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Background: Clinically useful treatment moderators of Major Depressive Disorder (MDD) have not yet been identified, though some baseline predictors of treatment outcome have been proposed. The aim of iSPOT-D is to identify pretreatment measures that predict or moderate MDD treatment response or remission to escitalopram, sertraline or venlafaxine; and develop a model that incorporates multiple predictors and moderators., Methods/design: The International Study to Predict Optimized Treatment - in Depression (iSPOT-D) is a multi-centre, international, randomized, prospective, open-label trial. It is enrolling 2016 MDD outpatients (ages 18-65) from primary or specialty care practices (672 per treatment arm; 672 age-, sex- and education-matched healthy controls). Study-eligible patients are antidepressant medication (ADM) naïve or willing to undergo a one-week wash-out of any non-protocol ADM, and cannot have had an inadequate response to protocol ADM. Baseline assessments include symptoms; distress; daily function; cognitive performance; electroencephalogram and event-related potentials; heart rate and genetic measures. A subset of these baseline assessments are repeated after eight weeks of treatment. Outcomes include the 17-item Hamilton Rating Scale for Depression (primary) and self-reported depressive symptoms, social functioning, quality of life, emotional regulation, and side-effect burden (secondary). Participants may then enter a naturalistic telephone follow-up at weeks 12, 16, 24 and 52. The first half of the sample will be used to identify potential predictors and moderators, and the second half to replicate and confirm., Discussion: First enrolment was in December 2008, and is ongoing. iSPOT-D evaluates clinical and biological predictors of treatment response in the largest known sample of MDD collected worldwide., Trial Registration: International Study to Predict Optimised Treatment - in Depression (iSPOT-D) ClinicalTrials.gov Identifier: NCT00693849. URL: http://clinicaltrials.gov/ct2/show/NCT00693849?term=International+Study+to+Predict+Optimized+Treatment+for+Depression&rank=1

Early life stress (ELS) has been linked to adult psychopathology, though few studies have examined the universality of specific adverse childhood events (ACEs) in healthy adults. We examined the co-occurrence of specific ACEs and their relationship to current emotional distress in an international sample of adults without psychopathology. Participants were 1659 men and women recruited for an international neurocognitive-neuroimaging database from sites in the United States, Australia, England, and the Netherlands. Participants had no current or prior diagnosis of major depression, anxiety, substance abuse, or neurological brain disorder. The occurrence and age on onset of 19 ACEs was assessed by a self-report questionnaire (ELSQ), and current symptoms of stress, depression, and anxiety by the Depression Anxiety Stress Scale (DASS). The relationship of specific ACEs to DASS symptoms was examined. Participants reported relatively high prevalence of ACEs. Only 27.6% of the sample reported no ACEs, while 39.5% reported one or two significant experiences and 32.9% reported more than two ACEs. Rates of most ACEs were quite similar across the three continents. Various ACEs were significantly associated with current DASS severity, particularly ACEs involving emotional abuse, neglect, and family conflict, violence, and breakup. Finding nearly one-third of the sample reported three or more ACEs suggest a high prevalence of ELS in otherwise healthy "normal" adults around the world. Associations between ELS and current emotional distress suggest that these events have functional relevance and deserve further investigation.