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; 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

doi:10.1186/1471-244X-14-199

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, Niels Bilenberg, Anne Dorte Stenstrøm, Jesper Pedersen, Louise Nyvang, Sarah Madsen, Marlene B Lauritsen, Ditte Lammers Vernal, Per Hove Thomsen, Jakob Paludan, Thomas M WergeKristian Winge, Klaus Juul, Christian Gluud, Maria Skoog, Jørn Wetterslev, Jens Richardt M Jepsen, Christoph U Correll, Anders Fink-Jensen, Birgitte Fagerlund

11 Citations (Scopus)

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.

Original language	English
Article number	199
Journal	B M C Psychiatry
Volume	14
Pages (from-to)	1-13
Number of pages	13
ISSN	1471-244X
DOIs	https://doi.org/10.1186/1471-244X-14-199
Publication status	Published - 11 Jul 2014

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Pagsberg, A. K., Jeppesen, P., Klauber, D. G., Jensen, K. G., Rudå, D., Stentebjerg-Olesen, M., Jantzen, P., Rasmussen, S., Saldeen, E. A-S., Lauritsen, M-B. G., Bilenberg, N., Stenstrøm, A. D., Pedersen, J., Nyvang, L., Madsen, S., Lauritsen, M. B., Vernal, D. L., Thomsen, P. H., Paludan, J., ... Fagerlund, B. (2014). Quetiapine versus aripiprazole in children and adolescents with psychosis - protocol for the randomised, blinded clinical Tolerability and Efficacy of Antipsychotics (TEA) trial. B M C Psychiatry, 14, 1-13. [199]. https://doi.org/10.1186/1471-244X-14-199

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 et al.

In: B M C Psychiatry, Vol. 14, 199, 11.07.2014, p. 1-13.

Research output: Contribution to journal › Journal article › Research › peer-review

Pagsberg, AK , Jeppesen, P, Klauber, DG, Jensen, KG, Rudå, D, Stentebjerg-Olesen, M, Jantzen, P, Rasmussen, S, Saldeen, EA-S, Lauritsen, M-BG, Bilenberg, N, Stenstrøm, AD, Pedersen, J, Nyvang, L, Madsen, S, Lauritsen, MB, Vernal, DL, Thomsen, PH, Paludan, J, Werge, TM, Winge, K, Juul, K, Gluud, C, Skoog, M, Wetterslev, J, Jepsen, JRM, Correll, CU, Fink-Jensen, A & Fagerlund, B 2014, 'Quetiapine versus aripiprazole in children and adolescents with psychosis - protocol for the randomised, blinded clinical Tolerability and Efficacy of Antipsychotics (TEA) trial', B M C Psychiatry, vol. 14, 199, pp. 1-13. https://doi.org/10.1186/1471-244X-14-199

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

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-na{\"i}ve 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.",

author = "Pagsberg, {Anne Katrine} and Pia Jeppesen and Klauber, {Dea Gowers} and Jensen, {Karsten Gjessing} and Ditte Rud{\aa} and Marie Stentebjerg-Olesen and Peter Jantzen and Simone Rasmussen and Saldeen, {Eva Ann-Sofie} and Lauritsen, {Maj-Britt Glenn} and Niels Bilenberg and Stenstr{\o}m, {Anne Dorte} and Jesper Pedersen and Louise Nyvang and Sarah Madsen and Lauritsen, {Marlene B} and Vernal, {Ditte Lammers} and Thomsen, {Per Hove} and Jakob Paludan and Werge, {Thomas M} and Kristian Winge and Klaus Juul and Christian Gluud and Maria Skoog and J{\o}rn Wetterslev and Jepsen, {Jens Richardt M} and Correll, {Christoph U} and Anders Fink-Jensen and Birgitte Fagerlund",

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doi = "10.1186/1471-244X-14-199",

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journal = "B M C Psychiatry",

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TY - JOUR

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 - 2014/7/11

Y1 - 2014/7/11

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

SN - 1471-244X

VL - 14

SP - 1

EP - 13

JO - B M C Psychiatry

JF - B M C Psychiatry

M1 - 199

ER -

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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