Evidence map›Paper›PMID 25015535›Full record

Trial reportBMC psychiatry2014

Quetiapine versus aripiprazole in children and adolescents with psychosis--protocol for the randomised, blinded clinical Tolerability and Efficacy of Antipsychotics (TEA) trial.

Anne Katrine Pagsberg, Pia Jeppesen, Dea Gowers Klauber, Karsten Gjessing Jensen, Ditte Rudå, Marie Stentebjerg-Olesen, Peter Jantzen, Simone Rasmussen, Eva Ann-Sofie Saldeen, Maj-Britt Glenn Lauritsen and 19 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC psychiatry, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01119014 (Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis- An Investigator-initiated, Phase IV, Randomised Double-blind Multi-centre Trial of the Benefits and Harms of Aripiprazole Versus Quetiapine in Children and Adolescents With Psychosis), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.8field-weighted citation impact, top 27% 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.

NCT01119014 phase4completednot on this map

Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis- An Investigator-initiated, Phase IV, Randomised Double-blind Multi-centre Trial of the Benefits and Harms of Aripiprazole Versus Quetiapine in Children and Adolescents With Psychosis

TypeinterventionalSponsorAnne Katrine PagsbergRan2010 to 2015Enrolled300ConditionsPsychosisArmsAripiprazole, Quetiapine
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
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

29 authors at 14 institutions in 2 countries.

Anne Katrine PagsbergChild and Adolescent Mental Health Center, Mental Health Services - Capital Region of Denmark & Faculty of Health Science University of Copenhagen, Nordre Ringvej 69, Glostrup DK- 2600, Denmark. Anne.Katrine.Pagsberg@Regionh.dk.
Pia Jeppesen
Dea Gowers Klauber
Karsten Gjessing Jensen
Ditte Rudå
Marie Stentebjerg-Olesen
Peter Jantzen
Simone Rasmussen
Eva Ann-Sofie Saldeen
Maj-Britt Glenn Lauritsen
Niels Bilenberg
Anne Dorte Stenstrøm
Jesper Pedersen
Louise Nyvang
Sarah Madsen
Marlene B Lauritsen
Ditte Lammers Vernal
Per Hove Thomsen
Jakob Paludan
Thomas M Werge
Kristian Winge
Klaus Juul
Christian Gluud
Maria Skoog
Jørn Wetterslev
Jens Richardt M Jepsen
Christoph U Correll
Anders Fink-Jensen
Birgitte Fagerlund
University of Copenhagen · DKCapital Region of Denmark · DKRigshospitalet · DKMental Health Services · DKNorth Denmark Region · DKRegion Zealand · DKUniversity of Southern Denmark · DKAarhus University · DKBispebjerg Hospital · DKCentral Denmark Region · DKLundbeck (Denmark) · DKLundbeck Foundation · DKPsychiatry Region Zealand · DKZucker Hillside Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe evidence for choices between antipsychotics for children and adolescents with schizophrenia and other psychotic disorders is limited. The main objective of the Tolerability and Efficacy of Antipsychotics (TEA) trial is to compare the benefits and harms of quetiapine versus aripiprazole in children and adolescents with psychosis in order to inform rational, effective and safe treatment selections. METHODS/

designThe TEA trial is a Danish investigator-initiated, independently funded, multi-centre, randomised, blinded clinical trial. Based on sample size estimation, 112 patients aged 12-17 years with psychosis, antipsychotic-naïve or treated for a limited period are, 1:1 randomised to a 12- week, double-blind intervention with quetiapine versus aripiprazole. Effects on psychopathology, cognition, health-related quality of life, and adverse events are assessed 2, 4, and 12 weeks after randomisation. The primary outcome is change in the positive symptom score of the Positive and Negative Syndrome Scale. The recruitment period is 2010-2014. DISCUSSION: Antipsychotics are currently the only available pharmacologic treatments for psychotic disorders. However, information about head-to-head differences in efficacy and tolerability of antipsychotics are scarce in children and adolescents. The TEA trial aims at expanding the evidence base for the use of antipsychotics in early onset psychosis in order to inform more rational treatment decisions in this vulnerable population. Here, we account for the trial design, address methodological challenges, and discuss the estimation of sample size.

trial registrationClinicalTrials.gov: NCT01119014.

Indexed as

AdolescentAntipsychotic AgentsAripiprazoleChildDibenzothiazepinesDouble-Blind MethodFemaleHumansMalePatient SelectionPiperazinesPsychotic DisordersQuality of LifeQuetiapine FumarateQuinolonesSample SizeAntipsychotic AgentsAripiprazoleDibenzothiazepinesPiperazinesQuetiapine FumarateQuinolones

Identifiers

PMID25015535
PMCPMC4227115
OpenAlexW2110355918

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.