title: International Study to Predict Optimized Treatment for Depression (iSPOT-D), a randomized clinical trial: rationale and protocol.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  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
authors.affiliation: BRAINnet Foundation, 71 Stephenson Street, Suite 400, San Francisco, CA, 94105, USA. lea.williams@brainnet.net
authors.forename: Leanne M
authors.initials: LM
authors.lastname: Williams
authors.forename: A John
authors.initials: AJ
authors.lastname: Rush
authors.forename: Stephen H
authors.initials: SH
authors.lastname: Koslow
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Wisniewski
authors.forename: Nicholas J
authors.initials: NJ
authors.lastname: Cooper
authors.forename: Charles B
authors.initials: CB
authors.lastname: Nemeroff
authors.forename: Alan F
authors.initials: AF
authors.lastname: Schatzberg
authors.forename: Evian
authors.initials: E
authors.lastname: Gordon
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018687:Antidepressive Agents, Second-Generation / Q000009:adverse effects / Q000627:therapeutic use*; D001315:Australia; D015283:Citalopram / Q000009:adverse effects / Q000627:therapeutic use*; D003071:Cognition / Q000187:drug effects; D003511:Cyclohexanols / Q000009:adverse effects / Q000627:therapeutic use*; D003661:Decision Support Techniques; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D004569:Electroencephalography; D004644:Emotions / Q000187:drug effects; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D009520:New Zealand; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D012107:Research Design; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D020280:Sertraline / Q000009:adverse effects / Q000627:therapeutic use*; D012919:Social Behavior; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D000069470:Venlafaxine Hydrochloride; D055815:Young Adult
chemical_list: D018687:Antidepressive Agents, Second-Generation; D015283:Citalopram; D003511:Cyclohexanols; D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline; D000069470:Venlafaxine Hydrochloride