Journal Article

International Study to Predict Optimized Treatment for Depression (iSPOT-D), a randomized clinical trial: rationale and protocol

Wisniewski, Stephen R, Williams, Leanne M, Cooper, Nicholas J, Rush, A John, Schatzberg, Alan F, Gordon, Evian, Nemeroff, Charles B, Koslow, Stephen H

2011

Overview

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

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adolescent / Adult / Aged / Antidepressive Agents, Second-Generation - adverse effects / Antidepressive Agents, Second-Generation - therapeutic use / Australia / Biomedicine / Brain research / Care and treatment / Citalopram - adverse effects / Citalopram - therapeutic use / Clinical medicine / Clinical trials / Cognition - drug effects / Cyclohexanols - adverse effects / Cyclohexanols - therapeutic use / Data collection / Decision Support Techniques / Depressive Disorder, Major - diagnosis / Depressive Disorder, Major - drug therapy / Depressive Disorder, Major - psychology / Electroencephalography / Emotions - drug effects / Europe / Female / Health Sciences / Humans / Magnetic resonance imaging / Major depressive disorder / Male / Medicine / Medicine & Public Health / Mental depression / Mental disorders / Middle Aged / Neuropsychological Tests / New Zealand / Outcome and process assessment (Health Care) / Patient outcomes / Prospective Studies / Psychiatric Status Rating Scales / Quality of Life / Questionnaires / Remission (Medicine) / Research Design / Serotonin Uptake Inhibitors - adverse effects / Serotonin Uptake Inhibitors - therapeutic use / Sertraline - adverse effects / Sertraline - therapeutic use / Social Behavior / Statistics for Life Sciences / Study Protocol / Time Factors / Treatment Outcome / United States / Venlafaxine Hydrochloride / Young Adult