Quetiapine versus aripiprazole in children and adolescents with psychosis - protocol for the randomised, blinded clinical Tolerability and Efficacy of Antipsychotics (TEA) trial
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Quetiapine versus aripiprazole in children and adolescents with psychosis - protocol for the randomised, blinded clinical Tolerability and Efficacy of Antipsychotics (TEA) trial. / Pagsberg, Anne Katrine; Jeppesen, Pia; Klauber, Dea Gowers; Jensen, Karsten Gjessing; Rudå, Ditte; Stentebjerg-Olesen, Marie; Jantzen, Peter; Rasmussen, Simone; Saldeen, Eva Ann-Sofie; Lauritsen, Maj-Britt Glenn; Bilenberg, Niels; Stenstrøm, Anne Dorte; Pedersen, Jesper; Nyvang, Louise; Madsen, Sarah; Lauritsen, Marlene B; Vernal, Ditte Lammers; Thomsen, Per Hove; Paludan, Jakob; Werge, Thomas M; Winge, Kristian; Juul, Klaus; Gluud, Christian; Skoog, Maria; Wetterslev, Jørn; Jepsen, Jens Richardt M; Correll, Christoph U; Fink-Jensen, Anders; Fagerlund, Birgitte.
I: B M C Psychiatry, Bind 14, 199, 2014, s. 1-13.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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T1 - Quetiapine versus aripiprazole in children and adolescents with psychosis - protocol for the randomised, blinded clinical Tolerability and Efficacy of Antipsychotics (TEA) trial
AU - Pagsberg, Anne Katrine
AU - Jeppesen, Pia
AU - Klauber, Dea Gowers
AU - Jensen, Karsten Gjessing
AU - Rudå, Ditte
AU - Stentebjerg-Olesen, Marie
AU - Jantzen, Peter
AU - Rasmussen, Simone
AU - Saldeen, Eva Ann-Sofie
AU - Lauritsen, Maj-Britt Glenn
AU - Bilenberg, Niels
AU - Stenstrøm, Anne Dorte
AU - Pedersen, Jesper
AU - Nyvang, Louise
AU - Madsen, Sarah
AU - Lauritsen, Marlene B
AU - Vernal, Ditte Lammers
AU - Thomsen, Per Hove
AU - Paludan, Jakob
AU - Werge, Thomas M
AU - Winge, Kristian
AU - Juul, Klaus
AU - Gluud, Christian
AU - Skoog, Maria
AU - Wetterslev, Jørn
AU - Jepsen, Jens Richardt M
AU - Correll, Christoph U
AU - Fink-Jensen, Anders
AU - Fagerlund, Birgitte
PY - 2014
Y1 - 2014
N2 - 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.
AB - 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.
U2 - 10.1186/1471-244X-14-199
DO - 10.1186/1471-244X-14-199
M3 - Journal article
C2 - 25015535
VL - 14
SP - 1
EP - 13
JO - B M C Psychiatry
JF - B M C Psychiatry
SN - 1471-244X
M1 - 199
ER -
ID: 138132754