%0 Journal Article
%T International Study to Predict Optimized Treatment for Depression (iSPOT-D), a randomized clinical trial: rationale and protocol
%A Leanne M Williams
%A A Rush
%A Stephen H Koslow
%A Stephen R Wisniewski
%A Nicholas J Cooper
%A Charles B Nemeroff
%A Alan F Schatzberg
%A Evian Gordon
%J Trials
%D 2011
%I BioMed Central
%R 10.1186/1745-6215-12-4
%X 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) na£żve 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.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.International Study to Predict Optimised Treatment - in Depression (iSPOT-D) ClinicalTrials.gov Identifier: NCT00693849URL: http:/ / clinicaltrials.gov/ ct2/ show/ NCT00693849?term=International+Stud y+to+Predict+Optimized+Treatment+fo r+Depression&rank=1 webciteMajor depressive disorder (MDD) is the fourth most disabling medical condition worldwide (based on disability-adjusted lifeyears) and is expected to be ranked second by year 2020 [1,2]. MDD is typically recurrent, often chronic and disabling, with a lifetime prevalence rate of over 15% [3]. Women are approximately twice as likely to dev
%U http://www.trialsjournal.com/content/12/1/4