolled in the trial. We then tested whether pre-treatment scores for anxiety and somatic symptoms predicted (1) whether patients were subsequently diagnosed with TRAEs; (2) whether they were subsequently diagnosed with moderate or severe TRAEs; or (3) whether a greater number of TRAEs were diagnosed during the trial. We found that depressed patients who presented with prominent somatic symptoms were significantly more likely to report at least one moderate or severe side effect during the course of treatment, but not more likely to report a greater number of side effects. Pre-treatment anxiety was not related to the development of side effects. Copyright 2004 Elsevier Ireland Ltd.