Evidence map›Paper›PMID 26598475›Full record

Trial reportJournal of the American Academy of Child and Adolescent Psychiatry2015

Depression and Suicidality Outcomes in the Treatment of Early Age Mania Study.

Jay A Salpekar, Paramjit T Joshi, David A Axelson, Shauna P Reinblatt, Gayane Yenokyan, Abanti Sanyal, John T Walkup, Benedetto Vitiello, Joan L Luby, Karen Dineen Wagner and 2 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the American Academy of Child and Adolescent Psychiatry, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00057681 (Treatment of Early Age Mania), which is not on this map. Cited by 9 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 3 pooled it
5.5field-weighted citation impact, top 3% 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.

NCT00057681 phase3completednot on this map

Treatment of Early Age Mania (TEAM) Study

TypeinterventionalSponsorWashington University School of MedicineRan2003 to 2008Enrolled379ConditionsBipolar DisorderArmsLithium carbonate, Valproate, Risperidone
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 3 syntheses or guidelines pooled it, 40 citations in OpenAlex.

  1. Pooled it
  2. Lithium for acute mania.The Cochrane database of systematic reviews · 2019
    Pooled it
  3. Pooled it
  4. Trial
  5. Review
  6. Review
  7. Article
  8. Article
  9. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 8 institutions in 1 country.

Jay A SalpekarKennedy Krieger Institute and Johns Hopkins University School of Medicine, Baltimore. Electronic address: Salpekar@kennedykrieger.org.
Paramjit T JoshiChildren's National Medical Center and George Washington University, Washington, DC; American Academy of Child and Adolescent Psychiatry (AACAP) and with the American Board of Psychiatry and Neurology (ABPN).
David A AxelsonNationwide Children's Hospital and The Ohio State University, Columbus.
Shauna P ReinblattJohns Hopkins University School of Medicine.
Gayane YenokyanJohns Hopkins Biostatistics Center at Johns Hopkins Bloomberg School of Public Health.
Abanti SanyalJohns Hopkins Biostatistics Center at Johns Hopkins Bloomberg School of Public Health.
John T WalkupNew York Presbyterian Hospital-Weill Cornell Medical College, New York.
Benedetto VitielloNational Institute of Mental Health (NIMH), Bethesda, MD.
Joan L LubyWashington University in St. Louis.
Karen Dineen WagnerUniversity of Texas Medical Branch at Galveston.
Nasima NusratChildren's National Medical Center and George Washington University, Washington, DC.
Mark A RiddleJohns Hopkins University School of Medicine.
Johns Hopkins University · USAmerican Academy of Child and Adolescent Psychiatry · USChildren's National · USNational Institute of Mental Health · USPresbyterian Hospital · USThe Ohio State University · USThe University of Texas Medical Branch at Galveston · USWashington University in St. Louis · US

Funding

Institute for Clinical and Translational ResearchUL1TR001079 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2013 to 2017
$60.1M
Treatment of Early Age Mania (TEAM)U01MH064846 · NIMH · WASHINGTON UNIVERSITY · PI GELLER, BARBARA · 2002 to 2008
$4.8M
Treatment of Early Age Mania StudyU01MH064869 · NIMH · JOHNS HOPKINS UNIVERSITY · PI RIDDLE, MARK A · 2002 to 2008
$3.3M
Treatment of Early-Age ManiaU01MH064851 · NIMH · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI AXELSON, DAVID A · 2002 to 2008
$2.7M
Treatment of Early Age ManiaU01MH064850 · NIMH · UNIVERSITY OF TEXAS MEDICAL BR GALVESTON · PI WAGNER, KAREN D · 2002 to 2008
$2.7M
Treatment of Early Age Mania (TEAM)U01MH064887 · NIMH · CHILDREN'S RESEARCH INSTITUTE · PI JOSHI, PARAMJIT T. · 2002 to 2008
$2.6M
Treatment of Early Age Mania (TEAM)U01MH064868 · NIMH · WASHINGTON UNIVERSITY · PI LUBY, JOAN L. · 2002 to 2008
$2.4M
Treatment of Early Age Mania (TEAM)U01MH064911 · NIMH · UNIVERSITY OF TEXAS SW MED CTR/DALLAS · PI EMSLIE, GRAHAM J. · 2002 to 2003
$777k
NCATS NIH HHS 1UL1TR001079NCATS NIH HHS UL1 TR001079NIMH NIH HHS U01 MH064846NIMH NIH HHS U01 MH064850NIMH NIH HHS U01 MH064851NIMH NIH HHS U01 MH064868NIMH NIH HHS U01 MH064869NIMH NIH HHS U01 MH064887NIMH NIH HHS U01 MH064911
6 · The paper itself

Abstract

objectiveTo assess the efficacy of mood-stabilizing medications for depression and suicidality in pediatric bipolar disorder.

methodThe Treatment of Early Age Mania (TEAM) study is a multicenter, prospective, randomized, masked comparison of divalproex sodium (VAL), lithium carbonate (LI), and risperidone (RISP) in an 8-week parallel clinical trial. A total of 279 children and adolescents with DSM-IV diagnoses of bipolar I disorder, mixed or manic, aged 6 to 15 years were enrolled. The primary outcome measure was improvement on the Clinical Global Impression scale for depression (CGI-BP-I-D). Secondary outcome measures included the Children's Depression Rating Scale (CDRS-R) and suicidality status. Statistics included longitudinal analysis of outcomes using generalized linear mixed models with random intercept both for the complete data set and by using last observation carried forward.

resultsCGI-BP-I-D ratings were better in the RISP group (60.7%) as compared to the LI (42.2%; p = .03) or VAL (35.0%; p = .003) groups from baseline to the end of the study. CDRS scores in all treatment groups improved equally by study end. In week 1, scores were lower with RISP compared to VAL (mean = 4.72, 95% CI = 2.67, 6.78), and compared to LI (mean = 3.63, 95% CI = 1.51, 5.74), although group differences were not present by the end of the study. Suicidality was infrequent, and there was no overall effect of treatment on suicidality ratings.

conclusionDepressive symptoms, present in the acutely manic or mixed phase of pediatric bipolar disorder, improved with all 3 medications, though RISP appeared to yield more rapid improvement than LI or VAL and was superior using a global categorical outcome. Clinical trial registration information-Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents (TEAM); http://clinicaltrials.gov; NCT00057681.

Indexed as

AdolescentAntimanic AgentsAntipsychotic AgentsBipolar DisorderChildDepressionFemaleHumansLithium CarbonateLogistic ModelsMalePatient ComplianceProspective StudiesRisperidoneSuicideTreatment OutcomeAntimanic AgentsAntipsychotic AgentsLithium CarbonateRisperidoneValproic Acidbipolarclinical trialdepressionpediatricstreatment

Identifiers

PMID26598475
PMCPMC4660262
OpenAlexW2173930376

What OpenQuestion holds

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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.