Per Hove Thomsen

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

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

  • Anne Katrine Pagsberg, Child and Adolescent Mental Health Center, Mental Health Services, the Capital Region of Denmark, Glostrup, Denmark; Faculty of Health Science, University of Copenhagen, Copenhagen, Denmark., Danmark
  • Pia Jeppesen, Child and Adolescent Mental Health Center, Mental Health Services, the Capital Region of Denmark, Glostrup, Denmark; Faculty of Health Science, University of Copenhagen, Copenhagen, Denmark., Danmark
  • Dea Gowers Klauber, Child and Adolescent Mental Health Center, Mental Health Services, the Capital Region of Denmark, Glostrup, Denmark; Faculty of Health Science, University of Copenhagen, Copenhagen, Denmark., Danmark
  • Karsten Gjessing Jensen, Child and Adolescent Mental Health Center, Mental Health Services, the Capital Region of Denmark, Glostrup, Denmark; Faculty of Health Science, University of Copenhagen, Copenhagen, Denmark., Danmark
  • Ditte Rudå, Child and Adolescent Mental Health Center, Mental Health Services, the Capital Region of Denmark, Glostrup, Denmark; Faculty of Health Science, University of Copenhagen, Copenhagen, Denmark., Ukendt
  • Marie Stentebjerg-Olesen, Child and Adolescent Mental Health Center, Mental Health Services, the Capital Region of Denmark, Glostrup, Denmark; Faculty of Health Science, University of Copenhagen, Copenhagen, Denmark., Ukendt
  • Peter Jantzen, Child and Adolescent Mental Health Center, Mental Health Services, the Capital Region of Denmark, Glostrup, Denmark; Faculty of Health Science, University of Copenhagen, Copenhagen, Denmark., Ukendt
  • Simone Rasmussen, Child and Adolescent Mental Health Center, Mental Health Services, the Capital Region of Denmark, Glostrup, Denmark; Faculty of Health Science, University of Copenhagen, Copenhagen, Denmark., Danmark
  • Eva Ann-Sofie Saldeen, Child and Adolescent Mental Health Center, Mental Health Services, the Capital Region of Denmark, Glostrup, Denmark; Faculty of Health Science, University of Copenhagen, Copenhagen, Denmark., Ukendt
  • Maj-Britt Glenn Lauritsen, Child and Adolescent Mental Health Center, Mental Health Services, the Capital Region of Denmark, Glostrup, Denmark; Faculty of Health Science, University of Copenhagen, Copenhagen, Denmark., Ukendt
  • Niels Bilenberg, Child and Adolescent Psychiatry Research Unit, Region of Southern Denmark, University of Southern Denmark, Danmark
  • Anne Dorte Stenstrøm, Child and Adolescent Psychiatry Research Unit, Region of Southern Denmark, University of Southern Denmark, Ukendt
  • Jesper Pedersen, Mental Health Centre for Child and Adolescent Psychiatry Region Zealand, Research Unit, University of Copenhagen, Smedegade 16, Roskilde, Danmark
  • Louise Nyvang, Ukendt
  • Sarah Madsen
  • ,
  • Marlene Briciet Lauritsen, Psykiatrien, Danmark
  • Ditte Lammers Vernal
  • Per Hove Thomsen
  • Jakob Paludan, Danmark
  • Thomas M Werge
  • ,
  • Kristian Winge, Ukendt
  • Klaus Juul, Ukendt
  • Christian Gluud
  • ,
  • Maria Skoog
  • ,
  • Jørn Wetterslev
  • ,
  • Jens Richardt M. Jepsen, Centre for Neuropsychiatric Schizophrenia Research and Lundbeck Foundation Centre for CLinical Intervention and Neuropsychiatric Schizophrenia Research, Psychiatric Centre Glostrup, Danmark
  • Christoph U Correll
  • ,
  • Anders Fink-Jensen
  • ,
  • Birgitte Fagerlund

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.

OriginalsprogEngelsk
TidsskriftB M C Psychiatry
Vol/bind14
Nummer199
Sider (fra-til)199
Antal sider13
ISSN1471-244X
DOI
StatusUdgivet - 2014

    Forskningsområder

  • antipsychotics, psychosis, schizophrenia, Children, Adolescents, Randomised trial

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