Evidence map›Paper›PMID 21208417›Full record

Trial reportTrials2011

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

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

2 registry-linked trialsOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 86 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
86citing papers in PubMed, 1 pooled it
8.4field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00693849 phase4unknown statusnot on this map

International Study to Predict Optimised Treatment - in Depression

TypeinterventionalSponsorBRC Operations Pty. Ltd.Ran2008 to 2019Enrolled2,688ConditionsMajor Depressive DisorderArmsEscitalopram, Sertraline, Venlafaxine-XR
NCT01635218 phase2completednot on this mapstarted 2012, after this paper: background citation

Efficacy of Individualized Homeopathic Treatment for Moderate to Severe Depression in Peri- and Postmenopausal Women: a Randomized Placebo-controlled, Double-blind, Double-dummy, Study Protocol

TypeinterventionalSponsorHospital Juarez de MexicoRan2012 to 2014Enrolled133ConditionsModerate Depression, Menopausal and Postmenopausal DisordersArmsIndividualized homeopathic treatment, Fluoxetine, Placebo
3 · Its place in the literature

Who cites it

86 citing papers in PubMed, 1 synthesis or guideline pooled it, 191 citations in OpenAlex.

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  20. A cognitive-emotional biomarker for predicting remission with antidepressant medications: a report from the iSPOT-D trial.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2015
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26 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 7 institutions in 3 countries.

Leanne M WilliamsBRAINnet Foundation, 71 Stephenson Street, Suite 400, San Francisco, CA, 94105, USA. lea.williams@brainnet.net
A John Rush
Stephen H Koslow
Stephen R Wisniewski
Nicholas J Cooper
Charles B Nemeroff
Alan F Schatzberg
Evian Gordon
Brain Research Foundation · USBrain Resource Center · USDuke-NUS Medical School · SGStanford University · USUniversity of Miami · USUniversity of Pittsburgh · USWestmead Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClinically 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/

designThe 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 registrationInternational 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

Indexed as

Research DesignAdolescentAdultAgedAntidepressive Agents, Second-GenerationAustraliaCitalopramCognitionCyclohexanolsDecision Support TechniquesElectroencephalographyEmotionsEuropeFemaleHumansMajor Depressive DisorderAntidepressive Agents, Second-GenerationCitalopramCyclohexanolsSelective Serotonin Reuptake InhibitorsSertralineVenlafaxine Hydrochloride

Identifiers

PMID21208417
PMCPMC3036635
OpenAlexW2139821383

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.