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

Leanne M Williams12*, A John Rush3, Stephen H Koslow14, Stephen R Wisniewski5, Nicholas J Cooper6, Charles B Nemeroff7, Alan F Schatzberg8 and Evian Gordon26

Author Affiliations

1 BRAINnet Foundation, 71 Stephenson Street, Suite 400, San Francisco, CA, 94105, USA

2 Westmead Millennium Institute, University of Sydney Medical School, Westmead Hospital, NSW 2145, Australia

3 Duke-NUS Graduate Medical School Singapore, 8 College Road, 169857, Singapore

4 American Foundation for Suicide Prevention, 120 Wall Street, 22nd Floor New York, NY 10005, USA

5 Department of Epidemiology, University of Pittsburgh, 127 Parran Hall, Pittsburgh, PA 15261, USA

6 Brain Resource International Database, Brain Resource Ltd, Sydney, Australia and San Francisco, USA

7 Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami FL 33136, USA

8 Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA 94305, USA

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Trials 2011, 12:4  doi:10.1186/1745-6215-12-4

Published: 5 January 2011

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 webcite