Evidence map›Paper›PMID 22251022›Full record

Trial reportJournal of child and adolescent psychopharmacology2012

Out of the black box: treatment of resistant depression in adolescents and the antidepressant controversy.

Karen Dineen Wagner, Joan Rosenbaum Asarnow, Benedetto Vitiello, Gregory Clarke, Martin Keller, Graham J Emslie, Neal Ryan, Giovanna Porta, Satish Iyengar, Louise Ritz and 3 more

Erratum issued Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of child and adolescent psychopharmacology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00018902 (Treatment of SSRI-Resistant Depression in Adolescents), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.8field-weighted citation impact, top 11% 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.

NCT00018902 phase2 / phase3completednot on this map

Treatment of SSRI-Resistant Depression in Adolescents (TORDIA)

TypeinterventionalSponsorUniversity of PittsburghRan2001 to 2007Enrolled334ConditionsDepressionArmsFluoxetine, Venlafaxine, Cognitive Behavioral Therapy (CBT), Citalopram
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 14 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Review
  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 6 institutions in 1 country.

Karen Dineen WagnerDivision of Child and Adolescent Psychiatry, The University of Texas Medical Branch, Galveston, Texas 77555, USA. kwagner@utmb.edu
Joan Rosenbaum Asarnow
Benedetto Vitiello
Gregory Clarke
Martin Keller
Graham J Emslie
Neal Ryan
Giovanna Porta
Satish Iyengar
Louise Ritz
Jamie Zelanzny
Matthew Onorato
David Brent
University of Pittsburgh · USBrown University · USKaiser Permanente Center for Health Research · USThe Ohio State University · USThe University of Texas Southwestern Medical Center · USUniversity of California, Los Angeles · US

Funding

Core--Research network developmentP30MH066371 · NIMH · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI BRENT, DAVID A. · 2002 to 2006
$8.2M
TREATMENT OF SSRI RESISTANT DEPRESSION IN ADOLESCENTSU01MH061835 · NIMH · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI BRENT, DAVID A. · 2000 to 2006
$3.3M
TREATMENT OF SSRI RESISTANT DEPRESSION IN ADOLESCENTSU01MH061869 · NIMH · KAISER FOUNDATION RESEARCH INSTITUTE · PI CLARKE, GREGORY N · 2000 to 2006
$2.8M
TREATMENT OF SSRI RESISTANT DEPRESSION IN ADOLESCENTSU01MH061856 · NIMH · UNIVERSITY OF TEXAS MEDICAL BR GALVESTON · PI WAGNER, KAREN D · 2000 to 2006
$1.9M
TREATMENT OF SSRI RESISTANT DEPRESSION IN ADOLESCENTSU01MH061958 · NIMH · UT SOUTHWESTERN MEDICAL CENTER · PI EMSLIE, GRAHAM J. · 2000 to 2006
$1.8M
TREATMENT OF SSRI RESISTANT DEPRESSION IN ADOLESCENTSU01MH061864 · NIMH · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ASARNOW, JOAN ROSENBAUM · 2000 to 2006
$1.5M
TREATMENT OF SSRI-RESISTANT DEPRESSION IN ADOLESCENTSU01MH062014 · NIMH · BROWN UNIVERSITY · PI KELLER, MARTIN B · 2000 to 2006
$1.5M
NIMH NIH HHS MH61835NIMH NIH HHS MH61856NIMH NIH HHS MH61864NIMH NIH HHS MH61869NIMH NIH HHS MH61958NIMH NIH HHS MH62014NIMH NIH HHS MH66371NIMH NIH HHS U01 MH062014
6 · The paper itself

Abstract

objectiveThe purpose of this article is to describe the effects of the pediatric antidepressant controversy on the Treatment of Serotonin-Selective Reuptake Inhibitor (SSRI) Resistant Depression in Adolescents (TORDIA) trial.

methodAdolescents, ages 12-18 years, with SSRI resistant depression were randomized to one of four treatments for a 12 week trial: Switch to different SSRI, switch to an alternate antidepressant (venlafaxine), switch to an alternate SSRI plus cognitive behavior therapy (CBT), or switch to venlafaxine plus CBT.

resultsThe health advisories and "black box" warnings regarding suicidality and antidepressants in adolescents occurred during the course of the TORDIA trial. Revisions to the protocol, multiple-consent form changes, and re-consenting of patients were necessary. Recruitment of participants was adversely affected.

conclusionDespite a cascade of unforeseen events that delayed the completion of the study, the TORDIA trial resulted in clinically important information about treatment-resistant depression in adolescents.

Indexed as

AdolescentChildCognitive Behavioral TherapyCombined Modality TherapyCyclohexanolsDrug LabelingDrug ResistanceHumansMajor Depressive DisorderPatient SelectionSelective Serotonin Reuptake InhibitorsSuicide PreventionVenlafaxine HydrochlorideCyclohexanolsSelective Serotonin Reuptake InhibitorsVenlafaxine Hydrochloride

Identifiers

PMID22251022
PMCPMC3281287
OpenAlexW2004579270

What OpenQuestion holds

Textmetadata
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.