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

Trials. 2011 Jan 5;12:4. doi: 10.1186/1745-6215-12-4.

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

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antidepressive Agents, Second-Generation / adverse effects
  • Antidepressive Agents, Second-Generation / therapeutic use*
  • Australia
  • Citalopram / adverse effects
  • Citalopram / therapeutic use*
  • Cognition / drug effects
  • Cyclohexanols / adverse effects
  • Cyclohexanols / therapeutic use*
  • Decision Support Techniques
  • Depressive Disorder, Major / diagnosis
  • Depressive Disorder, Major / drug therapy*
  • Depressive Disorder, Major / psychology
  • Electroencephalography
  • Emotions / drug effects
  • Europe
  • Female
  • Humans
  • Male
  • Middle Aged
  • Neuropsychological Tests
  • New Zealand
  • Prospective Studies
  • Psychiatric Status Rating Scales
  • Quality of Life
  • Research Design*
  • Serotonin Uptake Inhibitors / adverse effects
  • Serotonin Uptake Inhibitors / therapeutic use*
  • Sertraline / adverse effects
  • Sertraline / therapeutic use*
  • Social Behavior
  • Time Factors
  • Treatment Outcome
  • United States
  • Venlafaxine Hydrochloride
  • Young Adult

Substances

  • Antidepressive Agents, Second-Generation
  • Cyclohexanols
  • Serotonin Uptake Inhibitors
  • Citalopram
  • Venlafaxine Hydrochloride
  • Sertraline

Associated data

  • ClinicalTrials.gov/NCT00693849