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BMC Psychiatry
Published in: BMC Psychiatry 1/2014

Open Access 01-12-2014 | Study protocol

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

Authors: 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, 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

Published in: BMC Psychiatry | Issue 1/2014

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Abstract

Background

The 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/Design

The 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 registration

ClinicalTrials.gov: NCT01119014
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Metadata
Title
Quetiapine versus aripiprazole in children and adolescents with psychosis - protocol for the randomised, blinded clinical Tolerability and Efficacy of Antipsychotics (TEA) trial
Authors
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
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
Publication date
01-12-2014
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2014
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/1471-244X-14-199

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