Evidence map›Paper›PMID 26598476›Full record

Trial reportJournal of the American Academy of Child and Adolescent Psychiatry2015

Treatment of Early-Age Mania: Outcomes for Partial and Nonresponders to Initial Treatment.

John T Walkup, Karen Dineen Wagner, Leslie Miller, Gayane Yenokyan, Joan L Luby, Paramjit T Joshi, David A Axelson, Adelaide Robb, Jay A Salpekar, Dwight Wolf and 4 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed 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 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
2.5field-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.

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

5 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Valproate for acute mania.The Cochrane database of systematic reviews · 2019
    Review
  4. Review
  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 10 institutions in 1 country.

John T WalkupWeill Cornell Medical College, New York Presbyterian Hospital, New York. Electronic address: jtw9001@med.cornell.edu.
Karen Dineen WagnerUniversity of Texas Medical Branch, Galveston.
Leslie MillerJohns Hopkins University School of Medicine, Baltimore.
Gayane YenokyanJohns Hopkins Bloomberg School of Public Health.
Joan L LubyWashington University in St. Louis.
Paramjit T JoshiChildren's National Medical Center, George Washington University School of Medicine, Washington, DC.
David A AxelsonNationwide Children's Hospital and The Ohio State University/Wexner Medical Center, Columbus.
Adelaide RobbChildren's National Medical Center, George Washington University School of Medicine, Washington, DC.
Jay A SalpekarChildren's National Medical Center, George Washington University School of Medicine, Washington, DC.
Dwight WolfUniversity of Texas Medical Branch, Galveston.
Abanti SanyalJohns Hopkins Bloomberg School of Public Health.
Boris BirmaherUniversity of Pittsburgh Medical Center/Western Psychiatric Institute and Clinic, Pittsburgh.
Benedetto VitielloNational Institute of Mental Health (NIMH), Bethesda, MD.
Mark A RiddleJohns Hopkins University School of Medicine, Baltimore.
George Washington University · USJohns Hopkins Medicine · USJohns Hopkins University · USThe University of Texas Medical Branch at Galveston · USChildren's National · USCornell University · USNational Institute of Mental Health · USThe Ohio State University Wexner Medical Center · USUniversity of Pittsburgh Medical Center · 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 1UL1TR001079NIMH 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

objectiveThe Treatment of Early Age Mania (TEAM) study evaluated lithium, risperidone, and divalproex sodium (divalproex) in children with bipolar I disorder who were naive to antimanic medication, or were partial or nonresponders to 1 of 3 study medications. This report evaluates the benefit of either an add-on or a switch of antimanic medications for an 8-week trial period in partial responders and nonresponders, respectively.

methodTEAM is a randomized, controlled trial of individuals (N = 379) aged 6 to 15 years (mean ± SD = 10.2 ± 2.7 years) with DSM-IV bipolar I disorder (mixed or manic phase). Participants (n = 154) in this report were either nonresponders or partial responders to 1 of the 3 study medications. Nonresponders (n = 89) were randomly assigned to 1 of the other 2 antimanic medications and cross-tapered. Partial responders (n = 65) were randomly assigned to 1 of 2 other antimanic medications as an add-on to their initial medication. Adverse event (AE) rates are reported only for the add-on group.

resultsResponse rate for children switched to risperidone (47.6%) was higher than for those switched to either lithium (12.8%; p = .005; number needed to treat [NNT] = 3; 95% CI = 1.71-9.09) or divalproex (17.2%; p = .03; NNT = 3; 95% CI = 1.79-20.10); response rate for partial responders who added risperidone (53.3%) was higher than for those who added divalproex (0%; p = .0002; NNT = 2; 95% CI = 1.27-3.56) and trended higher for lithium (26.7%; p = .07; NNT = 4). Reported AEs in the add-on group were largely consistent with the known AE profile for the second medication. Weight gain (kg) was observed for all add-on medications: lithium add-on (n = 29 of 30) = 1.66 ± 1.97; risperidone add-on (n = 15 of 15) = 2.8 ± 1.34; divalproex add-on (n = 19 of 20) = 1.42 ± 1.96. There was no evidence at the 5% significance level that the average weight gain was different by study medication for partial responders (p = .07, 1-way analysis of variance).

conclusionRisperidone appears to be more useful than lithium or divalproex for children with bipolar I disorder and other comorbid conditions who are nonresponders or partial responders to an initial antimanic medication trial. 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 AgentsBipolar DisorderChildDrug Therapy, CombinationFemaleHumansLithium CarbonateMaleMedication AdherenceRisperidoneTreatment OutcomeUnited StatesValproic AcidAntimanic AgentsLithium CarbonateRisperidoneValproic Acidbipolarmanianonresponderspharmacologytreatment

Identifiers

PMID26598476
OpenAlexW2178662420

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.