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

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

Research output: Contribution to journalArticle

104 Scopus citations

Abstract

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.

Original languageEnglish (US)
Article number4
JournalTrials
Volume12
DOIs
StatePublished - Jan 5 2011

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

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    Williams, L. M., Rush, A. J., Koslow, S. H., Wisniewski, S. R., Cooper, N. J., Nemeroff, C. B., Schatzberg, A. F., & Gordon, E. (2011). International Study to Predict Optimized Treatment for Depression (iSPOT-D), a randomized clinical trial: Rationale and protocol. Trials, 12, [4]. https://doi.org/10.1186/1745-6215-12-4